Furosemide vs Placebo for Brain Relaxation
Stopped early · Not applicable · Has a placebo group
Conditions studied: Brain Swelling, Brain Edema, Dehydration
In brief
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.
Key facts
- Study ID
- NCT01054404
- Run by
- Northwestern University
- People needed
- 23
- Starts
- 2010-02-01
- Expected to finish
- 2012-03-01
- Last updated by the study team
- 2013-08-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Inclusion criteria include:
- ASA PS I-III
- Age 18 or older
- Presenting for elective resection of primary or metastatic supratentorial brain tumor(s)
You may not qualify if…
- • 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
Where it is running
- Northwestern University — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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