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The Effect of Furosemide Versus Placebo on Brain Relaxation and Incidence of Significant Intravascular Volume Depletion in Human Subjects Receiving Mannitol


N/A
18 Years
N/A
Not Enrolling
Both
Brain Swelling, Brain Edema, Dehydration

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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 UniversityChicago, Illinois  60611