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Acetazolamide for the Prevention of Post Operative CSF Leak

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04351061
Recruitment Status : Withdrawn (No participants were identified per inclusion/exclusion criteria)
First Posted : April 17, 2020
Last Update Posted : December 14, 2021
Sponsor:
Information provided by (Responsible Party):
Ronald Benveniste, University of Miami

Study Description
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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).

Condition or disease Intervention/treatment Phase
Cerebrospinal Fluid Leak Drug: Acetazolamide Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of Acetazolamide to Prevent Post Operative Cerebrospinal Fluid (CSF) Leak in Patients Undergoing Endoscopic Skull Base Surgery
Actual Study Start Date : May 7, 2020
Actual Primary Completion Date : November 24, 2021
Actual Study Completion Date : November 24, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: Diamox


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of CSF Leakage [ Time Frame: 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 :
  1. Incidence of suspected drug events [ Time Frame: 14 days ]
    Treatment emergent adverse events as assessed by treating physician discretion.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04351061


Locations
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United States, Florida
University of Miami
Miami, Florida, United States, 33139
Sponsors and Collaborators
University of Miami
Investigators
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Principal Investigator: Ronald Benveniste, MD, PhD University of Miami
More Information
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Responsible Party: Ronald Benveniste, Assistant Professor, University of Miami
ClinicalTrials.gov Identifier: NCT04351061    
Other Study ID Numbers: 20191265
First Posted: April 17, 2020    Key Record Dates
Last Update Posted: December 14, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Cerebrospinal Fluid Leak
Neurologic Manifestations
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Acetazolamide
 Anticonvulsants
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Diuretics
Natriuretic Agents
Physiological Effects of Drugs