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

Status Completed

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.

Clinical Trial 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 ;

Related Conditions & MeSH terms

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

• NCT number: NCT02701582
• Study type: Interventional
• Source: NYU Langone Health
• Status: Completed
• Phase: N/A
• Start date: March 2014
• Completion date: September 2016