NCT02701582

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

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

Conditions

• Intracranial Aneurysm
• Brain Edema
• Scoliosis
• Surgery

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2014-03-01
• Primary completion: 2016-01-01
• Completion: 2016-09-01
• First posted: 2016-03-08
• Last updated: 2019-08-28
• Results posted: 2019-08-19

Locations

1 site across 1 country: United States