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Furosemide vs Placebo for Brain Relaxation

Primary Purpose

Brain Swelling, Brain Edema, Dehydration

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Furosemide
Placebo
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Swelling focused on measuring Brain Swelling, Brain Edema, Dehydration

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Northwestern University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Furosemide

Placebo

Arm Description

Furosemide 0.3 mg/kg

Up to 5 mL saline

Outcomes

Primary Outcome Measures

Acceptable vs. Unacceptable Brain Relaxation at Dural Opening
Rating of brain relaxation will be on a 4-point scale: 0 = brain very relaxed under dura, acceptable = brain adequately relaxed under dura, acceptable = brain slightly tense under dura, acceptable = brain very tense under bulging dura, unacceptable

Secondary Outcome Measures

Full Information

First Posted
January 20, 2010
Last Updated
June 27, 2013
Sponsor
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT01054404
Brief Title
Furosemide vs Placebo for Brain Relaxation
Official Title
The Effect of Furosemide Versus Placebo on Brain Relaxation and Incidence of Significant Intravascular Volume Depletion in Human Subjects Receiving Mannitol
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Terminated
Why Stopped
Concern for volume depletion and electrolyte abnormalities in furosemide arm.
Study Start Date
February 2010 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Rating of brain relaxation will be on a 4-point scale: 0 = brain very relaxed under dura, acceptable = brain adequately relaxed under dura, acceptable = brain slightly tense under dura, acceptable = brain very tense under bulging dura, unacceptable

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Swelling, Brain Edema, Dehydration
Keywords
Brain Swelling, Brain Edema, Dehydration

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Furosemide
Arm Type
Active Comparator
Arm Description
Furosemide 0.3 mg/kg
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Up to 5 mL saline
Intervention Type
Drug
Intervention Name(s)
Furosemide
Other Intervention Name(s)
Lasix
Intervention Description
Furosemide 0.3 mg/kg
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Saline
Intervention Description
Placebo (up to 5mL)
Primary Outcome Measure Information:
Title
Acceptable vs. Unacceptable Brain Relaxation at Dural Opening
Description
Rating of brain relaxation will be on a 4-point scale: 0 = brain very relaxed under dura, acceptable = brain adequately relaxed under dura, acceptable = brain slightly tense under dura, acceptable = brain very tense under bulging dura, unacceptable
Time Frame
just prior to dural opening for each subject

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John F Bebawy, MD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dhanesh K Gupta, MD
Organizational Affiliation
Northwestern University
Official's Role
Study Director
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
11818776
Citation
Thenuwara K, Todd MM, Brian JE Jr. Effect of mannitol and furosemide on plasma osmolality and brain water. Anesthesiology. 2002 Feb;96(2):416-21. doi: 10.1097/00000542-200202000-00029.
Results Reference
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PubMed Identifier
17122580
Citation
Todd MM, Cutkomp J, Brian JE. Influence of mannitol and furosemide, alone and in combination, on brain water content after fluid percussion injury. Anesthesiology. 2006 Dec;105(6):1176-81. doi: 10.1097/00000542-200612000-00017.
Results Reference
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PubMed Identifier
6412595
Citation
Rudehill A, Lagerkranser M, Lindquist C, Gordon E. Effects of mannitol on blood volume and central hemodynamics in patients undergoing cerebral aneurysm surgery. Anesth Analg. 1983 Oct;62(10):875-80.
Results Reference
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PubMed Identifier
8512094
Citation
Todd MM, Warner DS, Sokoll MD, Maktabi MA, Hindman BJ, Scamman FL, Kirschner J. A prospective, comparative trial of three anesthetics for elective supratentorial craniotomy. Propofol/fentanyl, isoflurane/nitrous oxide, and fentanyl/nitrous oxide. Anesthesiology. 1993 Jun;78(6):1005-20. doi: 10.1097/00000542-199306000-00002.
Results Reference
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PubMed Identifier
18073543
Citation
Rozet I, Tontisirin N, Muangman S, Vavilala MS, Souter MJ, Lee LA, Kincaid MS, Britz GW, Lam AM. Effect of equiosmolar solutions of mannitol versus hypertonic saline on intraoperative brain relaxation and electrolyte balance. Anesthesiology. 2007 Nov;107(5):697-704. doi: 10.1097/01.anes.0000286980.92759.94.
Results Reference
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Furosemide vs Placebo for Brain Relaxation

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