Acetazolamide for the Prevention of Post Operative CSF Leak

Pilot Study of Acetazolamide to Prevent Post Operative Cerebrospinal Fluid (CSF) Leak in Patients Undergoing Endoscopic Skull Base Surgery

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).

Study Overview

• Status: Withdrawn
• Conditions: Cerebrospinal Fluid Leak
• Intervention / Treatment: Drug: Acetazolamide

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33139
      • University of Miami

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acetazolamide Arm; Participants in this arm will receive the Acetazolamide intervention for 7 consecutive days post standard of care endoscopic skull base surgery.	Drug: Acetazolamide; Acetazolamide 500 mg by mouth twice per day for 7 consecutive days.; Other Names: Diamox

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of CSF Leakage	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	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of suspected drug events	Treatment emergent adverse events as assessed by treating physician discretion.	14 days

Collaborators and Investigators

• Sponsor: University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2020
• Primary Completion (Actual): November 24, 2021
• Study Completion (Actual): November 24, 2021

Study Registration Dates

• First Submitted: April 15, 2020
• First Submitted That Met QC Criteria: April 15, 2020
• First Posted (Actual): April 17, 2020

Study Record Updates

• Last Update Posted (Actual): December 14, 2021
• Last Update Submitted That Met QC Criteria: November 29, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Cerebrospinal Fluid Leak; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Carbonic Anhydrase Inhibitors; Natriuretic Agents; Diuretics; Anticonvulsants; Acetazolamide
• Other Study ID Numbers: 20191265

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No