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Acetazolamide for the Prevention of Post Operative CSF Leak

Sponsor
University of Miami (Other)
Overall Status
Withdrawn
CT.gov ID
NCT04351061
Collaborator
(none)
0
Enrollment
1
Location
1
Arm
18.6
Actual Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

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
Phase 2

Study Design

Study Type:
Interventional
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 :
Nov 24, 2021
Actual Study Completion Date :
Nov 24, 2021

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Incidence of suspected drug events [14 days]

      Treatment emergent adverse events as assessed by treating physician discretion.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 University of Miami Miami Florida United States 33139

    Sponsors and Collaborators

    • University of Miami

    Investigators

    • Principal Investigator: Ronald Benveniste, MD, PhD, University of Miami

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ronald Benveniste, Assistant Professor, University of Miami
    ClinicalTrials.gov Identifier:
    NCT04351061
    Other Study ID Numbers:
    • 20191265
    First Posted:
    Apr 17, 2020
    Last Update Posted:
    Dec 14, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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:
    Cerebrospinal Fluid Leak
    Acetazolamide

    Study Results

    No Results Posted as of Dec 14, 2021