Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:37 PM
Ignite Modification Date:
2025-12-24 @ 12:37 PM
NCT ID:
NCT04351061
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04351061
Study Brief:
Protocol Section:
NCT04351061