Ignite Creation Date:
2025-12-24 @ 6:56 PM
Ignite Modification Date:
2026-01-02 @ 1:53 AM
Study NCT ID:
NCT03762057
Status:
UNKNOWN
Last Update Posted:
2018-12-03
First Post:
2018-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence, Risk Factors, and Prognostic Factors of Intraabdominal Hypertension and Abdominal Compartment Syndrome in Critically Ill Surgical Patients in Ramathibodi Hospital
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': 303}, 'targetDuration': '30 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-12-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2020-06-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-11-30', 'studyFirstSubmitDate': '2018-11-30', 'studyFirstSubmitQcDate': '2018-11-30', 'lastUpdatePostDateStruct': {'date': '2018-12-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of intraabdominal hypertension and abdominal compartment syndrome', 'timeFrame': 'Within 30 days of ICU admission', 'description': 'Prevalence of intraabdominal hypertension and abdominal compartment syndrome'}], 'secondaryOutcomes': [{'measure': 'Risk factors of intraabdominal hypertension and abdominal compartment syndrome', 'timeFrame': 'Within 30 days of ICU admission', 'description': 'Risk factors of intraabdominal hypertension and abdominal compartment syndrome'}, {'measure': 'Prognostic factors of death after developing intraabdominal hypertension and abdominal compartment syndrome', 'timeFrame': 'Within 30 days of ICU admission', 'description': 'Prognostic factors of death after developing intraabdominal hypertension and abdominal compartment syndrome'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Intraabdominal Hypertension', 'Abdominal Compartment Syndrome', 'Prevalence', 'Risk factors', 'ICU', 'Surgical'], 'conditions': ['Intraabdominal Hypertension', 'Abdominal Compartment Syndrome']}, 'descriptionModule': {'briefSummary': 'To identified prevalence, risk factors, and prognostic factors of IAH and ACS in surgical critically ill patients in institutional hospital', 'detailedDescription': "Every postoperative patients admitted to surgical ICU who meet inclusion criteria will be asked for informed consent. After obtained, intraabdominal pressure (IAP) will be measured through already placed Foley's catheter simultaneously with patients's data record. If patients don't have IAH or ICS, IAP will be measured daily until discharge from ICU or removal of Foley's catheter. If patients have IAH or ACS, IAP will be measured every 6-8 hours until IAP is less than 12 mmHg then it will be measures daily until discharge from ICU or removal of Foley's catheter. After completion of data collection, data will be analyzed accordingly."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All postoperative adult patients admitted to institutional surgical ICUs.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Postoperative patient admitted to surgical ICU\n* Age \\>/= 18\n* Foley's catheter in place\n\nExclusion Criteria:\n\n* Patient refusal\n* Underwent neo-bladder procedure\n* Need continuous bladder irrigation"}, 'identificationModule': {'nctId': 'NCT03762057', 'briefTitle': 'Prevalence, Risk Factors, and Prognostic Factors of Intraabdominal Hypertension and Abdominal Compartment Syndrome in Critically Ill Surgical Patients in Ramathibodi Hospital', 'organization': {'class': 'OTHER', 'fullName': 'Ramathibodi Hospital'}, 'officialTitle': 'Prevalence, Risk Factors, and Prognostic Factors of Intraabdominal Hypertension and Abdominal Compartment Syndrome in Critically Ill Surgical Patients in Ramathibodi Hospital', 'orgStudyIdInfo': {'id': 'CK999'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Surgical patients', 'description': 'All postoperative patients admitted to surgical ICU with foley catheter in place', 'interventionNames': ['Diagnostic Test: Intraabdominal pressure monitoring']}], 'interventions': [{'name': 'Intraabdominal pressure monitoring', 'type': 'DIAGNOSTIC_TEST', 'description': 'Classic manometry technique measurement once daily', 'armGroupLabels': ['Surgical patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10400', 'city': 'Ratchathewi', 'state': 'Bangkok', 'country': 'Thailand', 'contacts': [{'name': 'Cherdkiat Karnjanarachata, MD', 'role': 'CONTACT', 'email': 'chird_na@yahoo.com', 'phone': '+66-85-5774747'}, {'name': 'Cherdkiat Karnjanarachata, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ramathibodi Hospital', 'geoPoint': {'lat': 13.759, 'lon': 100.53358}}], 'centralContacts': [{'name': 'Cherdkiat Karnjanarachata, MD', 'role': 'CONTACT', 'email': 'chird_na@yahoo.com', 'phone': '+66-85-5774747'}, {'name': 'Kittikhun Narkasawet, MD', 'role': 'CONTACT', 'email': 'konkengsood@hotmail.com', 'phone': '+66-81-6820808'}], 'overallOfficials': [{'name': 'Cherdkiat Karnjanarachata, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of medicine, Ramathibodi Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ramathibodi Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Cherdkiat karnjanarachata', 'investigatorAffiliation': 'Ramathibodi Hospital'}}}}