Brain Edema, Brain Swelling, Dehydration
Conditions
Keywords
Brain Swelling, Brain Edema, Dehydration
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 1. = brain adequately relaxed under dura, acceptable 2. = brain slightly tense under dura, acceptable 3. = brain very tense under bulging dura, unacceptable
Interventions
DRUGFurosemide
Furosemide 0.3 mg/kg
DRUGPlacebo
Placebo (up to 5mL)
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptable vs. Unacceptable Brain Relaxation at Dural Opening | just prior to dural opening for each subject | 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 |
Countries
United States
Participant flow
Pre-assignment details
23 patients enrolled sequentially, no dropouts
Participants by arm
| Arm | Count |
|---|---|
| Furosemide Furosemide : Furosemide 0.3 mg/kg | 10 |
| Placebo Placebo : Placebo (up to 5mL) | 13 |
| Total | 23 |
Baseline characteristics
| Characteristic | Placebo | Furosemide | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 2 Participants | 5 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 8 Participants | 18 Participants |
| Age Continuous | 52.1 years STANDARD_DEVIATION 15.6 | 51 years STANDARD_DEVIATION 16.6 | 51.6 years STANDARD_DEVIATION 15.7 |
| Region of Enrollment United States | 13 participants | 10 participants | 23 participants |
| Sex: Female, Male Female | 6 Participants | 4 Participants | 10 Participants |
| Sex: Female, Male Male | 7 Participants | 6 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 10 | 0 / 13 |
| serious Total, serious adverse events | 0 / 10 | 0 / 13 |
Outcome results
Primary
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 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Furosemide | Acceptable vs. Unacceptable Brain Relaxation at Dural Opening | 1.5 units on a scale 0-3 | Standard Error 0.17 |
| Placebo | Acceptable vs. Unacceptable Brain Relaxation at Dural Opening | 1.3 units on a scale 0-3 | Standard Error 0.13 |