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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02701582
• Other study ID #: 13-01043
• Status: Completed
• Phase: N/A
• Start date: March 2014
• Est. completion date: September 2016

Study information

• Verified date: August 2019
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: September 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysm
• Brain Edema
• Intracranial Aneurysm
• Scoliosis
• Surgery

Intervention

Drug:
• Phenylephrine
if Mean arterial pressure (MAP) is < = 65, Stroke volume variation (SVV) < 13 and Cardiac Index is >=2.2 Phenylephrine is administered
• Epinephrine
if Mean arterial pressure (MAP) is < = 65, Stroke volume variation (SVV) < 13 and Cardiac Index is < 2.2 Epinephrine is administered

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pulmonary Status as Measured by the Number of Participants Who Require Supplemental Oxygen	We looked at the number of patients who required supplemental oxygen within the first 24 hours after surgery.	1 day
Other	Organ Oxygenation as Measured by Serum Lactate	Serum lactate levels, as measured in mmol/L, in patients during the first 24 hours after surgery.	Baseline and 24 Hours
Other	Organ Oxygenation as Measured by Arterial Blood Gas Values	Patient's organ oxygenation as measured by base deficit mEq/L, during the first 24 hours after surgery.	Baseline and 1 day
Other	Fluid Balance Measured by Inputs and Outputs (I/Os) of All Measurable Fluid in Peri-operative Period	Fluid balance measured by I/Os of all fluid in the peri-op period during the first 12 hours after the subject's surgery.	Baseline and 12 Hours
Other	Patients Requiring Fluid Bolus for Management	Number of patients who received fluid boluses in the first 24 hours post-op	1 day
Other	Number of Patients Treated for Hypotension With Phenylephrine Drip	The number of patients on a phenylephrine drip within 24 hours post-op.	1 day
Other	Area Under Curve of MAP Below 65	Hypotension as measured by area under the curve of MAP less than 65.	1 Day
Primary	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	Creatinine Change	Change in creatinine in the 72 hour post-op period (mg/dL)	Baseline and 72 hours