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Furosemide vs Placebo for Brain Relaxation

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ClinicalTrials.gov Identifier: NCT01054404
Recruitment Status : Terminated (Concern for volume depletion and electrolyte abnormalities in furosemide arm.)
First Posted : January 22, 2010
Results First Posted : August 2, 2013
Last Update Posted : August 2, 2013
Sponsor:
Information provided by (Responsible Party):
John Bebawy, Northwestern University

Brief Summary:

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 or disease Intervention/treatment Phase
Brain Swelling Brain Edema Dehydration Drug: Furosemide Drug: Placebo Not Applicable

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : February 2010
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dehydration
Drug Information available for: Furosemide
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Acceptable vs. Unacceptable Brain Relaxation at Dural Opening [ Time Frame: just prior to dural opening for each subject ]

    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



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: January 22, 2010    Key Record Dates
Results First Posted: August 2, 2013
Last Update Posted: August 2, 2013
Last Verified: June 2013

Keywords provided by John Bebawy, Northwestern University:
Brain Swelling
Brain Edema
Dehydration

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