Overview

Acetazolamide for the Prevention of Post Operative CSF Leak

Status:
Recruiting
Trial end date:
2022-05-31
Target enrollment:
0
Participant gender:
All
Summary
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).
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Miami
Treatments:
Acetazolamide
Criteria
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