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Acetazolamide for the Prevention of Post Operative CSF Leak

Primary Purpose

Cerebrospinal Fluid Leak

Status

Withdrawn

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Acetazolamide

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

University of Miami

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Acetazolamide Arm

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Incidence of suspected drug events

Treatment emergent adverse events as assessed by treating physician discretion.

Full Information

NCT ID

NCT04351061

First Posted

April 15, 2020

Last Updated

November 29, 2021

Sponsor

University of Miami

1. Study Identification

Unique Protocol Identification Number

NCT04351061

Brief Title

Acetazolamide for the Prevention of 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

November 2021

Overall Recruitment Status

Withdrawn

Why Stopped

No participants were identified per inclusion/exclusion criteria

Study Start Date

May 7, 2020 (Actual)

Primary Completion Date

November 24, 2021 (Actual)

Study Completion Date

November 24, 2021 (Actual)

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

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

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

Experimental

Arm Description

Participants in this arm will receive the Acetazolamide intervention for 7 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 7 consecutive days.

Primary Outcome Measure Information:

Title

Incidence of CSF Leakage

Description

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

Time Frame

30 days

Secondary Outcome Measure Information:

Title

Incidence of suspected drug 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

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, PhD

Organizational Affiliation

University of Miami

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Miami

City

Miami

State/Province

Florida

ZIP/Postal Code

33139

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Acetazolamide for the Prevention of Post Operative CSF Leak

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