Clinical trial NCT02701582: 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
Overall status: COMPLETED
Phase: NA
Conditions: Intracranial Aneurysm
Brain Edema
Scoliosis
Surgery
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2016-03-08
Enrollment: 66
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Number of ICU Stays Greater Than 1.5 Days
timeFrame: 20 Days
Secondary outcomes:
measure: Creatinine Change
timeFrame: Baseline and 72 hours
Other outcomes:
measure: Pulmonary Status as Measured by the Number of Participants Who Require Supplemental Oxygen
timeFrame: 1 day
measure: Organ Oxygenation as Measured by Serum Lactate
timeFrame: Baseline and 24 Hours
measure: Organ Oxygenation as Measured by Arterial Blood Gas Values
timeFrame: Baseline and 1 day
measure: Fluid Balance Measured by Inputs and Outputs (I/Os) of All Measurable Fluid in Peri-operative Period
timeFrame: Baseline and 12 Hours
measure: Patients Requiring Fluid Bolus for Management
timeFrame: 1 day
measure: Number of Patients Treated for Hypotension With Phenylephrine Drip
timeFrame: 1 day
measure: Area Under Curve of MAP Below 65
timeFrame: 1 Day
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: New York University Medical School
name: Marc Bloom, MD
role: PRINCIPAL_INVESTIGATOR
References: