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Furosemide vs Placebo for Brain Relaxation

NCT01054404 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2013-08-02

Study results available
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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.

Conditions

Interventions

DRUG

Furosemide

Furosemide 0.3 mg/kg

DRUG

Placebo

Placebo (up to 5mL)

Sponsors & Collaborators

Principal Investigators

  • John F Bebawy, MD · Northwestern University

  • Dhanesh K Gupta, MD · Northwestern University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2012-03-31
Completion
2012-03-31

Countries

  • United States

Study Locations

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Drugs
Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01054404 on ClinicalTrials.gov