Acetazolamide to Prevent Post Operative CSF Leak

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University of Miami

Status and phase

Withdrawn
Phase 2

Conditions

Cerebrospinal Fluid Leak

Treatments

Drug: Acetazolamide

Study type

Interventional

Funder types

Other

Identifiers

NCT02902133
20150742

Details and patient eligibility

About

The purpose of this research is to test the use of Acetazolamide in preventing post-operative cerebrospinal fluid leak in patients having endoscopic skull base surgery (it is a surgery performed through the nose and sinus).

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Elective transsphenoidal resection of a tumor expected to result in an intraoperative high flow CSF leak; such tumors include craniopharyngioma, meningioma, and Rathke cleft cyst.
  • Elective transsphenoidal resection of a pituitary adenoma, with BMI >25, or with observed low or high flow CSF leak during surgery, conferring an elevated risk of postoperative CSF leak.
  • Patients who voluntarily sign Informed Consent
  • Male subjects and female subjects of childbearing potential and at risk for pregnancy must agree to use a highly effective method of contraception during study treatment and for at least 1 month after stopping study treatment. Male subjects should refrain from donating semen during treatment and 1 month after stopping treatment.

Exclusion criteria

  • Adults unable to consent
  • Individuals who are not yet adults (infants, children, teenagers)
  • Pregnant women
  • Prisoners
  • Patients with prior adverse reactions to acetazolamide or who are taking aspirin concomitantly (which may increase the risk of adverse reactions to acetazolamide)
  • Patients with moderate to severe chronic obstructive pulmonary disease (which may increase the risk of adverse effects of acetazolamide)
  • Acetazolamide therapy is contraindicated in situations in which sodium and/or potassium blood serum levels are depressed, in cases of marked kidney and liver disease or dysfunction, in suprarenal gland failure, and in hyperchloremic acidosis.
  • It is contraindicated in patients with cirrhosis because of the risk of development of hepatic encephalopathy
  • Sulfonamide allergy
  • Pregnant females, breastfeeding females, and males and females of childbearing potential who are unwilling or unable to use a highly effective method of contraception

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

0 participants in 1 patient group

Acetazolamide Arm
Other group
Description:
Acetazolamide 500 mg twice per day for 5 consecutive days post standard-of-care endoscopic skull base surgery
Treatment:
Drug: Acetazolamide

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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