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

Study Overview
=================
Brief 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

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

Conditions
-----------------
Intracranial Aneurysm, Brain Edema, Scoliosis, Surgery

Intervention / Treatment
-----------------
* Drug: Phenylephrine
* Drug: Epinephrine
* Other: Albumin
* Other: Voluven
* Other: Normal Saline
* Other: Packed Red Blood Cells
* Device: FloTrac Monitor


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 15 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Goal Directed Therapy<br>Flotrack monitor is connected and based on what anesthesiologist sees and following study algorithm, anesthesiologist chooses: Phenylephrine, Epinephrine , volume resuscitation (fluids, including normal saline, albumin, voluven and packed red blood cells) and no intervention. | Drug: Phenylephrine<br>* if Mean arterial pressure (MAP) is < = 65, Stroke volume variation (SVV) < 13 and Cardiac Index is >=2.2 Phenylephrine is administered<br>* Other names: SudoGest;Drug: Epinephrine<br>* if Mean arterial pressure (MAP) is < = 65, Stroke volume variation (SVV) < 13 and Cardiac Index is < 2.2 Epinephrine is administered<br>* Other names: Medihaler-Epi;Other: Albumin<br>* 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.<br>Other: Voluven<br>* 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.<br>Other: Normal Saline<br>* 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.<br>Other: Packed Red Blood Cells<br>* 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.<br>Device: FloTrac Monitor<br>* 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.<br>|
| Active Comparator: Control Group<br>FloTrac monitor is connected, but he anesthesiologist will not be able to see the monitor although the data will be collected and stored for analysis. Anesthesiologist will be given a study algorithm to follow for the duration of the surgery, and based on it will choose: Phenylephrine, Epinephrine , volume resuscitation (fluids, including normal saline, albumin, voluven and packed red blood cells) and no intervention. | Drug: Phenylephrine<br>* if Mean arterial pressure (MAP) is < = 65, Stroke volume variation (SVV) < 13 and Cardiac Index is >=2.2 Phenylephrine is administered<br>* Other names: SudoGest;Drug: Epinephrine<br>* if Mean arterial pressure (MAP) is < = 65, Stroke volume variation (SVV) < 13 and Cardiac Index is < 2.2 Epinephrine is administered<br>* Other names: Medihaler-Epi;Other: Albumin<br>* 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.<br>Other: Voluven<br>* 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.<br>Other: Normal Saline<br>* 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.<br>Other: Packed Red Blood Cells<br>* 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.<br>Device: FloTrac Monitor<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of ICU Stays Greater Than 1.5 Days | the sum of ICU stays greater than the 1.5 Days eligibility for discharge from hospital according to the surgeon, over the course of 20 Days | 20 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Creatinine Change | Change in creatinine in the 72 hour post-op period (mg/dL) | Baseline and 72 hours |