Acetazolamide to Prevent Post Operative CSF Leak | NCT02902133

Studies
Acetazolamide to Prevent Post Operative CSF Leak

NCT02902133

Sponsor

University of Miami

Status

Withdrawn

Last Update Posted

Apr 21, 2020Actual

Enrollment

0Actual

Phase

Phase 2

Conditions

Cerebrospinal Fluid Leak

Interventions

Acetazolamide

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2020

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

No participants were identified per inclusion/exclusion criteria

Expanded Access Info

Start Date

Sep 1, 2016Estimated

Primary Completion Date

Sep 1, 2021Estimated

Completion Date

Sep 1, 2021Estimated

First Submitted Date

Apr 28, 2016

First Submission Date that Met QC Criteria

Sep 9, 2016

First Posted Date

Sep 15, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 17, 2020

Last Update Posted Date

Apr 21, 2020Actual

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Acetazolamide Arm	Other	Acetazolamide 500 mg twice per day for 5 consecutive days post standard-of-care endoscopic skull base surgery	Drug: Acetazolamide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Acetazolamide	Drug	Acetazolamide 500 mg by mouth twice per day for 5 days	Acetazolamide Arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	30 days

Secondary Outcomes

Measure	Description	Time Frame
Incidence of suspected drug adverse events	Treatment emergent adverse events as assessed by treating physician discretion.	14 days

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D006259	Craniocerebral Trauma
D020196	Trauma, Nervous System

ID	Term
D013830	Thiadiazoles
D013844	Thiazoles
D013457	Sulfur Compounds
D009930	Organic Chemicals