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Acetazolamide to Prevent Post Operative CSF Leak

Primary Purpose

Cerebrospinal Fluid Leak

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Acetazolamide
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebrospinal Fluid Leak

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Acetazolamide Arm

    Arm Description

    Acetazolamide 500 mg twice per day for 5 consecutive days post standard-of-care endoscopic skull base surgery

    Outcomes

    Primary Outcome Measures

    Incidence of CSF Leakage
    Occurrence of postoperative CSF leak within 30 days of surgery confirmed on clinical exam as well as on CT scan, endoscopic visualization, or confirmation via beta transferrin testing.

    Secondary Outcome Measures

    Incidence of suspected drug adverse events
    Treatment emergent adverse events as assessed by treating physician discretion.

    Full Information

    First Posted
    April 28, 2016
    Last Updated
    April 17, 2020
    Sponsor
    University of Miami
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02902133
    Brief Title
    Acetazolamide to Prevent Post Operative CSF Leak
    Official Title
    Pilot Study of Acetazolamide to Prevent Post Operative Cerebrospinal Fluid (CSF) Leak in Patients Undergoing Endoscopic Skull Base Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2020
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    No participants were identified per inclusion/exclusion criteria
    Study Start Date
    September 1, 2016 (Anticipated)
    Primary Completion Date
    September 1, 2021 (Anticipated)
    Study Completion Date
    September 1, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Miami

    4. Oversight

    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
    Data Monitoring Committee
    No

    5. 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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cerebrospinal Fluid Leak

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Acetazolamide Arm
    Arm Type
    Other
    Arm Description
    Acetazolamide 500 mg twice per day for 5 consecutive days post standard-of-care endoscopic skull base surgery
    Intervention Type
    Drug
    Intervention Name(s)
    Acetazolamide
    Other Intervention Name(s)
    Diamox
    Intervention Description
    Acetazolamide 500 mg by mouth twice per day for 5 days
    Primary Outcome Measure Information:
    Title
    Incidence of CSF Leakage
    Description
    Occurrence of postoperative CSF leak within 30 days of surgery confirmed on clinical exam as well as on CT scan, endoscopic visualization, or confirmation via beta transferrin testing.
    Time Frame
    30 days
    Secondary Outcome Measure Information:
    Title
    Incidence of suspected drug adverse events
    Description
    Treatment emergent adverse events as assessed by treating physician discretion.
    Time Frame
    14 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ronald Benveniste, MD
    Organizational Affiliation
    University of Miami
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Acetazolamide to Prevent Post Operative CSF Leak

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