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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Brain Swelling
Brain Edema
Dehydration
Interventions Drug: Furosemide
Drug: Placebo
Enrollment 23
Recruitment Details  
Pre-assignment Details 23 patients enrolled sequentially, no dropouts
Arm/Group Title Furosemide Placebo
Hide Arm/Group Description Furosemide : Furosemide 0.3 mg/kg Placebo : Placebo (up to 5mL)
Period Title: Overall Study
Started 10 13
Completed 10 13
Not Completed 0 0
Arm/Group Title Furosemide Placebo Total
Hide Arm/Group Description Furosemide : Furosemide 0.3 mg/kg Placebo : Placebo (up to 5mL) Total of all reporting groups
Overall Number of Baseline Participants 10 13 23
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 13 participants 23 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
8
  80.0%
10
  76.9%
18
  78.3%
>=65 years
2
  20.0%
3
  23.1%
5
  21.7%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 13 participants 23 participants
51  (16.6) 52.1  (15.6) 51.6  (15.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 13 participants 23 participants
Female
4
  40.0%
6
  46.2%
10
  43.5%
Male
6
  60.0%
7
  53.8%
13
  56.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 13 participants 23 participants
10 13 23
1.Primary Outcome
Title Acceptable vs. Unacceptable Brain Relaxation at Dural Opening
Hide 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
Time Frame just prior to dural opening for each subject
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Furosemide Placebo
Hide Arm/Group Description:
Furosemide : Furosemide 0.3 mg/kg
Placebo : Placebo (up to 5mL)
Overall Number of Participants Analyzed 10 13
Mean (Standard Error)
Unit of Measure: units on a scale 0-3
1.5  (.17) 1.3  (.13)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Furosemide Placebo
Hide Arm/Group Description Furosemide : Furosemide 0.3 mg/kg Placebo : Placebo (up to 5mL)
All-Cause Mortality
Furosemide Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Furosemide Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/13 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Furosemide Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/13 (0.00%) 
Recruitment was stopped at 23 subjects because of concern that the administration of furosemide was producing such a large diuresis that clinically significant and potentially unsafe hypovolemia and electrolyte abnormalities were developing.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. John F. Bebawy, Assistant Professor of Anesthesiology & Neurological Surgery
Organization: Northwestern University
Phone: 312-695-0061
EMail: j-bebawy@northwestern.edu
Layout table for additonal information
Responsible Party: John Bebawy, Northwestern University
ClinicalTrials.gov Identifier: NCT01054404     History of Changes
Other Study ID Numbers: STU00016126
First Submitted: January 20, 2010
First Posted: January 22, 2010
Results First Submitted: May 8, 2013
Results First Posted: August 2, 2013
Last Update Posted: August 2, 2013