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Completed

NCT Number: NCT02701582

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.

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Key information

Conditions

Intracranial Aneurysm Aneurysm Bone Diseases Brain Diseases Brain Edema Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Intracranial Arterial Diseases Musculoskeletal Diseases Nervous System Diseases Scoliosis Spinal Curvatures Spinal Diseases Surgery Vascular Diseases

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York University School of Medicine

New York, 10016, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Phenylephrine

Drug

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

Epinephrine

Drug

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

Albumin

Other

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.

Voluven

Other

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.

Normal Saline

Other

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.

Packed red blood cells

Other

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.

FloTrac Monitor

Device

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.

Primary outcomes

  1. Number of ICU Stays Greater Than 1.5 Days

    Time frame: 20 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

Secondary outcomes

  1. Creatinine Change

    Time frame: Baseline and 72 hours

    Change in creatinine in the 72 hour post-op period (mg/dL)

Other outcomes

  1. Pulmonary Status as Measured by the Number of Participants Who Require Supplemental Oxygen

    Time frame: 1 day

    We looked at the number of patients who required supplemental oxygen within the first 24 hours after surgery.

  2. Organ Oxygenation as Measured by Serum Lactate

    Time frame: Baseline and 24 Hours

    Serum lactate levels, as measured in mmol/L, in patients during the first 24 hours after surgery.

  3. Organ Oxygenation as Measured by Arterial Blood Gas Values

    Time frame: Baseline and 1 day

    Patient's organ oxygenation as measured by base deficit mEq/L, during the first 24 hours after surgery.

  4. Fluid Balance Measured by Inputs and Outputs (I/Os) of All Measurable Fluid in Peri-operative Period

    Time frame: Baseline and 12 Hours

    Fluid balance measured by I/Os of all fluid in the peri-op period during the first 12 hours after the subject's surgery.

  5. Patients Requiring Fluid Bolus for Management

    Time frame: 1 day

    Number of patients who received fluid boluses in the first 24 hours post-op

  6. Number of Patients Treated for Hypotension With Phenylephrine Drip

    Time frame: 1 day

    The number of patients on a phenylephrine drip within 24 hours post-op.

  7. Area Under Curve of MAP Below 65

    Time frame: 1 Day

    Hypotension as measured by area under the curve of MAP less than 65.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Mar 8, 2016
Registry last updated
Aug 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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