Trial Information
The Effect of Furosemide Versus Placebo on Brain Relaxation and Incidence of Significant Intravascular Volume Depletion in Human Subjects Receiving Mannitol
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
acceptable vs. unacceptable brain relaxation at dural opening
Outcome Time Frame:
134 patients enrolled, 266 patients enrolled, 400 patients enrolled
Safety Issue:
No
Principal Investigator
John F Bebawy, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Northwestern University
Authority:
United States: Institutional Review Board
Study ID:
STU00016126
NCT ID:
NCT01054404
Start Date:
February 2010
Completion Date:
March 2012
Related Keywords:
- Brain Swelling
- Brain Edema
- Dehydration
- Brain Swelling
- Brain Edema
- Dehydration
- Brain Edema
- Dehydration
- Edema
Name | Location |
Northwestern University |
Chicago, Illinois 60611 |