Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2025-12-29 @ 6:53 PM
Study NCT ID:
NCT01351506
Status:
COMPLETED
Last Update Posted:
2014-11-07
First Post:
2011-05-09
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Body Weight Change to Surgical ICU Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D001836', 'term': 'Body Weight Changes'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kchittaw@gmail.com', 'phone': '+66815951259', 'title': 'Dr.Kaweesak Chittawatanarat', 'organization': 'Chiang Mai University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'up to 28 days after ICU admission', 'description': 'Events occurring within 28 days after ICU admission', 'eventGroups': [{'id': 'EG000', 'title': '</= 5%', 'description': 'Maximum weight change upto 7 days less than or equal to 5% of admission body weight', 'otherNumAtRisk': 306, 'otherNumAffected': 38, 'seriousNumAtRisk': 306, 'seriousNumAffected': 11}, {'id': 'EG001', 'title': '> 5%', 'description': 'Maximum weight change upto 7 days more than 5% of admission weight', 'otherNumAtRisk': 159, 'otherNumAffected': 37, 'seriousNumAtRisk': 159, 'seriousNumAffected': 19}], 'otherEvents': [{'term': 'Delirium', 'notes': 'Delirium at least 4 of following criteria: 1) consciousness alteration, 2) inattention, 3) disorientation, 4) hallucination- delusion- psychosis, 5) psychomotor agitation or retardation, 6) inappropriate speech or mood, and 7) symptom fluctuation.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 306, 'numEvents': 38, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 37, 'numAffected': 37}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Renal replacement therapy', 'notes': 'Require of renal replacement therapy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 306, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 19, 'numAffected': 19}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'In Hospital Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '306', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '</= 5%', 'description': 'Maximum weight change upto 7 days less than or equal to 5% of admission body weight'}, {'id': 'OG001', 'title': '> 5%', 'description': 'Maximum weight change upto 7 days more than 5% of admission weight'}], 'classes': [{'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'within 28 days after ICU admission to dead', 'description': '28 days mortality if patient still have be admitted in hospital.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Total 465 patients'}, {'type': 'SECONDARY', 'title': 'Re Intubation Within 72 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '306', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '</= 5%', 'description': 'Maximum weight change upto 7 days less than or equal to 5% of admission body weight'}, {'id': 'OG001', 'title': '> 5%', 'description': 'Maximum weight change upto 7 days more than 5% of admission weight'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'ICU complications up to 28 days after ICU admission', 'description': 'Patient who need re-intubation within 72 hours', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All'}, {'type': 'SECONDARY', 'title': 'Acute Kidney Injury', 'denoms': [{'units': 'Participants', 'counts': [{'value': '306', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '</= 5%', 'description': 'Maximum weight change upto 7 days less than or equal to 5% of admission body weight'}, {'id': 'OG001', 'title': '> 5%', 'description': 'Maximum weight change upto 7 days more than 5% of admission weight'}], 'classes': [{'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Acute kidney injury', 'description': 'New acute kidney injury in ICU', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cohort Patient', 'description': 'A total of 602 patients as inclusion criteria between May 2011 and August 2012 were enrolled on the ICU admission (day 0). One hundred thirty seven patients were excluded due to a short stay in ICU or were not weighed a second time on day 1. The remainder of 465 patients were included and followed in this study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '602'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '465'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '137'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '395', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '465', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'ICU Survivors', 'description': 'Patients who survivors from ICU discharge status'}, {'id': 'BG001', 'title': 'ICU Non Survivors', 'description': 'Patients who non survivors from ICU discharge status'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000', 'lowerLimit': '49', 'upperLimit': '72'}, {'value': '53', 'groupId': 'BG001', 'lowerLimit': '45', 'upperLimit': '74'}, {'value': '60', 'groupId': 'BG002', 'lowerLimit': '49', 'upperLimit': '74'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '148', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '179', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '247', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '286', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 465}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-03', 'studyFirstSubmitDate': '2011-05-09', 'resultsFirstSubmitDate': '2014-11-03', 'studyFirstSubmitQcDate': '2011-05-10', 'lastUpdatePostDateStruct': {'date': '2014-11-07', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-11-03', 'studyFirstPostDateStruct': {'date': '2011-05-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-11-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'In Hospital Mortality', 'timeFrame': 'within 28 days after ICU admission to dead', 'description': '28 days mortality if patient still have be admitted in hospital.'}], 'secondaryOutcomes': [{'measure': 'Re Intubation Within 72 Hours', 'timeFrame': 'ICU complications up to 28 days after ICU admission', 'description': 'Patient who need re-intubation within 72 hours'}, {'measure': 'Acute Kidney Injury', 'timeFrame': 'Acute kidney injury', 'description': 'New acute kidney injury in ICU'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Body weight', 'Body mass index', 'Weight change', 'ICU outcomes'], 'conditions': ['Body Weight', 'Weight Change']}, 'referencesModule': {'references': [{'pmid': '26251605', 'type': 'DERIVED', 'citation': 'Chittawatanarat K, Pichaiya T, Chandacham K, Jirapongchareonlap T, Chotirosniramit N. Fluid accumulation threshold measured by acute body weight change after admission in general surgical intensive care units: how much should be concerning? Ther Clin Risk Manag. 2015 Jul 27;11:1097-106. doi: 10.2147/TCRM.S86409. eCollection 2015.'}]}, 'descriptionModule': {'briefSummary': 'Aims of study\n\n1. Effect of daily weight change upto 7 days from ICU admission to outcome of treatment in 28 days\n2. Determination cut point of maximum weight change to outcome treatment', 'detailedDescription': 'Study type : Prospective observational study Location : General surgical intensive care unit Inclusion criteria : All admission patient with expected survive more than 24 hours Exclusion criteria : Patient died within 24 hours or who could not be weighed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All admitted ICU patients which expected survive more than 24 hours.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All admitted ICU patients expected survive more than 24 hours\n\nExclusion Criteria:\n\n* All expected ICU patients survive less than 24 hours\n* All patient cannot be weighed.'}, 'identificationModule': {'nctId': 'NCT01351506', 'briefTitle': 'Effect of Body Weight Change to Surgical ICU Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'Chiang Mai University'}, 'officialTitle': 'Effect and Determinant Level of Admission Body Weight and Daily Weight Change and Prognoses of Critically and High Risk Surgical Patients', 'orgStudyIdInfo': {'id': '10FEB010924'}}, 'contactsLocationsModule': {'locations': [{'zip': '50200', 'city': 'Muang Chiang Mai', 'state': 'Chiang Mai', 'country': 'Thailand', 'facility': 'Department of Surgery, Faculty of Medicine, Maharaj Nakorn Chiang Mai hospital'}], 'overallOfficials': [{'name': 'Kaweesak Chittawatanarat Assistant Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chaing Mai University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chiang Mai University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Department of Surgery', 'investigatorFullName': 'Kaweesak Chittawatanarat', 'investigatorAffiliation': 'Chiang Mai University'}}}}