Furosemide vs Placebo for Brain Relaxation

June 27, 2013 updated by: John Bebawy, Northwestern University

The Effect of Furosemide Versus Placebo on Brain Relaxation and Incidence of Significant Intravascular Volume Depletion in Human Subjects Receiving Mannitol

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Actual)

23

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Furosemide
Furosemide 0.3 mg/kg
Drug: Furosemide
Furosemide 0.3 mg/kg
Other Names:
  • Lasix
Placebo Comparator: Placebo
Up to 5 mL saline
Drug: Placebo
Placebo (up to 5mL)
Other Names:
  • Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
just prior to dural opening for each subject

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Investigators

  • Principal Investigator: John F Bebawy, MD, Northwestern University
  • Study Director: Dhanesh K Gupta, MD, Northwestern University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

January 20, 2010

First Submitted That Met QC Criteria

January 20, 2010

First Posted (Estimate)

January 22, 2010

Study Record Updates

Last Update Posted (Estimate)

August 2, 2013

Last Update Submitted That Met QC Criteria

June 27, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU00016126

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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