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

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.

Conditions

• Intracranial Aneurysm
• Brain Edema
• Scoliosis
• Surgery

Interventions

DRUG

Phenylephrine

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

DRUG

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.

OTHER

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.

OTHER

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.

OTHER

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.

Sponsors & Collaborators

• NYU Langone Health

  lead OTHER

Principal Investigators

• Marc Bloom, MD · New York University Medical School

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

15 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-03-31

Primary Completion

2016-01-31

Completion

2016-09-30

Countries

• United States

Study Locations