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

Primary Purpose

Intracranial Aneurysm, Brain Edema, Scoliosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Phenylephrine
Epinephrine
Albumin
Voluven
Normal Saline
Packed Red Blood Cells
FloTrac Monitor
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intracranial Aneurysm

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • New York University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Goal Directed Therapy

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Number of ICU Stays Greater Than 1.5 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

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

Full Information

First Posted
February 22, 2016
Last Updated
August 16, 2019
Sponsor
NYU Langone Health
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1. Study Identification

Unique Protocol Identification Number
NCT02701582
Brief Title
Goal-Directed Intraoperative Fluid Management Using FloTrac© Monitoring in High-Risk Neurosurgical Patients
Official Title
Goal-Directed Intraoperative Fluid Management Using FloTrac© Monitoring in High-Risk Neurosurgical Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Aneurysm, Brain Edema, Scoliosis, Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Goal Directed Therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Phenylephrine
Other Intervention Name(s)
Sudafed, Neo-Synephrine, SudoGest
Intervention Description
if Mean arterial pressure (MAP) is < = 65, Stroke volume variation (SVV) < 13 and Cardiac Index is >=2.2 Phenylephrine is administered
Intervention Type
Drug
Intervention Name(s)
Epinephrine
Other Intervention Name(s)
EpiPen, Adrenaclick, Medihaler-Epi
Intervention Description
if Mean arterial pressure (MAP) is < = 65, Stroke volume variation (SVV) < 13 and Cardiac Index is < 2.2 Epinephrine is administered
Intervention Type
Other
Intervention Name(s)
Albumin
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Voluven
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Normal Saline
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Packed Red Blood Cells
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
FloTrac Monitor
Intervention Description
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.
Primary Outcome Measure Information:
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
Secondary Outcome Measure Information:
Title
Creatinine Change
Description
Change in creatinine in the 72 hour post-op period (mg/dL)
Time Frame
Baseline and 72 hours
Other Pre-specified Outcome Measures:
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
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
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
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
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
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
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Bloom, MD
Organizational Affiliation
New York University Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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