Ignite Creation Date:
2025-12-24 @ 12:37 PM
Ignite Modification Date:
2026-01-03 @ 11:05 PM
Study NCT ID:
NCT04351061
Status:
WITHDRAWN
Last Update Posted:
2021-12-14
First Post:
2020-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acetazolamide for the Prevention of Post Operative CSF Leak
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065634', 'term': 'Cerebrospinal Fluid Leak'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000086', 'term': 'Acetazolamide'}], 'ancestors': [{'id': 'D013830', 'term': 'Thiadiazoles'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'No participants were identified per inclusion/exclusion criteria', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2020-05-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2021-11-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-29', 'studyFirstSubmitDate': '2020-04-15', 'studyFirstSubmitQcDate': '2020-04-15', 'lastUpdatePostDateStruct': {'date': '2021-12-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of CSF Leakage', 'timeFrame': '30 days', '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'}], 'secondaryOutcomes': [{'measure': 'Incidence of suspected drug events', 'timeFrame': '14 days', 'description': 'Treatment emergent adverse events as assessed by treating physician discretion.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cerebrospinal Fluid Leak']}, 'descriptionModule': {'briefSummary': '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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n* 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.\n* Patients who voluntarily sign Informed Consent\n* 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.\n\nExclusion Criteria:\n\n* Adults unable to consent\n* Individuals who are not yet adults (infants, children, teenagers)\n* Pregnant women\n* Prisoners\n* Patients with prior adverse reactions to acetazolamide or who are taking aspirin concomitantly (which may increase the risk of adverse reactions to acetazolamide)\n* Patients with moderate to severe chronic obstructive pulmonary disease (which may increase the risk of adverse effects of acetazolamide)\n* 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.\n* It is contraindicated in patients with cirrhosis because of the risk of development of hepatic encephalopathy\n* Sulfonamide allergy\n* Pregnant females, breastfeeding females, and males and females of childbearing potential who are unwilling or unable to use a highly effective method of contraception'}, 'identificationModule': {'nctId': 'NCT04351061', 'briefTitle': 'Acetazolamide for the Prevention of Post Operative CSF Leak', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'Pilot Study of Acetazolamide to Prevent Post Operative Cerebrospinal Fluid (CSF) Leak in Patients Undergoing Endoscopic Skull Base Surgery', 'orgStudyIdInfo': {'id': '20191265'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Acetazolamide Arm', 'description': 'Participants in this arm will receive the Acetazolamide intervention for 7 consecutive days post standard of care endoscopic skull base surgery.', 'interventionNames': ['Drug: Acetazolamide']}], 'interventions': [{'name': 'Acetazolamide', 'type': 'DRUG', 'otherNames': ['Diamox'], 'description': 'Acetazolamide 500 mg by mouth twice per day for 7 consecutive days.', 'armGroupLabels': ['Acetazolamide Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33139', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'overallOfficials': [{'name': 'Ronald Benveniste, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Miami', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Ronald Benveniste', 'investigatorAffiliation': 'University of Miami'}}}}