Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2026-03-09 @ 9:19 AM
Study NCT ID:
NCT03876418
Status:
UNKNOWN
Last Update Posted:
2019-03-15
First Post:
2019-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Surveillance, Prevention and Treatment of Intra-abdominal Hypertension and Abdominal Compartment Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059325', 'term': 'Intra-Abdominal Hypertension'}], 'ancestors': [{'id': 'D003161', 'term': 'Compartment Syndromes'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 750}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2020-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-03-13', 'studyFirstSubmitDate': '2019-01-17', 'studyFirstSubmitQcDate': '2019-03-13', 'lastUpdatePostDateStruct': {'date': '2019-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality', 'timeFrame': '30 days', 'description': 'ICU Mortality'}], 'secondaryOutcomes': [{'measure': '% of bladder pressure measurements (feasibility)', 'timeFrame': '30 days', 'description': 'Number of eligible measurements recorded / Number of eligible measurements'}, {'measure': 'Length of stay', 'timeFrame': '30 days'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intra-Abdominal Hypertension', 'Abdominal Compartment Syndrome']}, 'descriptionModule': {'briefSummary': 'This study evaluates the efficacy of intensive surveillance, prevention and treatment of intra-abdominal hypertension in ICU patients. In the first two months patients will be screened and undergo usual care. In the following 10-months patients will have more intensive screening and active measures towards prevention and treatment according to best practices.', 'detailedDescription': "Elevated intra-abdominal pressures or intra-abdominal hypertension (IAH) has been shown to be common in all intensive care unit (ICU) patients (upwards of 50%) and has been suggested as the missing link in multi-organ dysfunction, and subsequently ICU mortality. Despite guidelines advocating prevention and surveillance of IAH, adherence remains low in most ICUs across North America and Europe.\n\nThe creation of the World Society of the Abdominal Compartment Syndrome (WSACS) in 2004 improved the recognition of IAH/ACS by intensivists. The first consensus guidelines from the WSACS were released in 2006, followed by a 2013 update. Additionally, clinical practice guidelines and recommendations for research were released in 2007 and 2009 respectively, which attempted to standardize research methods and reporting. Unfortunately, even in the 2013 guidelines only WEAK recommendations (by GRADE methodology) could be made regarding the efficacy of surveillance and treatment of IAH/ACS, citing a lack of high quality interventional trials.\n\nThe investigator's study aims to assess the feasibility of a larger multi-center interventional trial to investigate the efficacy of aggressive screening, prevention and treatment of IAH in ICU patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults (\\> 18 years of age)\n* Admitted to intensive care unit\n* Bladder catheter in-situ\n\nExclusion Criteria:\n\n* Death prior to first IAP pressure measurement\n* Pregnancy\n* Expected ICU discharge within 24 hours\n* Organ donor\n* Clinical care team or patient/substitute decision maker declines to enroll patient'}, 'identificationModule': {'nctId': 'NCT03876418', 'briefTitle': 'Surveillance, Prevention and Treatment of Intra-abdominal Hypertension and Abdominal Compartment Syndrome', 'organization': {'class': 'OTHER', 'fullName': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's"}, 'officialTitle': 'Surveillance, Prevention and Treatment of Intra-abdominal Hypertension and Abdominal Compartment Syndrome: A Single Center Prospective Cohort Study', 'orgStudyIdInfo': {'id': '100281'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Usual Care', 'description': 'Patients undergo twice daily measurement of intra-abdominal pressure. Clinicians manage patients according to usual care.'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Aggressive', 'description': 'Patients undergo aggressive surveillance (q6h) if intra-abdominal pressure is elevated as well as prevention and treatment according to protocol driven guidelines adapted from the World Society of the Abdominal Compartment. This may include nasogastric decompression, limiting fluid administration, drainage of ascites, paralysis and/or abdominal decompression.', 'interventionNames': ['Diagnostic Test: Intra-abdominal Pressure']}], 'interventions': [{'name': 'Intra-abdominal Pressure', 'type': 'DIAGNOSTIC_TEST', 'description': 'Aggressive screening, prevention and treatment of intra-abdominal hypertension', 'armGroupLabels': ['Aggressive']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Ian Ball, MD', 'role': 'CONTACT', 'email': 'Ian.Ball@lhsc.on.ca', 'phone': '519-685-8500', 'phoneExt': '71513'}], 'overallOfficials': [{'name': 'Ian Ball, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'London Health Sciences Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}