Furosemide vs Placebo for Brain Relaxation (NCT01054404) | Clinical Trial Compass
TerminatedNot Applicable
Furosemide vs Placebo for Brain Relaxation
Stopped: Concern for volume depletion and electrolyte abnormalities in furosemide arm.
United States23 participantsStarted 2010-02
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Acceptable vs. Unacceptable Brain Relaxation at Dural Opening
Timeframe: just prior to dural opening for each subject