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

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.

Study Overview

• Status: Completed
• Conditions: Scoliosis; Surgery; Intracranial Aneurysm; Brain Edema
• Intervention / Treatment: Drug: Phenylephrine; Drug: Epinephrine; Other: Albumin; Other: Voluven; Other: Normal Saline; Other: Packed Red Blood Cells; Device: FloTrac Monitor

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

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Goal Directed Therapy; 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; if Mean arterial pressure (MAP) is < = 65, Stroke volume variation (SVV) < 13 and Cardiac Index is >=2.2 Phenylephrine is administered; Other Names: Sudafed; Neo-Synephrine; SudoGest; Drug: Epinephrine; if Mean arterial pressure (MAP) is < = 65, Stroke volume variation (SVV) < 13 and Cardiac Index is < 2.2 Epinephrine is administered; Other Names: EpiPen; Adrenaclick; Medihaler-Epi; 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.
Active Comparator: Control Group; 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; if Mean arterial pressure (MAP) is < = 65, Stroke volume variation (SVV) < 13 and Cardiac Index is >=2.2 Phenylephrine is administered; Other Names: Sudafed; Neo-Synephrine; SudoGest; Drug: Epinephrine; if Mean arterial pressure (MAP) is < = 65, Stroke volume variation (SVV) < 13 and Cardiac Index is < 2.2 Epinephrine is administered; Other Names: EpiPen; Adrenaclick; Medihaler-Epi; 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.

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pulmonary Status as Measured by the Number of Participants Who Require Supplemental Oxygen	We looked at the number of patients who required supplemental oxygen within the first 24 hours after surgery.	1 day
Organ Oxygenation as Measured by Serum Lactate	Serum lactate levels, as measured in mmol/L, in patients during the first 24 hours after surgery.	Baseline and 24 Hours
Organ Oxygenation as Measured by Arterial Blood Gas Values	Patient's organ oxygenation as measured by base deficit mEq/L, during the first 24 hours after surgery.	Baseline and 1 day
Fluid Balance Measured by Inputs and Outputs (I/Os) of All Measurable Fluid in Peri-operative Period	Fluid balance measured by I/Os of all fluid in the peri-op period during the first 12 hours after the subject's surgery.	Baseline and 12 Hours
Patients Requiring Fluid Bolus for Management	Number of patients who received fluid boluses in the first 24 hours post-op	1 day
Number of Patients Treated for Hypotension With Phenylephrine Drip	The number of patients on a phenylephrine drip within 24 hours post-op.	1 day
Area Under Curve of MAP Below 65	Hypotension as measured by area under the curve of MAP less than 65.	1 Day

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Marc Bloom, MD, New York University Medical School

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: February 22, 2016
• First Submitted That Met QC Criteria: March 2, 2016
• First Posted (Estimate): March 8, 2016

Study Record Updates

• Last Update Posted (Actual): August 28, 2019
• Last Update Submitted That Met QC Criteria: August 16, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Intracranial Arterial Diseases; Scoliosis; Aneurysm; Intracranial Aneurysm; Brain Edema; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Protective Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Cardiotonic Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Nasal Decongestants; Adrenergic alpha-1 Receptor Agonists; Epinephrine; Phenylephrine; Oxymetazoline; Synephrine
• Other Study ID Numbers: 13-01043

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided