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



Status:Completed
Conditions:Cardiology, Neurology, Orthopedic
Therapuetic Areas:Cardiology / Vascular Diseases, Neurology, Orthopedics / Podiatry
Healthy:No
Age Range:15 - Any
Updated:11/29/2017
Start Date:March 2014
End Date:September 2016

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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.

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

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.
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