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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 ;


Study Design


Related Conditions & MeSH terms


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

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