Goal-Directed Intraoperative Fluid Management Using FloTrac© Monitoring in High-Risk Neurosurgical Patients

• Sponsor: NYU Langone Health (Other)
• Overall Status: Completed
• CT.gov ID: NCT02701582
• Collaborator: (none)
• Enrollment: 66
• Location: 1
• Arms: 2
• Duration (Months): 30.1
• Patients Per Site Per Month: 2.2

Study Details

Study Description

Brief Summary

This is a prospective, randomized controlled trial to determine if using FloTrac/EV1000 system in neurosurgical patients undergoing craniotomies for aneurysm repair or tumor resection complicated by cerebral edema, or complex spinal surgery including multi-level scoliosis correction, is a more effective way of monitoring fluid.

Condition or Disease	Intervention/Treatment	Phase
Intracranial Aneurysm; Brain Edema; Scoliosis; Surgery	Drug: Phenylephrine; Drug: Epinephrine; Other: Albumin; Other: Voluven; Other: Normal Saline; Other: Packed Red Blood Cells; Device: FloTrac Monitor	N/A

Detailed Description

We hypothesize that the ability to assess volume status and fluid responsiveness with information gained from Edwards FloTrac/EV1000 system coupled with a goal-directed therapy fluid management algorithm can make a difference in patient outcomes. Our specific aims are:

• Demonstrate goal-directed therapy (GDT) in fluid management improves peri-operative fluid balance

• Demonstrate GDT improves pulmonary function and organ oxygenation

• Demonstrate GDT reduces necessary therapeutic interventions in the peri- operative period

• Demonstrate GDT reduces hypotensive episodes in the peri-operative period

Outcomes

We will study the consequences of goal-directed fluid therapy that employs use of dynamic indicators seen on FloTrac/EV1000 system by measuring the following:

• Pulmonary status

• Time to extubation

• Alveolar-arterial (A-a) gradient of oxygen

• Requirements for supplemental oxygen

• Organ oxygenation

• Serum lactate

• Arterial blood gas values (pH, HCO3, CO2, O2)

• Length of stay (LOS)

• In hospital, defined as time from operation start to eligibility for discharge from hospital according to surgeon in accordance with pre-define criteria

• In ICU/PACU, defined as time from operation end to eligibility for discharge from intensive care according to attending intensivist in accordance with pre- define criteria

• Fluid Balance

• Inputs and outputs (I/Os) of all measurable fluids (i.e. blood, crystalloid, colloid) in peri-operative period, through and including duration of intensive care or the next 24-48 hours after completion of surgery

• Drugs administered for fluid management (i.e. mannitol, vasopressors)

• Pre-operative and post-operative body weights and twice-daily weights via bed weights

• Hypotension

• Number, duration and severity (i.e. minimum blood pressure) of hypotensive episode, defined as MAP <65

Study Design

• Study Type: Interventional
• Actual Enrollment: 66 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Goal-Directed Intraoperative Fluid Management Using FloTrac© Monitoring in High-Risk Neurosurgical Patients
• Study Start Date: Mar 1, 2014
• Actual Primary Completion Date: Jan 1, 2016
• Actual Study Completion Date: Sep 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Goal Directed Therapy Flotrack monitor is connected and based on what anesthesiologist sees and following study algorithm, anesthesiologist chooses: Phenylephrine, Epinephrine , volume resuscitation (fluids, including normal saline, albumin, voluven and packed red blood cells) and no intervention.	Drug: Phenylephrine; if Mean arterial pressure (MAP) is < = 65, Stroke volume variation (SVV) < 13 and Cardiac Index is >=2.2 Phenylephrine is administered; Other Names: Sudafed Neo-Synephrine SudoGest ; Drug: Epinephrine; if Mean arterial pressure (MAP) is < = 65, Stroke volume variation (SVV) < 13 and Cardiac Index is < 2.2 Epinephrine is administered; Other Names: EpiPen Adrenaclick Medihaler-Epi ; Other: Albumin; if Mean arterial pressure (MAP) is < = 65, Stroke volume variation (SVV) > = 13, fluids are administered --OR-- if Mean arterial pressure (MAP) is > 65, Stroke volume variation (SVV) > = 13 and Cardiac Index is <2.2 fluids are administered.; Other: Voluven; if Mean arterial pressure (MAP) is < = 65, Stroke volume variation (SVV) > = 13, fluids are administered --OR-- if Mean arterial pressure (MAP) is > 65, Stroke volume variation (SVV) > = 13 and Cardiac Index is <2.2 fluids are administered.; Other: Normal Saline; if Mean arterial pressure (MAP) is < = 65, Stroke volume variation (SVV) > = 13, fluids are administered --OR-- if Mean arterial pressure (MAP) is > 65, Stroke volume variation (SVV) > = 13 and Cardiac Index is <2.2 fluids are administered.; Other: Packed Red Blood Cells; if Mean arterial pressure (MAP) is < = 65, Stroke volume variation (SVV) > = 13, fluids are administered --OR-- if Mean arterial pressure (MAP) is > 65, Stroke volume variation (SVV) > = 13 and Cardiac Index is <2.2 fluids are administered.; Device: FloTrac Monitor; FloTrac monitor is connected for all patients, but only visible to the anesthesiologist for half. Based on a decision tree and the data from monitor, choices of interventions are used.
Active Comparator: Control Group FloTrac monitor is connected, but he anesthesiologist will not be able to see the monitor although the data will be collected and stored for analysis. Anesthesiologist will be given a study algorithm to follow for the duration of the surgery, and based on it will choose: Phenylephrine, Epinephrine , volume resuscitation (fluids, including normal saline, albumin, voluven and packed red blood cells) and no intervention.	Drug: Phenylephrine; if Mean arterial pressure (MAP) is < = 65, Stroke volume variation (SVV) < 13 and Cardiac Index is >=2.2 Phenylephrine is administered; Other Names: Sudafed Neo-Synephrine SudoGest ; Drug: Epinephrine; if Mean arterial pressure (MAP) is < = 65, Stroke volume variation (SVV) < 13 and Cardiac Index is < 2.2 Epinephrine is administered; Other Names: EpiPen Adrenaclick Medihaler-Epi ; Other: Albumin; if Mean arterial pressure (MAP) is < = 65, Stroke volume variation (SVV) > = 13, fluids are administered --OR-- if Mean arterial pressure (MAP) is > 65, Stroke volume variation (SVV) > = 13 and Cardiac Index is <2.2 fluids are administered.; Other: Voluven; if Mean arterial pressure (MAP) is < = 65, Stroke volume variation (SVV) > = 13, fluids are administered --OR-- if Mean arterial pressure (MAP) is > 65, Stroke volume variation (SVV) > = 13 and Cardiac Index is <2.2 fluids are administered.; Other: Normal Saline; if Mean arterial pressure (MAP) is < = 65, Stroke volume variation (SVV) > = 13, fluids are administered --OR-- if Mean arterial pressure (MAP) is > 65, Stroke volume variation (SVV) > = 13 and Cardiac Index is <2.2 fluids are administered.; Other: Packed Red Blood Cells; if Mean arterial pressure (MAP) is < = 65, Stroke volume variation (SVV) > = 13, fluids are administered --OR-- if Mean arterial pressure (MAP) is > 65, Stroke volume variation (SVV) > = 13 and Cardiac Index is <2.2 fluids are administered.; Device: FloTrac Monitor; FloTrac monitor is connected for all patients, but only visible to the anesthesiologist for half. Based on a decision tree and the data from monitor, choices of interventions are used.

Outcome Measures

Primary Outcome Measures

1. Number of ICU Stays Greater Than 1.5 Days [20 Days]

   the sum of ICU stays greater than the 1.5 Days eligibility for discharge from hospital according to the surgeon, over the course of 20 Days

Secondary Outcome Measures

1. Creatinine Change [Baseline and 72 hours]

   Change in creatinine in the 72 hour post-op period (mg/dL)

Other Outcome Measures

1. Pulmonary Status as Measured by the Number of Participants Who Require Supplemental Oxygen [1 day]

   We looked at the number of patients who required supplemental oxygen within the first 24 hours after surgery.

2. Organ Oxygenation as Measured by Serum Lactate [Baseline and 24 Hours]

   Serum lactate levels, as measured in mmol/L, in patients during the first 24 hours after surgery.

3. Organ Oxygenation as Measured by Arterial Blood Gas Values [Baseline and 1 day]

   Patient's organ oxygenation as measured by base deficit mEq/L, during the first 24 hours after surgery.

4. Fluid Balance Measured by Inputs and Outputs (I/Os) of All Measurable Fluid in Peri-operative Period [Baseline and 12 Hours]

   Fluid balance measured by I/Os of all fluid in the peri-op period during the first 12 hours after the subject's surgery.

5. Patients Requiring Fluid Bolus for Management [1 day]

   Number of patients who received fluid boluses in the first 24 hours post-op

6. Number of Patients Treated for Hypotension With Phenylephrine Drip [1 day]

   The number of patients on a phenylephrine drip within 24 hours post-op.

7. Area Under Curve of MAP Below 65 [1 Day]

   Hypotension as measured by area under the curve of MAP less than 65.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Neurosurgical patients with concerns for decreased intracranial compliance;

• Orthopedic spine patients;

• Patients scheduled to undergo neurosurgical interventions that include any of the following will be eligible: intracranial aneurysm repair; or, major spine surgery.

Exclusion Criteria:

• Patients with permanent cardiac arrhythmias;

• Patients with severe aortic regurgitation;

• Patients with intra-aortic balloon pump (IABP);

• Patients undergoing emergency surgery; and,

• Women who are pregnant and/or nursing will be excluded.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New York University School of Medicine	New York	New York	United States	10016

Sponsors and Collaborators

• NYU Langone Health

Investigators

• Principal Investigator: Marc Bloom, MD, New York University Medical School

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: NYU Langone Health
• ClinicalTrials.gov Identifier: NCT02701582
• Other Study ID Numbers: 13-01043
• First Posted: Mar 8, 2016
• Last Update Posted: Aug 28, 2019
• Last Verified: Aug 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Additional relevant MeSH terms: Scoliosis; Intracranial Aneurysm; Brain Edema; Aneurysm; Phenylephrine; Epinephrine; Oxymetazoline; Synephrine

Study Results

Participant Flow

Recruitment Details	Patients were prescreened and slate was given to PI for approval. Patients were approached in pre-op on day of surgery in a private setting. Study was discussed with them and questions were answered. If interested, they signed consent. Study team began screening patients after receiving IRB approval. The first patient was consented on 3/13/14.

Arm/Group Title	Goal Directed Therapy	Control Group
Arm/Group Description	Anesthesiologists have access to monitor, so they can follow the study algorithm, for the duration of the surgery. Anesthesiologist may choose to discontinue the study algorithm at any time based on his or her best clinical judgment. Clinical judgment can and must always override the study protocol if discrepancy exists. If this occurs, the patient would be considered to fail the protocol, and be considered in a separate group in data analysis. FloTrac Sensor: Care based on algorithm and device.	FloTrac will be connected to the monitor but anesthesiologists will not be able to see the monitor. The data will be collected and stored for analysis. Anesthesiologist will choose from the same drug and fluid options used in the FloTrac (GDT) group (phenylephrine, epinephrine, normal saline, albumin, Voluven), but to be used in accordance with their best clinical judgment without the aid of the FloTrac data. If a discrepancy exists, the attending anesthesiologist may choose to use other therapies not included in the GDT protocol, in accordance with their best clinical judgment. If this happens, the subject would be considered to fail the protocol, and be considered in a separate group in data analysis. FloTrac Algorithm Not Visible: Standard of Care
Period Title: Overall Study
STARTED	35	33
COMPLETED	33	33
NOT COMPLETED	2	0

Baseline Characteristics

Arm/Group Title	Goal DIrected Therapy	Control Group	Total
Arm/Group Description	Anesthesiologist will be able to see the dynamic indicators, and will be given a study algorithm to follow, based on the trending data, for the duration of the surgery. Anesthesiologist may choose to discontinue the study algorithm at any time based on his or her best clinical judgment. Clinical judgment can and must always override the study protocol if discrepancy exists. If this occurs, the patient would be considered to fail the protocol, and be considered in a separate group in data analysis. FloTrac Sensor: Care based on algorithm and device.	FloTrac will be connected to the monitor, the anesthesiologist will not be able to see the monitor although the data will be collected and stored for analysis. Anesthesiologist will be asked to choose from the same drug and fluid options used in the GDT group (phenylephrine, epinephrine, normal saline, albumin, Voluven), but to be used in accordance with their best clinical judgment without the aid of FloTrac data. If a discrepancy exists, the attending anesthesiologist may choose to use other therapies not included in the GDT protocol, in accordance with their best clinical judgment. If this happens, the subject would be considered to fail the protocol, and be considered in a separate group in data analysis. FloTrac Algorithm Not Visible: Standard of Care	Total of all reporting groups
Overall Participants	35	33	68
Age (Count of Participants)
<=18 years	1 2.9%	1 3%	2 2.9%
Between 18 and 65 years	22 62.9%	22 66.7%	44 64.7%
>=65 years	12 34.3%	10 30.3%	22 32.4%
Sex: Female, Male (Count of Participants)
Female	13 37.1%	16 48.5%	29 42.6%
Male	22 62.9%	17 51.5%	39 57.4%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 5.7%	2 6.1%	4 5.9%
Not Hispanic or Latino	31 88.6%	28 84.8%	59 86.8%
Unknown or Not Reported	2 5.7%	3 9.1%	5 7.4%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	2 5.7%	0 0%	2 2.9%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	3 8.6%	4 12.1%	7 10.3%
White	26 74.3%	24 72.7%	50 73.5%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	4 11.4%	5 15.2%	9 13.2%
Region of Enrollment (participants) [Number]
United States	35 100%	33 100%	68 100%

Outcome Measures

1. Primary Outcome

Title	Number of ICU Stays Greater Than 1.5 Days
Description	the sum of ICU stays greater than the 1.5 Days eligibility for discharge from hospital according to the surgeon, over the course of 20 Days
Time Frame	20 Days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Goal Directed Therapy	Control Group
Arm/Group Description	FloTrac monitor visible, care based on algorithm and device.	FloTrac monitor not visible, standard of care
Measure Participants	33	33
Number (95% Confidence Interval) [Number of ICU Stays greater that 1.5 Day]	13	20

2. Secondary Outcome

Title	Creatinine Change
Description	Change in creatinine in the 72 hour post-op period (mg/dL)
Time Frame	Baseline and 72 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Goal Directed Therapy	Control Group
Arm/Group Description	Anesthesiologists have access to monitor, so they can follow the study algorithm, for the duration of the surgery. Anesthesiologist may choose to discontinue the study algorithm at any time based on his or her best clinical judgment. Clinical judgment can and must always override the study protocol if discrepancy exists. If this occurs, the patient would be considered to fail the protocol, and be considered in a separate group in data analysis. FloTrac Sensor: Care based on algorithm and device.	FloTrac will be connected to the monitor but anesthesiologists will not be able to see the monitor. The data will be collected and stored for analysis. Anesthesiologist will choose from the same drug and fluid options used in the FloTrac (GDT) group (phenylephrine, epinephrine, normal saline, albumin, Voluven), but to be used in accordance with their best clinical judgment without the aid of the FloTrac data. If a discrepancy exists, the attending anesthesiologist may choose to use other therapies not included in the GDT protocol, in accordance with their best clinical judgment. If this happens, the subject would be considered to fail the protocol, and be considered in a separate group in data analysis. FloTrac Algorithm Not Visible: Standard of Care
Measure Participants	33	33
Mean (Standard Deviation) [mg/dL]	-0.04 (0.25)	-0.13 (0.16)

3. Other Pre-specified Outcome

Title	Pulmonary Status as Measured by the Number of Participants Who Require Supplemental Oxygen
Description	We looked at the number of patients who required supplemental oxygen within the first 24 hours after surgery.
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Goal Directed Therapy	Control Group
Arm/Group Description	Anesthesiologists have access to monitor, so they can follow the study algorithm, for the duration of the surgery. Anesthesiologist may choose to discontinue the study algorithm at any time based on his or her best clinical judgment. Clinical judgment can and must always override the study protocol if discrepancy exists. If this occurs, the patient would be considered to fail the protocol, and be considered in a separate group in data analysis. FloTrac Sensor: Care based on algorithm and device.	FloTrac will be connected to the monitor but anesthesiologists will not be able to see the monitor. The data will be collected and stored for analysis. Anesthesiologist will choose from the same drug and fluid options used in the FloTrac (GDT) group (phenylephrine, epinephrine, normal saline, albumin, Voluven), but to be used in accordance with their best clinical judgment without the aid of the FloTrac data. If a discrepancy exists, the attending anesthesiologist may choose to use other therapies not included in the GDT protocol, in accordance with their best clinical judgment. If this happens, the subject would be considered to fail the protocol, and be considered in a separate group in data analysis. FloTrac Algorithm Not Visible: Standard of Care
Measure Participants	33	33
Count of Participants [Participants]	17 48.6%	25 75.8%

4. Other Pre-specified Outcome

Title	Organ Oxygenation as Measured by Serum Lactate
Description	Serum lactate levels, as measured in mmol/L, in patients during the first 24 hours after surgery.
Time Frame	Baseline and 24 Hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Goal Directed Therapy	Control Group
Arm/Group Description	Anesthesiologists have access to monitor, so they can follow the study algorithm, for the duration of the surgery. Anesthesiologist may choose to discontinue the study algorithm at any time based on his or her best clinical judgment. Clinical judgment can and must always override the study protocol if discrepancy exists. If this occurs, the patient would be considered to fail the protocol, and be considered in a separate group in data analysis. FloTrac Sensor: Care based on algorithm and device.	FloTrac will be connected to the monitor but anesthesiologists will not be able to see the monitor. The data will be collected and stored for analysis. Anesthesiologist will choose from the same drug and fluid options used in the FloTrac (GDT) group (phenylephrine, epinephrine, normal saline, albumin, Voluven), but to be used in accordance with their best clinical judgment without the aid of the FloTrac data. If a discrepancy exists, the attending anesthesiologist may choose to use other therapies not included in the GDT protocol, in accordance with their best clinical judgment. If this happens, the subject would be considered to fail the protocol, and be considered in a separate group in data analysis. FloTrac Algorithm Not Visible: Standard of Care
Measure Participants	33	33
Mean (Standard Deviation) [mmol/L]	2.0 (1.15)	1.75 (1.04)

5. Other Pre-specified Outcome

Title	Organ Oxygenation as Measured by Arterial Blood Gas Values
Description	Patient's organ oxygenation as measured by base deficit mEq/L, during the first 24 hours after surgery.
Time Frame	Baseline and 1 day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Goal Directed Therapy	Control Group
Arm/Group Description	Anesthesiologists have access to monitor, so they can follow the study algorithm, for the duration of the surgery. Anesthesiologist may choose to discontinue the study algorithm at any time based on his or her best clinical judgment. Clinical judgment can and must always override the study protocol if discrepancy exists. If this occurs, the patient would be considered to fail the protocol, and be considered in a separate group in data analysis. FloTrac Sensor: Care based on algorithm and device.	FloTrac will be connected to the monitor but anesthesiologists will not be able to see the monitor. The data will be collected and stored for analysis. Anesthesiologist will choose from the same drug and fluid options used in the FloTrac (GDT) group (phenylephrine, epinephrine, normal saline, albumin, Voluven), but to be used in accordance with their best clinical judgment without the aid of the FloTrac data. If a discrepancy exists, the attending anesthesiologist may choose to use other therapies not included in the GDT protocol, in accordance with their best clinical judgment. If this happens, the subject would be considered to fail the protocol, and be considered in a separate group in data analysis. FloTrac Algorithm Not Visible: Standard of Care
Measure Participants	33	33
Mean (Standard Deviation) [mEq/L]	3.55 (3.96)	4.75 (4.45)

6. Other Pre-specified Outcome

Title	Fluid Balance Measured by Inputs and Outputs (I/Os) of All Measurable Fluid in Peri-operative Period
Description	Fluid balance measured by I/Os of all fluid in the peri-op period during the first 12 hours after the subject's surgery.
Time Frame	Baseline and 12 Hours

Outcome Measure Data

Analysis Population Description

Data not collected. This outcome measure was not included by PI in reported results

Arm/Group Title	Goal Directed Therapy	Control Group
Arm/Group Description	Anesthesiologists have access to monitor, so they can follow the study algorithm, for the duration of the surgery. Anesthesiologist may choose to discontinue the study algorithm at any time based on his or her best clinical judgment. Clinical judgment can and must always override the study protocol if discrepancy exists. If this occurs, the patient would be considered to fail the protocol, and be considered in a separate group in data analysis. FloTrac Sensor: Care based on algorithm and device.	FloTrac will be connected to the monitor but anesthesiologists will not be able to see the monitor. The data will be collected and stored for analysis. Anesthesiologist will choose from the same drug and fluid options used in the FloTrac (GDT) group (phenylephrine, epinephrine, normal saline, albumin, Voluven), but to be used in accordance with their best clinical judgment without the aid of the FloTrac data. If a discrepancy exists, the attending anesthesiologist may choose to use other therapies not included in the GDT protocol, in accordance with their best clinical judgment. If this happens, the subject would be considered to fail the protocol, and be considered in a separate group in data analysis. FloTrac Algorithm Not Visible: Standard of Care
Measure Participants	33	33
Mean (Standard Deviation) [ml/kg]	NA (NA)	NA (NA)

7. Other Pre-specified Outcome

Title	Patients Requiring Fluid Bolus for Management
Description	Number of patients who received fluid boluses in the first 24 hours post-op
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Goal Directed Therapy	Control Group
Arm/Group Description	Anesthesiologists have access to monitor, so they can follow the study algorithm, for the duration of the surgery. Anesthesiologist may choose to discontinue the study algorithm at any time based on his or her best clinical judgment. Clinical judgment can and must always override the study protocol if discrepancy exists. If this occurs, the patient would be considered to fail the protocol, and be considered in a separate group in data analysis. FloTrac Sensor: Care based on algorithm and device.	FloTrac will be connected to the monitor but anesthesiologists will not be able to see the monitor. The data will be collected and stored for analysis. Anesthesiologist will choose from the same drug and fluid options used in the FloTrac (GDT) group (phenylephrine, epinephrine, normal saline, albumin, Voluven), but to be used in accordance with their best clinical judgment without the aid of the FloTrac data. If a discrepancy exists, the attending anesthesiologist may choose to use other therapies not included in the GDT protocol, in accordance with their best clinical judgment. If this happens, the subject would be considered to fail the protocol, and be considered in a separate group in data analysis. FloTrac Algorithm Not Visible: Standard of Care
Measure Participants	33	33
Count of Participants [Participants]	7 20%	6 18.2%

8. Other Pre-specified Outcome

Title	Number of Patients Treated for Hypotension With Phenylephrine Drip
Description	The number of patients on a phenylephrine drip within 24 hours post-op.
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Goal Directed Therapy	Control Group
Arm/Group Description	Anesthesiologists have access to monitor, so they can follow the study algorithm, for the duration of the surgery. Anesthesiologist may choose to discontinue the study algorithm at any time based on his or her best clinical judgment. Clinical judgment can and must always override the study protocol if discrepancy exists. If this occurs, the patient would be considered to fail the protocol, and be considered in a separate group in data analysis. FloTrac Sensor: Care based on algorithm and device.	FloTrac will be connected to the monitor but anesthesiologists will not be able to see the monitor. The data will be collected and stored for analysis. Anesthesiologist will choose from the same drug and fluid options used in the FloTrac (GDT) group (phenylephrine, epinephrine, normal saline, albumin, Voluven), but to be used in accordance with their best clinical judgment without the aid of the FloTrac data. If a discrepancy exists, the attending anesthesiologist may choose to use other therapies not included in the GDT protocol, in accordance with their best clinical judgment. If this happens, the subject would be considered to fail the protocol, and be considered in a separate group in data analysis. FloTrac Algorithm Not Visible: Standard of Care
Measure Participants	33	33
Count of Participants [Participants]	0 0%	4 12.1%

9. Other Pre-specified Outcome

Title	Area Under Curve of MAP Below 65
Description	Hypotension as measured by area under the curve of MAP less than 65.
Time Frame	1 Day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Goal Directed Therapy	Control Group
Arm/Group Description	Anesthesiologists have access to monitor, so they can follow the study algorithm, for the duration of the surgery. Anesthesiologist may choose to discontinue the study algorithm at any time based on his or her best clinical judgment. Clinical judgment can and must always override the study protocol if discrepancy exists. If this occurs, the patient would be considered to fail the protocol, and be considered in a separate group in data analysis. FloTrac Sensor: Care based on algorithm and device.	FloTrac will be connected to the monitor but anesthesiologists will not be able to see the monitor. The data will be collected and stored for analysis. Anesthesiologist will choose from the same drug and fluid options used in the FloTrac (GDT) group (phenylephrine, epinephrine, normal saline, albumin, Voluven), but to be used in accordance with their best clinical judgment without the aid of the FloTrac data. If a discrepancy exists, the attending anesthesiologist may choose to use other therapies not included in the GDT protocol, in accordance with their best clinical judgment. If this happens, the subject would be considered to fail the protocol, and be considered in a separate group in data analysis. FloTrac Algorithm Not Visible: Standard of Care
Measure Participants	33	33
Mean (Standard Deviation) [mmHG x minutes]	-65.06 (63.89)	-61.88 (64.23)

Adverse Events

Arm/Group Title	FloTrac Sensor		Control Group
Arm/Group Description	FloTrac monitor visible, care based on algorithm and device.		FloTrac monitor not visible, standard of care
All Cause Mortality
	FloTrac Sensor		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/35 (0%)		0/33 (0%)
Serious Adverse Events
	FloTrac Sensor		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/35 (0%)		0/33 (0%)
Other (Not Including Serious) Adverse Events
	FloTrac Sensor		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/35 (0%)		0/33 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT 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.