Goal-Directed Intraoperative Fluid Management Using FloTrac© Monitoring in High-Risk Neurosurgical Patients
1 other identifier
interventional
66
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2014
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedFirst Submitted
Initial submission to the registry
February 22, 2016
CompletedFirst Posted
Study publicly available on registry
March 8, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedResults Posted
Study results publicly available
August 19, 2019
CompletedAugust 28, 2019
August 1, 2019
1.8 years
February 22, 2016
August 9, 2017
August 16, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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
20 Days
Secondary Outcomes (1)
Creatinine Change
Baseline and 72 hours
Other Outcomes (7)
Pulmonary Status as Measured by the Number of Participants Who Require Supplemental Oxygen
1 day
Organ Oxygenation as Measured by Serum Lactate
Baseline and 24 Hours
Organ Oxygenation as Measured by Arterial Blood Gas Values
Baseline and 1 day
- +4 more other outcomes
Study Arms (2)
Goal Directed Therapy
EXPERIMENTALFlotrack 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.
Control Group
ACTIVE COMPARATORFloTrac 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.
Interventions
if Mean arterial pressure (MAP) is \< = 65, Stroke volume variation (SVV) \< 13 and Cardiac Index is \>=2.2 Phenylephrine is administered
if Mean arterial pressure (MAP) is \< = 65, Stroke volume variation (SVV) \< 13 and Cardiac Index is \< 2.2 Epinephrine is administered
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.
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.
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
New York University School of Medicine
New York, New York, 10016, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Marc Bloom, MD, PHD
- Organization
- NYU School of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Marc Bloom, MD
New York University Medical School
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 22, 2016
First Posted
March 8, 2016
Study Start
March 1, 2014
Primary Completion
January 1, 2016
Study Completion
September 1, 2016
Last Updated
August 28, 2019
Results First Posted
August 19, 2019
Record last verified: 2019-08