Hemofiltration in Burns: RESCUE (Randomized Controlled Evaluation of Hemofiltration in Adult Burn Patients With Septic Shock and Acute Renal Failure)

Sponsor

American Burn Association (Other)

Overall Status

Unknown status

CT.gov ID

NCT01213914

Collaborator

United States Army Institute of Surgical Research (U.S. Fed), Tampa General Hospital (Other), Medstar Health Research Institute (Other), Loyola University (Other), University of Texas Southwestern Medical Center (Other), Valleywise Health (Other), University of Tennessee Health Science Center (Other), University of Kansas Medical Center (Other), Doctors Hospital-Joseph M Still Burn Center (Other)

Enrollment

Locations

Arms

Duration (Months)

4.1

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is determine if High-Volume Hemofiltration in addition to 'contemporary' care will result in an improvement of select clinical outcomes when compared to 'contemporary' care alone in the treatment of critically ill patients with ARF secondary to septic shock.

Condition or Disease	Intervention/Treatment	Phase
Burns Hemofiltration Kidney Failure, Acute Shock, Septic	Device: An FDA approved continuous renal replacement device Other: Control Group	N/A

Detailed Description

Acute renal failure (ARF) is a common and devastating complication in critically ill burn patients with mortality reported to be between 80 and 100%.(3-7) Despite recent advances in burn care, the unacceptably high mortality rate in this subgroup has not changed over time. The pathogenesis of ARF in burns, similar to other critically ill populations, is often multi-factorial with one major component being sepsis induced ischemic tubular necrosis. Thus, ARF secondary to septic shock is a common and devastating condition in the burn ICU.

Study Design

Study Type:

Interventional

Actual Enrollment :

37 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

The American Burn Association's Randomized Controlled Evaluation of Hemofiltration in Adult Burn Patients With Septic Shock and Acute Renal Failure

Study Start Date :

Aug 1, 2011

Anticipated Primary Completion Date :

Sep 1, 2018

Anticipated Study Completion Date :

Sep 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: High-volume hemofiltration at 70ml/kg/hr Paired randomization into four groups via central randomization center. Group 1: age 18-65 and <40%TBSA Group 2: age 18-65 and >40%TBSA Group 3: age >65 and <40%TBSA Group 4: age >65 and >40%TBSA	Device: An FDA approved continuous renal replacement device 70ml/kg/hr for treatment group for 48 hours with the following requirements: double lumen dialysis catheter should be placed in the internal jugular or femoral vein Anticoagulation will be determined by prescribing physician Use of 1.4 m2 or larger biocompatible synthetic hollow-fiber dialysis membrane that is changed every 24 hours Blood flow rate will be set to ensure a filtration fraction of no more than 25% Monitoring for electrolytes (specifically K+, Mg, Ca, and phos) during HVHF must be performed at least every 6 hours Replacement fluids will be bicarbonate-buffered with appropriate adjustments when citrate-anticoagulation is utilized All antibiotics will be dose adjusted for renal replacement therapy Other Names: High volume hemofiltration
Active Comparator: Control group Contemporary care via consideration of the Burn-Specific Sepsis Bundle adapted form the most recent Surviving Sepsis campaign recommendations and specifically modified to our patient population.	Other: Control Group Both groups will receive 'contemporary' care via consideration of the Burn-specific Sepsis Bundle adapted from the most recent Surviving Sepsis Campaign (SSC) (1) recommendations and specifically modified to our patient population Other Names: Standard of care

Arm

Intervention/Treatment

Experimental: High-volume hemofiltration at 70ml/kg/hr

Paired randomization into four groups via central randomization center. Group 1: age 18-65 and <40%TBSA Group 2: age 18-65 and >40%TBSA Group 3: age >65 and <40%TBSA Group 4: age >65 and >40%TBSA

Device: An FDA approved continuous renal replacement device

70ml/kg/hr for treatment group for 48 hours with the following requirements: double lumen dialysis catheter should be placed in the internal jugular or femoral vein Anticoagulation will be determined by prescribing physician Use of 1.4 m2 or larger biocompatible synthetic hollow-fiber dialysis membrane that is changed every 24 hours Blood flow rate will be set to ensure a filtration fraction of no more than 25% Monitoring for electrolytes (specifically K+, Mg, Ca, and phos) during HVHF must be performed at least every 6 hours Replacement fluids will be bicarbonate-buffered with appropriate adjustments when citrate-anticoagulation is utilized All antibiotics will be dose adjusted for renal replacement therapy

Other Names:

High volume hemofiltration

Active Comparator: Control group

Contemporary care via consideration of the Burn-Specific Sepsis Bundle adapted form the most recent Surviving Sepsis campaign recommendations and specifically modified to our patient population.

Other: Control Group

Both groups will receive 'contemporary' care via consideration of the Burn-specific Sepsis Bundle adapted from the most recent Surviving Sepsis Campaign (SSC) (1) recommendations and specifically modified to our patient population

Other Names:

Standard of care

Outcome Measures

Primary Outcome Measures

Vasopressor dependency index [first 48 hours]
Vasopressor dependency index = MAP/Inotropic score • This index will correct for the inter-center variability that exists with regards to the point (minimum MAP) at which vasopressors are initiated or weaned off. Thus, this eliminates the need to 'standardize' starting/stopping criteria of vasopressors. Modified Inotropic index (30) = (dopamine dose X1)+(dobutamine dose X1)+(epi doseX100)+(norepi doseX100)+(phenylephrine doseX100)+(vasopressin doseX100) • All units recorded at each time point in mcg/kg/min Mean Arterial Pressure (mmHg)

Secondary Outcome Measures

PaO2/FiO2 ratio and Oxygenation index [first 48 hours]
Vasopressors-free days [first 14 days]
Survival [14 days, 28 days, and discharge]
ICU days [Total number of days in ICU from date of Therapy Initiated through discharge]
Ventilator free days [First 28 days after enrollment]
Renal loss (need for long term renal replacement therapy) [greater than 28 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

All adult patients admitted to the burn intensive care unit (ICU) with burns of any size
Acute renal failure as previously defined by the Veterans Affairs/ National Institutes of Health (VA/NIH) Acute Renal Failure Trial Network study investigators(2)
Patient is > 48 hours post-burn and in Septic Shock
Patients 18 or older
Patient/legally authorized representative willing to provide consent

Exclusion Criteria:

Age <18
Non-thermal injury (exfoliating skin disorders or necrotizing fasciitis)
Pre-admission diagnosis of end stage renal failure
Patients already on renal replacement therapy for more than 24 hours
Patient not expected to survive more than 24 hours after randomization.
Pregnancy
Prisoners

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arizona Burn Center	Phoenix	Arizona	United States	85008
2	The Burn Center at Washington Hospital Center	Washington	District of Columbia	United States	20010
3	Tampa General Hospital	Tampa	Florida	United States	33606
4	Doctors Hospital-Joseph M Still Burn Center	Augusta	Georgia	United States	30909
5	Loyola University Medical Center	Maywood	Illinois	United States	60153
6	University of Kansas Hospital	Kansas City	Kansas	United States	66160
7	Regional Medical Center at Memphis	Memphis	Tennessee	United States	38103
8	University of Texas Southwestern Medical Center-Burn Center Parkland Health	Dallas	Texas	United States	75235
9	US Army Institute of Surgical Research	Fort Sam Houston	Texas	United States	78234