Furosemide vs Placebo for Brain Relaxation

This study has been terminated.
(Concern for volume depletion and electrolyte abnormalities in furosemide arm.)
Sponsor:
Information provided by (Responsible Party):
John Bebawy, Northwestern University
ClinicalTrials.gov Identifier:
NCT01054404
First received: January 20, 2010
Last updated: June 27, 2013
Last verified: June 2013
  Purpose

Increased brain bulk may be problematic during brain surgery for tumors because it may limit surgical exposure and access to the surgical site. Mannitol, an osmotic diuretic, is commonly given to alleviate brain bulk, and sometimes furosemide in a small dose is added if mannitol alone is insufficient. It is unclear if adding this furosemide truly helps to diminish brain bulk, and it is possible that furosemide may cause too much diuresis, leading to dehydration and its side effects (e.g., low blood pressure). Our purpose is to investigate what the effects of furosemide are in the setting of brain surgery for tumors, specifically with regards to decreasing brain bulk and/or causing dehydration.

Study Hypothesis: The addition of furosemide to mannitol will result in improved brain relaxation in human subjects undergoing craniotomy for brain tumor resection than that seen with mannitol alone. However, the combination of mannitol and furosemide will also lead to more significant intravascular volume depletion than that seen with mannitol alone.


Condition Intervention
Brain Swelling
Brain Edema
Dehydration
Drug: Furosemide
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Furosemide Versus Placebo on Brain Relaxation and Incidence of Significant Intravascular Volume Depletion in Human Subjects Receiving Mannitol

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Acceptable vs. Unacceptable Brain Relaxation at Dural Opening [ Time Frame: just prior to dural opening for each subject ] [ Designated as safety issue: No ]

    Rating of brain relaxation will be on a 4-point scale:

    0 = brain very relaxed under dura, acceptable

    1. = brain adequately relaxed under dura, acceptable
    2. = brain slightly tense under dura, acceptable
    3. = brain very tense under bulging dura, unacceptable


Enrollment: 23
Study Start Date: February 2010
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Furosemide
Furosemide 0.3 mg/kg
Drug: Furosemide
Furosemide 0.3 mg/kg
Other Name: Lasix
Placebo Comparator: Placebo
Up to 5 mL saline
Drug: Placebo
Placebo (up to 5mL)
Other Name: Saline

Detailed Description:

Rating of brain relaxation will be on a 4-point scale:

0 = brain very relaxed under dura, acceptable

  1. = brain adequately relaxed under dura, acceptable
  2. = brain slightly tense under dura, acceptable
  3. = brain very tense under bulging dura, unacceptable
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Inclusion criteria include:

    • ASA PS I-III
    • Age 18 or older
    • Presenting for elective resection of primary or metastatic supratentorial brain tumor(s)

Exclusion Criteria:

  • • ASA PS IV or V

    • Age less than 18
    • Emergency surgery due to severely elevated ICP/impending brainstem herniation
    • Concurrent use of diuretics for any indication
    • Infratentorial/posterior fossa/cerebellar tumor resection
    • Moderate/severe cardiac disease with limitation in contractility as measured by preoperative echocardiogram (EF < 30%)
    • Severe pulmonary hypertension as measured and/or observed by preoperative studies
    • Preoperative use of steroids (within 6 months, including those on standing doses)
    • Pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01054404

Locations
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: John F Bebawy, MD Northwestern University
Study Director: Dhanesh K Gupta, MD Northwestern University
  More Information

Publications:
Responsible Party: John Bebawy, Assistant Professor of Anesthesiology & Neurological Surgery, Northwestern University
ClinicalTrials.gov Identifier: NCT01054404     History of Changes
Other Study ID Numbers: STU00016126
Study First Received: January 20, 2010
Results First Received: May 8, 2013
Last Updated: June 27, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
Brain Swelling
Brain Edema
Dehydration

Additional relevant MeSH terms:
Brain Edema
Dehydration
Edema
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Water-Electrolyte Imbalance
Metabolic Diseases
Pathologic Processes
Signs and Symptoms
Furosemide
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014