Washington Study of Hemofiltration After Out-of-Hospital Cardiac Arrest

• Sponsor: University of Washington (Other)
• Overall Status: Completed
• CT.gov ID: NCT01509040
• Collaborator: (none)
• Enrollment: 2
• Location: 1
• Arms: 3
• Duration (Months): 29
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the feasibility of hemofiltration in patients resuscitated from cardiac arrest. Cardiac arrest is the loss of mechanical activity of the heart including the loss of detectable pulse, or spontaneous breathing. When heart function is restored, the cells of the body release molecules into the blood that cause inflammation, unstable blood pressure, organ dysfunction and death. Hemofiltration is a technique of washing the blood to remove fluid and molecules from it. Hemofiltration is a proven therapy for renal failure, but is considered investigational for treatment after resuscitation from cardiac arrest. Some experts believe that hemofiltration after heart function is restored can remove inflammation from the blood, maintain blood pressure and organ function. Others believe that intravenous fluid and medications are sufficient to maintain blood pressure and organ function. Since the inflammation that occurs after restoration of heart function lasts, the investigators continue hemofiltration for up to 48 hours. Whether hemofiltration or intravenous fluids and medications is better is not known. The investigators are checking if they can wash the blood of patients resuscitated from cardiac arrest before the investigators can begin a large randomized trial to test whether hemofiltration improves their outcome.

The investigators are testing this by randomly allocating patients resuscitated from cardiac arrest to receive low volume hemofiltration, high volume hemofiltration, or intravenous fluids and medications alone. The null hypotheses are that less than 80% of eligible patients will be enrolled, and that less than 80% of enrolled patients will undergo low-volume or high-volume hemofiltration (HF) for at least 80% of 48 hours.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Arrest	Other: Standard Care; Device: Low Volume Hemofiltration; Device: High Volume Hemofiltration	Phase 1/Phase 2

Detailed Description

Patients resuscitated from out-of-hospital cardiac arrest will be randomly allocated to one of three groups; Standard of care: Initiate standard of post-resuscitative care including a triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious. Fluids, inotropes, vasopressors, vasodilators to maintain hemodynamics.

Low-volume Hemofiltration for 48 hours: Initiate standard of post-resuscitative care including a triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious. Hemofiltration x 48 hours via a 11.5F double lumen venous catheter, blood flow 250mL/h, ultrafiltration 45mL/kg/h. Fluids, inotropes, vasopressors, vasodilators to maintain hemodynamics.

High-volume Hemofiltration for 48 hours: Initiate standard of post-resuscitative care including a triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 90 mL/kg/h. Fluids, inotropes, vasopressors, vasodilators to maintain hemodynamics.

30 patients will be enrolled.

Study Design

• Study Type: Interventional
• Actual Enrollment: 2 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Washington Study of Hemofiltration After Out-of-Hospital Cardiac Arrest
• Study Start Date: Jan 1, 2012
• Actual Primary Completion Date: Nov 1, 2013
• Actual Study Completion Date: Jun 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Control Initiate standard post-resuscitative care including a triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious. Fluids, 500-mL bolus of intravenous crystalloid given every 30 minutes to achieve a central venous pressure of 8 to 12 mm Hg; inotropes, vasopressors if mean arterial pressure is less than 65 mm Hg; vasodilators, if mean arterial pressure is 90 mm Hg or above to maintain hemodynamics.	Other: Standard Care; Triple-lumen central venous catheter inserted for pressure monitoring. All patients to receive 500-mL bolus of intravenous crystalloid every 30 minutes to achieve central venous pressure of 8 to 12 mm Hg; vasopressors if mean arterial pressure less than 65 mm Hg; and vasodilators if mean arterial pressure is 90 mm Hg or above. Initiation and maintenance of therapeutic hypothermia, target core temperature of below 34°C via standard external cooling techniques. Percutaneous coronary intervention performed as soon as feasible in patients with ST elevation or left bundle branch block on initial ECG. Serum biochemistry (including sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate) monitored every 6 hours.
Experimental: Low Volume Hemofiltration Initiate standard post-resuscitative care including a triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h. Fluids, 500-mL bolus of intravenous crystalloid given every 30 minutes to achieve a central venous pressure of 8 to 12 mm Hg; inotropes, vasopressors if mean arterial pressure is less than 65 mm Hg; vasodilators, if mean arterial pressure is 90 mm Hg or above to maintain hemodynamics.	Other: Standard Care; Triple-lumen central venous catheter inserted for pressure monitoring. All patients to receive 500-mL bolus of intravenous crystalloid every 30 minutes to achieve central venous pressure of 8 to 12 mm Hg; vasopressors if mean arterial pressure less than 65 mm Hg; and vasodilators if mean arterial pressure is 90 mm Hg or above. Initiation and maintenance of therapeutic hypothermia, target core temperature of below 34°C via standard external cooling techniques. Percutaneous coronary intervention performed as soon as feasible in patients with ST elevation or left bundle branch block on initial ECG. Serum biochemistry (including sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate) monitored every 6 hours.; Device: Low Volume Hemofiltration; Patients will receive isovolemic HF at a blood flow rate of 250 mL/min and ultrafiltration rate of 45 mL/kg/h for 48 hours. Initial replacement solution will be Prismasol BGK4/2.5. 3.1mg/dL phosphate (1.0 mmol/L) added to each bag. Replacement fluid adjusted as required based on chemistry values for sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate. Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution used. HF 1400 (i.e. polysulfone -based membrane) filters used throughout study. Hemofilter changed every 6 h after initiation of HF, and as required.
Experimental: High Volume Hemofiltration Initiate standard post-resuscitative care including a triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/kg/h, ultrafiltration 90 mL/kg/h. Fluids, 500-mL bolus of intravenous crystalloid given every 30 minutes to achieve a central venous pressure of 8 to 12 mm Hg; inotropes, vasopressors if mean arterial pressure is less than 65 mm Hg; vasodilators, if mean arterial pressure is 90 mm Hg or above to maintain hemodynamics.	Other: Standard Care; Triple-lumen central venous catheter inserted for pressure monitoring. All patients to receive 500-mL bolus of intravenous crystalloid every 30 minutes to achieve central venous pressure of 8 to 12 mm Hg; vasopressors if mean arterial pressure less than 65 mm Hg; and vasodilators if mean arterial pressure is 90 mm Hg or above. Initiation and maintenance of therapeutic hypothermia, target core temperature of below 34°C via standard external cooling techniques. Percutaneous coronary intervention performed as soon as feasible in patients with ST elevation or left bundle branch block on initial ECG. Serum biochemistry (including sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate) monitored every 6 hours.; Device: High Volume Hemofiltration; Patients allocated to high volume HF will receive HF at 250 mL/h blood flow rate and 90 mL/kg/h ultrafiltration rate for 48 hours. All other care will be identical to that provided in the low volume HF group. Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused into the bloodstream before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution will be used. HF 1400 (i.e. polysulfone -based membrane) filters will be used throughout the study. The hemofilter will be changed every 6 h after initiation of HF, and otherwise as required.

Outcome Measures

Primary Outcome Measures

1. Intervention Compliance [48 hours]

   Intervention Compliance will be defined as the proportion of intervention patients who are alive and undergo hemofiltration (HF) for at least 80% of 48 hours from randomization.

Secondary Outcome Measures

1. Enrollment [12 hours]

   This will be defined as the proportion of eligible patients who are randomized.

2. Clearance of Inflammatory Mediators [48 hours]

   Venous blood samples will be obtained periodically after randomization, processed, stored, then tested for serum cytokine levels.

3. Total Volume Intravenous Fluid Infused [48 hours]

   This will be defined as the volume of fluid (in mL) infused during the first 48 hours from enrollment.

4. Use of Pressors and Inotropes [48 hours]

   This includes use of dopamine, dobutamine, epinephrine, nesiritide, norepinephrine, or phenylephrine during the first 48 hours from enrollment.

5. Shock [48 hours]

   This will be defined as systolic blood pressure < 65 at the end of any four hour period during the initial 48 hours of enrollment in control and intervention patients.

6. Ejection Fraction [48 hours]

   This will be assessed by standard transthoracic echocardiographic methods 48 hours after enrollment in control and intervention patients

7. Number of Hospital Days [6 months]

   This will be described for all hospitalized patients as a measure of morbidity after resuscitation.

8. Time Interval From 911 Call to Patient Death [1 year]

   This will be described for all hospitalized patients as a measure of morbidity after resuscitation.

9. Expected Adverse Event [48 hours]

   Device-Related Hematoma at insertion site, vessel perforation, wound infection, deep venous thrombosis or pulmonary embolism. Device Failure Mechanical failure Hypertension- SBP>160 mmHg, or DBP >120 mmHg. Hypotension- SBP<60 mmHg. Hypervolemia- CVP > 12 cm. Hypovolemia- CVP < 2 cm. Hypokalemia- serum potassium concentration < 3.5 mmol/L. Alkalosis- serum bicarbonate > 32 mmol/L. Hyperglycemia- serum glucose > 240 mg/dL. Hypophosphatemia- serum phosphate concentration < 0.8 mmol/L. Hypocalcemia- serum ionized calcium < 2.2 mmol/L. Lactic acidosis- serum lactate > 6 mmol/L.

10. Safety Outcome, Number of Participants With STEMI, Radiographic Pulmonary Edema, or Arrhythmia [48 hours]

    ST-Elevation Myocardial Infarction- ECG criteria and biomarker criteria for acute infarction. Radiographic Pulmonary Edema- radiographic presence of alveolar or interstitial edema, bilateral pleural effusions, cardiomegaly or venous congestion. Arrhythmia- other than sinus rhythm observed after randomization. Arrhythmia requiring treatment- rhythm with subsequent use of an antiarrhythmic drug or electrical therapy observed after randomization. Arrhythmia with cardiovascular instability- any rhythm with cardiovascular instability as determined by the DSMB, observed after randomization.

11. Unexpected Adverse Device Events (UADE) [48 hours]

    These will be defined as any unexpected adverse effect on health or safety or any unexpected life-threatening problem caused by, or associated with, a device, if that effect or problem was not previously identified in nature, severity, or degree of incidence in this investigation plan or application which will be submitted to the Food and Drug Administration (including a supplementary plan or application), or any other unexpected serious problem associated with a device. The death or neurological impairment of an individual patient will not be considered an adverse event in this study.

12. Clinical Safety Outcomes; Number of Participants With Clinical Diagnoses [Discharge]

    Clinical diagnoses of cerebral bleeding, stroke, bleeding requiring transfusion or surgical intervention, rearrest, pulmonary edema, rib or sternal fractures, internal thoracic or abdominal injuries as noted in the discharge summary

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• adults

• restoration of spontaneous circulation sustained to hospital arrival after OOHCA with any first recorded rhythm

• aged >=65 years

• less than 1 h from call to 911 until emergency department arrival

• less than 6 h from arrival until randomization

• informed consent provided by legally-authorized representative

Exclusion Criteria:

• do not attempt resuscitation orders; known end-stage terminal illness pre-arrest; major pre-arrest neurological dysfunction; another reason to be comatose (e.g. drug overdose)

• chronic steroid use

• non-English speaking LAR

• previous enrollment in the trial

• blunt, penetrating, or burn-related injury; exsanguination; drowning, electrocution or strangulation

• known pregnancy

• known prisoner

• weight > 100 kg

• persistent (i.e. 30 minutes) SBP< 80 mmHg despite pressors; refractory ventricular arrhythmias; severe bradycardia without a pacemaker

• thrombocytopenia (i.e. < 50,000/microL) or coagulopathy (i.e. INR > 1.5) or inferior vena cava filter in situ

• known cirrhosis

• serum ionized calcium < 2.2 mmol/L serum lactate > 6 mmol/L

• obeying verbal commands

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Harborview Medical Center	Seattle	Washington	United States	98040

Sponsors and Collaborators

• University of Washington

Investigators

• Principal Investigator: Graham Nichol, MD, University of Washington

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Graham Nichol, Professor, University of Washington
• ClinicalTrials.gov Identifier: NCT01509040
• Other Study ID Numbers: WASH CARDIAC
• First Posted: Jan 12, 2012
• Last Update Posted: Jun 9, 2016
• Last Verified: Jun 1, 2016

• Keywords provided by Graham Nichol, Professor, University of Washington: Resuscitated from Out-of-Hospital Cardiac Arrest
• Additional relevant MeSH terms: Heart Arrest; Out-of-Hospital Cardiac Arrest

Study Results

Participant Flow

Arm/Group Title	Control	Low Volume Hemofiltration	High Volume Hemofiltration
Arm/Group Description	Control group: Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious via standard external cooling techniques. Fluids, 500-mL bolus of intravenous crystalloid every 30 minutes to achieve a central venous pressure of 8 to 12 mm Hg; inotropes, vasopressors if mean arterial pressure is less than 65 mm Hg; vasodilators, if mean arterial pressure is 90 mm Hg or above to maintain hemodynamics. Percutaneous coronary intervention performed as soon as feasible in patients with ST elevation or left bundle branch block on initial ECG. Serum biochemistry (including sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate) monitored every 6 hours.	Low Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h. Low Volume Hemofiltration: Patients will receive isovolemic HF. Initial replacement solution will be Prismasol BGK4/2.5. 3.1mg/dL phosphate (1.0 mmol/L) added to each bag. Replacement fluid adjusted as required based on chemistry values for sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate. Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution used. HF 1400 (i.e. polysulfone -based membrane) filters used throughout study. Hemofilter changed every 6 h after initiation of HF, and as required.	High Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/kg/h, ultrafiltration 90 mL/kg/h. . High Volume Hemofiltration: Patients allocated to high volume HF will receive HF at 250 mL/h blood flow rate and 90 mL/kg/h ultrafiltration rate for 48 hours. All other care will be identical to that provided in the low volume HF group. Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused into the bloodstream before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution will be used. HF 1400 (i.e. polysulfone -based membrane) filters will be used throughout the study. The hemofilter will be changed every 6 h after initiation of HF, and otherwise as required.
Period Title: Overall Study
STARTED	0	2	0
COMPLETED	0	1	0
NOT COMPLETED	0	1	0

Baseline Characteristics

Arm/Group Title	Control	Low Volume Hemofiltration	High Volume Hemofiltration	Total
Arm/Group Description	Control group: Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious via standard external cooling techniques. Fluids, 500-mL bolus of intravenous crystalloid every 30 minutes to achieve a central venous pressure of 8 to 12 mm Hg; inotropes, vasopressors if mean arterial pressure is less than 65 mm Hg; vasodilators, if mean arterial pressure is 90 mm Hg or above to maintain hemodynamics. Percutaneous coronary intervention performed as soon as feasible in patients with ST elevation or left bundle branch block on initial ECG. Serum biochemistry (including sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate) monitored every 6 hours.	Low Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h. Low Volume Hemofiltration: Patients will receive isovolemic HF. Initial replacement solution will be Prismasol BGK4/2.5. 3.1mg/dL phosphate (1.0 mmol/L) added to each bag. Replacement fluid adjusted as required based on chemistry values for sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate. Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution used. HF 1400 (i.e. polysulfone -based membrane) filters used throughout study. Hemofilter changed every 6 h after initiation of HF, and as required.	High volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/kg/h, ultrafiltration 90 mL/kg/h. . High Volume Hemofiltration: Patients allocated to high volume HF will receive HF at 250 mL/h blood flow rate and 90 mL/kg/h ultrafiltration rate for 48 hours. All other care will be identical to that provided in the low volume HF group. Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused into the bloodstream before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution will be used. HF 1400 (i.e. polysulfone -based membrane) filters will be used throughout the study. The hemofilter will be changed every 6 h after initiation of HF, and otherwise as required.	Total of all reporting groups
Overall Participants	0	2	0	2
Age (participants) [Number]
<=18 years	0 NaN	0 0%
Between 18 and 65 years	0 NaN	0 0%
>=65 years	2 Infinity	2 100%
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	67	67
Gender (participants) [Number]
Female	1 Infinity	1 50%
Male	1 Infinity	1 50%
Region of Enrollment (participants) [Number]
United States	2 Infinity	2 100%

Outcome Measures

1. Primary Outcome

Title	Intervention Compliance
Description	Intervention Compliance will be defined as the proportion of intervention patients who are alive and undergo hemofiltration (HF) for at least 80% of 48 hours from randomization.
Time Frame	48 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	Low Volume Hemofiltration	High Volume Hemofiltration
Arm/Group Description	Control group: Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious via standard external cooling techniques. Fluids, 500-mL bolus of intravenous crystalloid every 30 minutes to achieve a central venous pressure of 8 to 12 mm Hg; inotropes, vasopressors if mean arterial pressure is less than 65 mm Hg; vasodilators, if mean arterial pressure is 90 mm Hg or above to maintain hemodynamics. Percutaneous coronary intervention performed as soon as feasible in patients with ST elevation or left bundle branch block on initial ECG. Serum biochemistry (including sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate) monitored every 6 hours.	Low Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h. Low Volume Hemofiltration: Patients will receive isovolemic HF. Initial replacement solution will be Prismasol BGK4/2.5. 3.1mg/dL phosphate (1.0 mmol/L) added to each bag. Replacement fluid adjusted as required based on chemistry values for sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate. Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution used. HF 1400 (i.e. polysulfone -based membrane) filters used throughout study. Hemofilter changed every 6 h after initiation of HF, and as required.	High volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/kg/h, ultrafiltration 90 mL/kg/h. . High Volume Hemofiltration: Patients allocated to high volume HF will receive HF at 250 mL/h blood flow rate and 90 mL/kg/h ultrafiltration rate for 48 hours. All other care will be identical to that provided in the low volume HF group. Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused into the bloodstream before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution will be used. HF 1400 (i.e. polysulfone -based membrane) filters will be used throughout the study. The hemofilter will be changed every 6 h after initiation of HF, and otherwise as required.
Measure Participants	0	2	0
Number [participants]	1 Infinity

2. Secondary Outcome

Title	Enrollment
Description	This will be defined as the proportion of eligible patients who are randomized.
Time Frame	12 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	Low Volume Hemofiltration	High Volume Hemofiltration
Arm/Group Description	Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious. Fluids, 500-mL bolus of intravenous crystalloid given every 30 minutes to achieve a central venous pressure of 8 to 12 mm Hg; inotropes, vasopressors if mean arterial pressure is less than 65 mm Hg; vasodilators, if mean arterial pressure is 90 mm Hg or above to maintain hemodynamics. Standard Care: Triple-lumen central venous catheter inserted for pressure monitoring. All patients to receive 500-mL bolus of intravenous crystalloid every 30 minutes to achieve central venous pressure of 8 to 12 mm Hg; vasopressors if mean arterial pressure less than 65 mm Hg; and vasodilators if mean arterial pressure is 90 mm Hg or above. Initiation and maintenance of therapeutic hypothermia, target core temperature of below 34°C via standard external cooling techniques. Percutaneous coronary intervention performed as	Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h. Fluids, 500-mL bolus of intravenous crystalloid given every 30 minutes to achieve a central venous pressure of 8 to 12 mm Hg; inotropes, vasopressors if mean arterial pressure is less than 65 mm Hg; vasodilators, if mean arterial pressure is 90 mm Hg or above to maintain hemodynamics. Standard Care: Triple-lumen central venous catheter inserted for pressure monitoring. All patients to receive 500-mL bolus of intravenous crystalloid every 30 minutes to achieve central venous pressure of 8 to 12 mm Hg; vasopressors if mean arterial pressure less than 65 mm Hg; and vasodilators if mean arterial pressure is 90 mm Hg or above. Initiation and maintenance of therapeutic hypothermia, target core tem	Initiate standard post-resuscitative care including a triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/kg/h, ultrafiltration 90 mL/kg/h. Fluids, 500-mL bolus of intravenous crystalloid given every 30 minutes to achieve a central venous pressure of 8 to 12 mm Hg; inotropes, vasopressors if mean arterial pressure is less than 65 mm Hg; vasodilators, if mean arterial pressure is 90 mm Hg or above to maintain hemodynamics. Standard Care: Triple-lumen central venous catheter inserted for pressure monitoring. All patients to receive 500-mL bolus of intravenous crystalloid every 30 minutes to achieve central venous pressure of 8 to 12 mm Hg; vasopressors if mean arterial pressure less than 65 mm Hg; and vasodilators if mean arterial pressure is 90 mm Hg or above. Initiation and maintenance of therapeutic hypothermia, target core
Measure Participants	0	2	0
Number [participants]	2 Infinity

3. Secondary Outcome

Title	Clearance of Inflammatory Mediators
Description	Venous blood samples will be obtained periodically after randomization, processed, stored, then tested for serum cytokine levels.
Time Frame	48 hours

Outcome Measure Data

Analysis Population Description

The outcome was not assessed.

Arm/Group Title	Control	Low Volume Hemofiltration	High Volume Hemofiltration
Arm/Group Description	Control group: Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious via standard external cooling techniques. Fluids, 500-mL bolus of intravenous crystalloid every 30 minutes to achieve a central venous pressure of 8 to 12 mmHg; inotropes, vasopressors if mean arterial pressure is less than 65 mmHg; vasodilators, if mean arterial pressure is 90 mmHg or above to maintain hemodynamics. Percutaneous coronary intervention performed as soon as feasible in patients with ST elevation or left bundle branch block on initial ECG. Serum biochemistry (including sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate) monitored every 6 hours.	Low Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h. Low Volume Hemofiltration: Patients will receive isovolemic HF. Initial replacement solution will be Prismasol BGK 4/2.5. 3.1mg/dL phosphate (1.0 mmol/L) added to each bag. Replacement fluid adjusted as required based on chemistry values for sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate. Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution used. HF 1400 (i.e. polysulfone-based membrane) filters used throughout study. Hemofilter changed every 6h after initiation of HF, and as required.	High Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 90 mL/kg/h. HIgh Volume Hemofiltration: Patients allocated to high volume HF will receive HF at 250 mL/h blood flow rate and 90 mL/kg/h ultrafiltration rate for 48 hours. All other care will be identical to that provided in the low volume HF group. Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused into the bloodstream before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution will be used. HF 1400 (i.e. polysulfone-based membrane) filters used throughout study. Hemofilter changed every 6h after initiation of HF, and as required.
Measure Participants	0	0	0

4. Secondary Outcome

Title	Total Volume Intravenous Fluid Infused
Description	This will be defined as the volume of fluid (in mL) infused during the first 48 hours from enrollment.
Time Frame	48 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	Low Volume Hemofiltration	High Volume Hemofiltration
Arm/Group Description	Control group: Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious via standard external cooling techniques. Fluids, 500-mL bolus of intravenous crystalloid every 30 minutes to achieve a central venous pressure of 8 to 12 mmHg; inotropes, vasopressors if mean arterial pressure is less than 65 mmHg; vasodilators, if mean arterial pressure is 90 mmHg or above to maintain hemodynamics. Percutaneous coronary intervention performed as soon as feasible in patients with ST elevation or left bundle branch block on initial ECG. Serum biochemistry (including sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate) monitored every 6 hours.	Low Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h. Low Volume Hemofiltration: Patients will receive isovolemic HF. Initial replacement solution will be Prismasol BGK 4/2.5. 3.1mg/dL phosphate (1.0 mmol/L) added to each bag. Replacement fluid adjusted as required based on chemistry values for sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate. Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution used. HF 1400 (i.e. polysulfone-based membrane) filters used throughout study. Hemofilter changed every 6h after initiation of HF, and as required.	High Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 90 mL/kg/h. HIgh Volume Hemofiltration: Patients allocated to high volume HF will receive HF at 250 mL/h blood flow rate and 90 mL/kg/h ultrafiltration rate for 48 hours. All other care will be identical to that provided in the low volume HF group. Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused into the bloodstream before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution will be used. HF 1400 (i.e. polysulfone-based membrane) filters used throughout study. Hemofilter changed every 6h after initiation of HF, and as required.
Measure Participants	0	2	0
Mean (Inter-Quartile Range) [mL]	10652.5

5. Secondary Outcome

Title	Use of Pressors and Inotropes
Description	This includes use of dopamine, dobutamine, epinephrine, nesiritide, norepinephrine, or phenylephrine during the first 48 hours from enrollment.
Time Frame	48 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	Low Volume Hemofiltration	High Volume Hemofiltration
Arm/Group Description	Control group: Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious via standard external cooling techniques. Fluids, 500-mL bolus of intravenous crystalloid every 30 minutes to achieve a central venous pressure of 8 to 12 mmHg; inotropes, vasopressors if mean arterial pressure is less than 65 mmHg; vasodilators, if mean arterial pressure is 90 mmHg or above to maintain hemodynamics. Percutaneous coronary intervention performed as soon as feasible in patients with ST elevation or left bundle branch block on initial ECG. Serum biochemistry (including sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate) monitored every 6 hours.	Low Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h. Low Volume Hemofiltration: Patients will receive isovolemic HF. Initial replacement solution will be Prismasol BGK 4/2.5. 3.1mg/dL phosphate (1.0 mmol/L) added to each bag. Replacement fluid adjusted as required based on chemistry values for sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate. Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution used. HF 1400 (i.e. polysulfone-based membrane) filters used throughout study. Hemofilter changed every 6h after initiation of HF, and as required.	High Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 90 mL/kg/h. HIgh Volume Hemofiltration: Patients allocated to high volume HF will receive HF at 250 mL/h blood flow rate and 90 mL/kg/h ultrafiltration rate for 48 hours. All other care will be identical to that provided in the low volume HF group. Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused into the bloodstream before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution will be used. HF 1400 (i.e. polysulfone-based membrane) filters used throughout study. Hemofilter changed every 6h after initiation of HF, and as required.
Measure Participants	0	2	0
Number [participants]	1 Infinity

6. Secondary Outcome

Title	Shock
Description	This will be defined as systolic blood pressure < 65 at the end of any four hour period during the initial 48 hours of enrollment in control and intervention patients.
Time Frame	48 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	Low Volume Hemofiltration	High Volume Hemofiltration
Arm/Group Description	Control group: Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious via standard external cooling techniques. Fluids, 500-mL bolus of intravenous crystalloid every 30 minutes to achieve a central venous pressure of 8 to 12 mmHg; inotropes, vasopressors if mean arterial pressure is less than 65 mmHg; vasodilators, if mean arterial pressure is 90 mmHg or above to maintain hemodynamics. Percutaneous coronary intervention performed as soon as feasible in patients with ST elevation or left bundle branch block on initial ECG. Serum biochemistry (including sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate) monitored every 6 hours.	Low Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h. Low Volume Hemofiltration: Patients will receive isovolemic HF. Initial replacement solution will be Prismasol BGK 4/2.5. 3.1mg/dL phosphate (1.0 mmol/L) added to each bag. Replacement fluid adjusted as required based on chemistry values for sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate. Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution used. HF 1400 (i.e. polysulfone-based membrane) filters used throughout study. Hemofilter changed every 6h after initiation of HF, and as required.	High Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 90 mL/kg/h. HIgh Volume Hemofiltration: Patients allocated to high volume HF will receive HF at 250 mL/h blood flow rate and 90 mL/kg/h ultrafiltration rate for 48 hours. All other care will be identical to that provided in the low volume HF group. Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused into the bloodstream before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution will be used. HF 1400 (i.e. polysulfone-based membrane) filters used throughout study. Hemofilter changed every 6h after initiation of HF, and as required.
Measure Participants	0	2	0
Number [participants]	0 NaN

7. Secondary Outcome

Title	Ejection Fraction
Description	This will be assessed by standard transthoracic echocardiographic methods 48 hours after enrollment in control and intervention patients
Time Frame	48 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	Low Volume Hemofiltration	High Volume Hemofiltration
Arm/Group Description	Control group: Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious via standard external cooling techniques. Fluids, 500-mL bolus of intravenous crystalloid every 30 minutes to achieve a central venous pressure of 8 to 12 mmHg; inotropes, vasopressors if mean arterial pressure is less than 65 mmHg; vasodilators, if mean arterial pressure is 90 mmHg or above to maintain hemodynamics. Percutaneous coronary intervention performed as soon as feasible in patients with ST elevation or left bundle branch block on initial ECG. Serum biochemistry (including sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate) monitored every 6 hours.	Low Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h. Low Volume Hemofiltration: Patients will receive isovolemic HF. Initial replacement solution will be Prismasol BGK 4/2.5. 3.1mg/dL phosphate (1.0 mmol/L) added to each bag. Replacement fluid adjusted as required based on chemistry values for sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate. Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution used. HF 1400 (i.e. polysulfone-based membrane) filters used throughout study. Hemofilter changed every 6h after initiation of HF, and as required.	High Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 90 mL/kg/h. HIgh Volume Hemofiltration: Patients allocated to high volume HF will receive HF at 250 mL/h blood flow rate and 90 mL/kg/h ultrafiltration rate for 48 hours. All other care will be identical to that provided in the low volume HF group. Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused into the bloodstream before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution will be used. HF 1400 (i.e. polysulfone-based membrane) filters used throughout study. Hemofilter changed every 6h after initiation of HF, and as required.
Measure Participants	0	2	0
Mean (Inter-Quartile Range) [percentage]	65

8. Secondary Outcome

Title	Number of Hospital Days
Description	This will be described for all hospitalized patients as a measure of morbidity after resuscitation.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	Low Volume Hemofiltration	High Volume Hemofiltration
Arm/Group Description	Control group: Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious via standard external cooling techniques. Fluids, 500-mL bolus of intravenous crystalloid every 30 minutes to achieve a central venous pressure of 8 to 12 mm Hg; inotropes, vasopressors if mean arterial pressure is less than 65 mm Hg; vasodilators, if mean arterial pressure is 90 mm Hg or above to maintain hemodynamics. Percutaneous coronary intervention performed as soon as feasible in patients with ST elevation or left bundle branch block on initial ECG. Serum biochemistry (including sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate) monitored every 6 hours.	Low Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h. Low Volume Hemofiltration: Patients will receive isovolemic HF. Initial replacement solution will be Prismasol BGK4/2.5. 3.1mg/dL phosphate (1.0 mmol/L) added to each bag. Replacement fluid adjusted as required based on chemistry values for sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate. Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution used. HF 1400 (i.e. polysulfone -based membrane) filters used throughout study. Hemofilter changed every 6 h after initiation of HF, and as required.	High Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/kg/h, ultrafiltration 90 mL/kg/h. . High Volume Hemofiltration: Patients allocated to high volume HF will receive HF at 250 mL/h blood flow rate and 90 mL/kg/h ultrafiltration rate for 48 hours. All other care will be identical to that provided in the low volume HF group. Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused into the bloodstream before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution will be used. HF 1400 (i.e. polysulfone -based membrane) filters will be used throughout the study. The hemofilter will be changed every 6 h after initiation of HF, and otherwise as required.
Measure Participants	0	2	0
Mean (Inter-Quartile Range) [days]	8.5

9. Secondary Outcome

Title	Time Interval From 911 Call to Patient Death
Description	This will be described for all hospitalized patients as a measure of morbidity after resuscitation.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	Low Volume Hemofiltration	High Volume Hemofiltration
Arm/Group Description	Control group: Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious via standard external cooling techniques. Fluids, 500-mL bolus of intravenous crystalloid every 30 minutes to achieve a central venous pressure of 8 to 12 mmHg; inotropes, vasopressors if mean arterial pressure is less than 65 mmHg; vasodilators, if mean arterial pressure is 90 mmHg or above to maintain hemodynamics. Percutaneous coronary intervention performed as soon as feasible in patients with ST elevation or left bundle branch block on initial ECG. Serum biochemistry (including sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate) monitored every 6 hours.	Low Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h. Low Volume Hemofiltration: Patients will receive isovolemic HF. Initial replacement solution will be Prismasol BGK 4/2.5. 3.1mg/dL phosphate (1.0 mmol/L) added to each bag. Replacement fluid adjusted as required based on chemistry values for sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate. Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution used. HF 1400 (i.e. polysulfone-based membrane) filters used throughout study. Hemofilter changed every 6h after initiation of HF, and as required.	High Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 90 mL/kg/h. HIgh Volume Hemofiltration: Patients allocated to high volume HF will receive HF at 250 mL/h blood flow rate and 90 mL/kg/h ultrafiltration rate for 48 hours. All other care will be identical to that provided in the low volume HF group. Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused into the bloodstream before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution will be used. HF 1400 (i.e. polysulfone-based membrane) filters used throughout study. Hemofilter changed every 6h after initiation of HF, and as required.
Measure Participants	0	2	0
Mean (Inter-Quartile Range) [Days]	183.6

10. Secondary Outcome

Title	Expected Adverse Event
Description	Device-Related Hematoma at insertion site, vessel perforation, wound infection, deep venous thrombosis or pulmonary embolism. Device Failure Mechanical failure Hypertension- SBP>160 mmHg, or DBP >120 mmHg. Hypotension- SBP<60 mmHg. Hypervolemia- CVP > 12 cm. Hypovolemia- CVP < 2 cm. Hypokalemia- serum potassium concentration < 3.5 mmol/L. Alkalosis- serum bicarbonate > 32 mmol/L. Hyperglycemia- serum glucose > 240 mg/dL. Hypophosphatemia- serum phosphate concentration < 0.8 mmol/L. Hypocalcemia- serum ionized calcium < 2.2 mmol/L. Lactic acidosis- serum lactate > 6 mmol/L.
Time Frame	48 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	Low Volume Hemofiltration	High Volume Hemofiltration
Arm/Group Description	Control group: Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious via standard external cooling techniques. Fluids, 500-mL bolus of intravenous crystalloid every 30 minutes to achieve a central venous pressure of 8 to 12 mmHg; inotropes, vasopressors if mean arterial pressure is less than 65 mmHg; vasodilators, if mean arterial pressure is 90 mmHg or above to maintain hemodynamics. Percutaneous coronary intervention performed as soon as feasible in patients with ST elevation or left bundle branch block on initial ECG. Serum biochemistry (including sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate) monitored every 6 hours.	Low Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h. Low Volume Hemofiltration: Patients will receive isovolemic HF. Initial replacement solution will be Prismasol BGK 4/2.5. 3.1mg/dL phosphate (1.0 mmol/L) added to each bag. Replacement fluid adjusted as required based on chemistry values for sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate. Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution used. HF 1400 (i.e. polysulfone-based membrane) filters used throughout study. Hemofilter changed every 6h after initiation of HF, and as required.	High Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 90 mL/kg/h. HIgh Volume Hemofiltration: Patients allocated to high volume HF will receive HF at 250 mL/h blood flow rate and 90 mL/kg/h ultrafiltration rate for 48 hours. All other care will be identical to that provided in the low volume HF group. Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused into the bloodstream before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution will be used. HF 1400 (i.e. polysulfone-based membrane) filters used throughout study. Hemofilter changed every 6h after initiation of HF, and as required.
Measure Participants	0	2	0
Number [participants]	2 Infinity

11. Secondary Outcome

Title	Safety Outcome, Number of Participants With STEMI, Radiographic Pulmonary Edema, or Arrhythmia
Description	ST-Elevation Myocardial Infarction- ECG criteria and biomarker criteria for acute infarction. Radiographic Pulmonary Edema- radiographic presence of alveolar or interstitial edema, bilateral pleural effusions, cardiomegaly or venous congestion. Arrhythmia- other than sinus rhythm observed after randomization. Arrhythmia requiring treatment- rhythm with subsequent use of an antiarrhythmic drug or electrical therapy observed after randomization. Arrhythmia with cardiovascular instability- any rhythm with cardiovascular instability as determined by the DSMB, observed after randomization.
Time Frame	48 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	Low Volume Hemofiltration	High Volume Hemofiltration
Arm/Group Description	Control group: Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious via standard external cooling techniques. Fluids, 500-mL bolus of intravenous crystalloid every 30 minutes to achieve a central venous pressure of 8 to 12 mm Hg; inotropes, vasopressors if mean arterial pressure is less than 65 mm Hg; vasodilators, if mean arterial pressure is 90 mm Hg or above to maintain hemodynamics. Percutaneous coronary intervention performed as soon as feasible in patients with ST elevation or left bundle branch block on initial ECG. Serum biochemistry (including sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate) monitored every 6 hours.	Low Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h. Low Volume Hemofiltration: Patients will receive isovolemic HF. Initial replacement solution will be Prismasol BGK4/2.5. 3.1mg/dL phosphate (1.0 mmol/L) added to each bag. Replacement fluid adjusted as required based on chemistry values for sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate. Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution used. HF 1400 (i.e. polysulfone -based membrane) filters used throughout study. Hemofilter changed every 6 h after initiation of HF, and as required.	High volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/kg/h, ultrafiltration 90 mL/kg/h. . High Volume Hemofiltration: Patients allocated to high volume HF will receive HF at 250 mL/h blood flow rate and 90 mL/kg/h ultrafiltration rate for 48 hours. All other care will be identical to that provided in the low volume HF group. Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused into the bloodstream before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution will be used. HF 1400 (i.e. polysulfone -based membrane) filters will be used throughout the study. The hemofilter will be changed every 6 h after initiation of HF, and otherwise as required.
Measure Participants	0	2	0
Number [Participant]	2

12. Secondary Outcome

Title	Unexpected Adverse Device Events (UADE)
Description	These will be defined as any unexpected adverse effect on health or safety or any unexpected life-threatening problem caused by, or associated with, a device, if that effect or problem was not previously identified in nature, severity, or degree of incidence in this investigation plan or application which will be submitted to the Food and Drug Administration (including a supplementary plan or application), or any other unexpected serious problem associated with a device. The death or neurological impairment of an individual patient will not be considered an adverse event in this study.
Time Frame	48 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	Low Volume Hemofiltration	High Volume Hemofiltration
Arm/Group Description	Control group: Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious via standard external cooling techniques. Fluids, 500-mL bolus of intravenous crystalloid every 30 minutes to achieve a central venous pressure of 8 to 12 mmHg; inotropes, vasopressors if mean arterial pressure is less than 65 mmHg; vasodilators, if mean arterial pressure is 90 mmHg or above to maintain hemodynamics. Percutaneous coronary intervention performed as soon as feasible in patients with ST elevation or left bundle branch block on initial ECG. Serum biochemistry (including sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate) monitored every 6 hours.	Low Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h. Low Volume Hemofiltration: Patients will receive isovolemic HF. Initial replacement solution will be Prismasol BGK 4/2.5. 3.1mg/dL phosphate (1.0 mmol/L) added to each bag. Replacement fluid adjusted as required based on chemistry values for sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate. Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution used. HF 1400 (i.e. polysulfone-based membrane) filters used throughout study. Hemofilter changed every 6h after initiation of HF, and as required.	High Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 90 mL/kg/h. HIgh Volume Hemofiltration: Patients allocated to high volume HF will receive HF at 250 mL/h blood flow rate and 90 mL/kg/h ultrafiltration rate for 48 hours. All other care will be identical to that provided in the low volume HF group. Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused into the bloodstream before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution will be used. HF 1400 (i.e. polysulfone-based membrane) filters used throughout study. Hemofilter changed every 6h after initiation of HF, and as required.
Measure Participants	0	2	0
Number [participants]	0 NaN

13. Secondary Outcome

Title	Clinical Safety Outcomes; Number of Participants With Clinical Diagnoses
Description	Clinical diagnoses of cerebral bleeding, stroke, bleeding requiring transfusion or surgical intervention, rearrest, pulmonary edema, rib or sternal fractures, internal thoracic or abdominal injuries as noted in the discharge summary
Time Frame	Discharge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	Low Volume Hemofiltration	High Volume Hemofiltration
Arm/Group Description	Control group: Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious via standard external cooling techniques. Fluids, 500-mL bolus of intravenous crystalloid every 30 minutes to achieve a central venous pressure of 8 to 12 mmHg; inotropes, vasopressors if mean arterial pressure is less than 65 mmHg; vasodilators, if mean arterial pressure is 90 mmHg or above to maintain hemodynamics. Percutaneous coronary intervention performed as soon as feasible in patients with ST elevation or left bundle branch block on initial ECG. Serum biochemistry (including sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate) monitored every 6 hours.	Low Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h. Low Volume Hemofiltration: Patients will receive isovolemic HF. Initial replacement solution will be Prismasol BGK 4/2.5. 3.1mg/dL phosphate (1.0 mmol/L) added to each bag. Replacement fluid adjusted as required based on chemistry values for sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate. Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution used. HF 1400 (i.e. polysulfone-based membrane) filters used throughout study. Hemofilter changed every 6h after initiation of HF, and as required.	High Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 90 mL/kg/h. HIgh Volume Hemofiltration: Patients allocated to high volume HF will receive HF at 250 mL/h blood flow rate and 90 mL/kg/h ultrafiltration rate for 48 hours. All other care will be identical to that provided in the low volume HF group. Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused into the bloodstream before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution will be used. HF 1400 (i.e. polysulfone-based membrane) filters used throughout study. Hemofilter changed every 6h after initiation of HF, and as required.
Measure Participants	0	2	0
Number [participants]	2 Infinity

Adverse Events

Arm/Group Title	Control		Low Volume Hemofiltration		High Volume Hemofiltration
Arm/Group Description	Control group: Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious via standard external cooling techniques. Fluids, 500-mL bolus of intravenous crystalloid every 30 minutes to achieve a central venous pressure of 8 to 12 mm Hg; inotropes, vasopressors if mean arterial pressure is less than 65 mm Hg; vasodilators, if mean arterial pressure is 90 mm Hg or above to maintain hemodynamics. Percutaneous coronary intervention performed as soon as feasible in patients with ST elevation or left bundle branch block on initial ECG. Serum biochemistry (including sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate) monitored every 6 hours.		Low Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h. Low Volume Hemofiltration: Patients will receive isovolemic HF. Initial replacement solution will be Prismasol BGK4/2.5. 3.1mg/dL phosphate (1.0 mmol/L) added to each bag. Replacement fluid adjusted as required based on chemistry values for sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate. Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution used. HF 1400 (i.e. polysulfone -based membrane) filters used throughout study. Hemofilter changed every 6 h after initiation of HF, and as required.		High volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/kg/h, ultrafiltration 90 mL/kg/h. . High Volume Hemofiltration: Patients allocated to high volume HF will receive HF at 250 mL/h blood flow rate and 90 mL/kg/h ultrafiltration rate for 48 hours. All other care will be identical to that provided in the low volume HF group. Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused into the bloodstream before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution will be used. HF 1400 (i.e. polysulfone -based membrane) filters will be used throughout the study. The hemofilter will be changed every 6 h after initiation of HF, and otherwise as required.
All Cause Mortality
	Control		Low Volume Hemofiltration		High Volume Hemofiltration
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Control		Low Volume Hemofiltration		High Volume Hemofiltration
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		1/2 (50%)		0/0 (NaN)
Cardiac disorders
Arrhythmia associated with cardiovascular instability	0/0 (NaN)		1/2 (50%)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Control		Low Volume Hemofiltration		High Volume Hemofiltration
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		1/2 (50%)		0/0 (NaN)
Cardiac disorders
Arrhythmia associated with low blood pressure	0/0 (NaN)		1/2 (50%)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.