Trial Outcomes & Findings for Goal-Directed Intraoperative Fluid Management Using FloTrac© Monitoring in High-Risk Neurosurgical Patients (NCT NCT02701582)

NCT ID: NCT02701582

Last Updated: 2019-08-28

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 66 participants
• Primary outcome timeframe: 20 Days
• Results posted on: 2019-08-28

Participant Flow

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.

Participant milestones

Measure	Goal Directed Therapy 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.	Control Group 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
Overall Study STARTED	35	33
Overall Study COMPLETED	33	33
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Goal DIrected Therapy n=35 Participants 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.	Control Group n=33 Participants 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 n=68 Participants Total of all reporting groups
Age, Categorical <=18 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	22 Participants n=5 Participants	22 Participants n=7 Participants	44 Participants n=5 Participants
Age, Categorical >=65 years	12 Participants n=5 Participants	10 Participants n=7 Participants	22 Participants n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	16 Participants n=7 Participants	29 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	17 Participants n=7 Participants	39 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	31 Participants n=5 Participants	28 Participants n=7 Participants	59 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) White	26 Participants n=5 Participants	24 Participants n=7 Participants	50 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Region of Enrollment United States	35 participants n=5 Participants	33 participants n=7 Participants	68 participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Goal Directed Therapy n=33 Participants FloTrac monitor visible, care based on algorithm and device.	Control Group n=33 Participants FloTrac monitor not visible, standard of care
Number of ICU Stays Greater Than 1.5 Days	13 Number of ICU Stays greater that 1.5 Day Interval 7.0 to 19.0	20 Number of ICU Stays greater that 1.5 Day Interval 14.0 to 26.0

SECONDARY outcome

Timeframe: Baseline and 72 hours

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

Outcome measures

Measure	Goal Directed Therapy n=33 Participants FloTrac monitor visible, care based on algorithm and device.	Control Group n=33 Participants FloTrac monitor not visible, standard of care
Creatinine Change	-0.04 mg/dL Standard Deviation 0.25	-0.13 mg/dL Standard Deviation 0.16

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 day

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

Outcome measures

Measure	Goal Directed Therapy n=33 Participants FloTrac monitor visible, care based on algorithm and device.	Control Group n=33 Participants FloTrac monitor not visible, standard of care
Pulmonary Status as Measured by the Number of Participants Who Require Supplemental Oxygen	17 Participants	25 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 24 Hours

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

Outcome measures

Measure	Goal Directed Therapy n=33 Participants FloTrac monitor visible, care based on algorithm and device.	Control Group n=33 Participants FloTrac monitor not visible, standard of care
Organ Oxygenation as Measured by Serum Lactate	2.0 mmol/L Standard Deviation 1.15	1.75 mmol/L Standard Deviation 1.04

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 1 day

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

Outcome measures

Measure	Goal Directed Therapy n=33 Participants FloTrac monitor visible, care based on algorithm and device.	Control Group n=33 Participants FloTrac monitor not visible, standard of care
Organ Oxygenation as Measured by Arterial Blood Gas Values	3.55 mEq/L Standard Deviation 3.96	4.75 mEq/L Standard Deviation 4.45

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 12 Hours

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

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

Outcome measures

Measure	Goal Directed Therapy n=33 Participants FloTrac monitor visible, care based on algorithm and device.	Control Group n=33 Participants FloTrac monitor not visible, standard of care
Fluid Balance Measured by Inputs and Outputs (I/Os) of All Measurable Fluid in Peri-operative Period	NA ml/kg Standard Deviation NA This outcome measure was not included by PI in reported results. This outcome measure was not analyzed and is not being provided by PI.	NA ml/kg Standard Deviation NA This outcome measure was not included by PI in reported results. This outcome measure was not analyzed and is not being provided by PI.

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 day

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

Outcome measures

Measure	Goal Directed Therapy n=33 Participants FloTrac monitor visible, care based on algorithm and device.	Control Group n=33 Participants FloTrac monitor not visible, standard of care
Patients Requiring Fluid Bolus for Management	7 Participants	6 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 day

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

Outcome measures

Measure	Goal Directed Therapy n=33 Participants FloTrac monitor visible, care based on algorithm and device.	Control Group n=33 Participants FloTrac monitor not visible, standard of care
Number of Patients Treated for Hypotension With Phenylephrine Drip	0 Participants	4 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 Day

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

Outcome measures

Measure	Goal Directed Therapy n=33 Participants FloTrac monitor visible, care based on algorithm and device.	Control Group n=33 Participants FloTrac monitor not visible, standard of care
Area Under Curve of MAP Below 65	-65.06 mmHG x minutes Standard Deviation 63.89	-61.88 mmHG x minutes Standard Deviation 64.23

Adverse Events

FloTrac Sensor

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Marc Bloom, MD, PHD

NYU School of Medicine

Phone: 305 689-2388

Email: mbloom@miami.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place