Acetazolamide for the Prevention of Post Operative CSF Leak

Phase 2

Withdrawn

• Conditions: Cerebrospinal Fluid Leak
• Interventions: Drug: Acetazolamide

• Registration Number: NCT04351061
• Lead Sponsor: University of Miami

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-15
• Study First Submitted QC: 2020-04-15
• Study First Posted: 2020-04-17
• Study Start: 2020-05-07
• Status Verified: 2021-11
• Primary Completion: 2021-11-24
• Study Completion: 2021-11-24
• Last Update Submitted: 2021-11-29
• Last Update Posted: 2021-12-14

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Acetazolamide Arm	Acetazolamide	Participants in this arm will receive the Acetazolamide intervention for 7 consecutive days post standard of care endoscopic skull base surgery.

Primary Outcome Measures

Name	Time	Method
Incidence of CSF Leakage	30 days	Occurrence of post operative CSF leak within 30 days of surgery confirmed on clinical examination as well on CT scan, endoscopic evaluation or confirmation via beta transferrin testing

Secondary Outcome Measures

Name	Time	Method
Incidence of suspected drug events	14 days	Treatment emergent adverse events as assessed by treating physician discretion.

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States