Acetazolamide to Prevent Post Operative CSF Leak

Sponsor

University of Miami (Other)

Overall Status

Withdrawn

CT.gov ID

NCT02902133

Collaborator

(none)

Enrollment

Arm

Anticipated Duration (Months)

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
Cerebrospinal Fluid Leak	Drug: Acetazolamide	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

Anticipated Study Start Date :

Sep 1, 2016

Anticipated Primary Completion Date :

Sep 1, 2021

Anticipated Study Completion Date :

Sep 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Other: Acetazolamide Arm Acetazolamide 500 mg twice per day for 5 consecutive days post standard-of-care endoscopic skull base surgery	Drug: Acetazolamide Acetazolamide 500 mg by mouth twice per day for 5 days Other Names: Diamox

Arm

Intervention/Treatment

Other: Acetazolamide Arm

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

Drug: Acetazolamide

Acetazolamide 500 mg by mouth twice per day for 5 days

Other Names:

Diamox

Outcome Measures

Primary Outcome Measures

Incidence of CSF Leakage [30 days]
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 [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:

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

No locations specified.

Sponsors and Collaborators

University of Miami

Investigators

Principal Investigator: Ronald Benveniste, MD, University of Miami

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ronald Benveniste, Associate Professor, University of Miami

ClinicalTrials.gov Identifier:

NCT02902133

Other Study ID Numbers:

20150742

First Posted:

Sep 15, 2016

Last Update Posted:

Apr 21, 2020

Last Verified:

Apr 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

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.:

Additional relevant MeSH terms:

Cerebrospinal Fluid Leak

Acetazolamide

Study Results

No Results Posted as of Apr 21, 2020