Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2026-02-23 @ 8:09 PM
Study NCT ID:
NCT02514135
Status:
COMPLETED
Last Update Posted:
2018-08-27
First Post:
2015-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intra-abdominal Hypertension in Critically Ill Patients
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 286}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2016-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-24', 'studyFirstSubmitDate': '2015-07-30', 'studyFirstSubmitQcDate': '2015-07-30', 'lastUpdatePostDateStruct': {'date': '2018-08-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-08-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality', 'timeFrame': 'While patient in-hospital, expected stay one week on average', 'description': 'As measured prospectively by patient death in the ICU'}], 'secondaryOutcomes': [{'measure': 'Length of stay', 'timeFrame': 'While patient in-hospital, expected stay one week on average', 'description': 'Measured prospectively from date of admission to ICU to death, or discharge from ICU'}, {'measure': 'Abdominal decompression', 'timeFrame': 'While patient in-hospital, expected stay one week on average', 'description': 'Midline laparotomy for abdominal compartment syndrome'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Intra-Abdominal Hypertension', 'Abdominal Compartment Syndrome']}, 'referencesModule': {'references': [{'pmid': '23673399', 'type': 'BACKGROUND', 'citation': "Kirkpatrick AW, Roberts DJ, De Waele J, Jaeschke R, Malbrain ML, De Keulenaer B, Duchesne J, Bjorck M, Leppaniemi A, Ejike JC, Sugrue M, Cheatham M, Ivatury R, Ball CG, Reintam Blaser A, Regli A, Balogh ZJ, D'Amours S, Debergh D, Kaplan M, Kimball E, Olvera C; Pediatric Guidelines Sub-Committee for the World Society of the Abdominal Compartment Syndrome. Intra-abdominal hypertension and the abdominal compartment syndrome: updated consensus definitions and clinical practice guidelines from the World Society of the Abdominal Compartment Syndrome. Intensive Care Med. 2013 Jul;39(7):1190-206. doi: 10.1007/s00134-013-2906-z. Epub 2013 May 15."}]}, 'descriptionModule': {'briefSummary': 'The aim of the proposed study is to determine the incidence and prevalence of intra-abdominal hypertension and abdominal compartment syndrome in consecutive intensive care admissions using broad inclusion criteria.', 'detailedDescription': 'Increased pressure within the abdominal cavity is particularly common in intensive care patients and has been shown to be an independent risk-factor for mortality in this patient population. The quoted rates of intra-abdominal hypertension of range anywhere from 20-60% are dependent on the population of patient studied. The prospective observational studies performed to date have been underpowered, used strict inclusion/exclusion criteria or were performed prior to consensus guidelines on the definition and measurement of intra-abdominal pressure and hypertension.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All adults (\\>18 years of age) admitted to the intensive care unit at Victoria Hospital, London, Ontario who have a Foley catheter in-situ', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Foley catheter in-situ on admission\n\nExclusion Criteria:\n\n* Contra-indication to bladder pressure measurement\n* Home service asked that patient is not included\n* Death within 24 priors of admission before bladder pressure measured\n* No bladder pressure performed within 24 hours of admission\n* Consent refused or unable to be obtained (lack of SDM, patient unable to provide)'}, 'identificationModule': {'nctId': 'NCT02514135', 'briefTitle': 'Intra-abdominal Hypertension in Critically Ill Patients', 'organization': {'class': 'OTHER', 'fullName': 'Western University, Canada'}, 'officialTitle': 'Intra-abdominal Hypertension in Critically Ill Patients', 'orgStudyIdInfo': {'id': 'WesternUCanada'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Elevated Intra-abdominal Pressure', 'description': 'Patients with intra-abdominal pressure \\> 12 mmHg at any time throughout admission', 'interventionNames': ['Other: No intervention']}, {'label': 'Normal Intra-abdominal Pressure', 'description': 'Patients with intra-abdominal pressure \\< 12 mmHg throughout admission', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'armGroupLabels': ['Elevated Intra-abdominal Pressure', 'Normal Intra-abdominal Pressure']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N6K 1C2', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Victoria Hospital', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}], 'overallOfficials': [{'name': 'Kelly N Vogt, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Western University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Western University, Canada', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident', 'investigatorFullName': 'Patrick Murphy', 'investigatorAffiliation': 'Western University, Canada'}}}}