Ignite Creation Date:
2025-12-24 @ 9:54 PM
Ignite Modification Date:
2025-12-25 @ 7:33 PM
Study NCT ID:
NCT04307732
Status:
UNKNOWN
Last Update Posted:
2020-10-14
First Post:
2020-03-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Preoperative Nutritional Status on the Postoperative Mortality and Morbidity in Patients Undergoing Valvular Heart Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2021-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-10-13', 'studyFirstSubmitDate': '2020-03-10', 'studyFirstSubmitQcDate': '2020-03-10', 'lastUpdatePostDateStruct': {'date': '2020-10-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'postoperative mortality according to peroperative nutritional status', 'timeFrame': '1 year after surgery', 'description': 'The association between preoperative nutritional status evaluated by the prognostic nutritional index (PNI), Geriatric Nutritional Risk Index (GNRI), and controlling nutritional status (CONUT) score and postoperative mortality is evaluated.'}, {'measure': 'postoperative mortality according to peroperative nutritional status', 'timeFrame': '2 year after surgery', 'description': 'The association between preoperative nutritional status evaluated by the prognostic nutritional index (PNI), Geriatric Nutritional Risk Index (GNRI), and controlling nutritional status (CONUT) score and postoperative mortality is evaluated.'}], 'secondaryOutcomes': [{'measure': 'predictive discrimination ability for mortality between PNI, GNRI, and CONUT', 'timeFrame': '1 year after surgery', 'description': 'The predictive discrimination abilities for mortality between PNI, GNRI, and CONUT score are compared.'}, {'measure': 'predictive discrimination ability for mortality between PNI, GNRI, and CONUT', 'timeFrame': '2 year after surgery', 'description': 'The predictive discrimination abilities for mortality between PNI, GNRI, and CONUT score are compared.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Patients Undergoing Valvular Heart Surgery']}, 'referencesModule': {'references': [{'pmid': '33551075', 'type': 'DERIVED', 'citation': 'Cho JS, Shim JK, Kim KS, Lee S, Kwak YL. Impact of preoperative nutritional scores on 1-year postoperative mortality in patients undergoing valvular heart surgery. J Thorac Cardiovasc Surg. 2022 Oct;164(4):1140-1149.e3. doi: 10.1016/j.jtcvs.2020.12.099. Epub 2021 Jan 5.'}]}, 'descriptionModule': {'briefSummary': 'The investigators investigated the clinical impacts of preoperative nutritional status on mortality in patients undergoing valvular heart surgery. Preoperative nutritional status was evaluated by the prognostic nutritional index (PNI), Geriatric Nutritional Risk Index (GNRI), and controlling nutritional status (CONUT) score. The primary outcome was the association between preoperative nutritional status evaluated by PNI, GNRI, and CONUT score and postoperative mortality. The predictive discrimination ability for mortality between PNI, GNRI, and CONUT were compared. Risk factors for mortality were identified.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Terticary care hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who underwent valvular heart surgery from January 2013 to February 2018\n\nExclusion Criteria:\n\n* Patients younger than 18 years\n* Patients undergoing combined congenital heart surgery\n* Patients undergoing transcatheter valve replacement'}, 'identificationModule': {'nctId': 'NCT04307732', 'briefTitle': 'Impact of Preoperative Nutritional Status on the Postoperative Mortality and Morbidity in Patients Undergoing Valvular Heart Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'officialTitle': 'Impact of Preoperative Nutritional Status on the Postoperative Mortality and Morbidity in Patients Undergoing Valvular Heart Surgery', 'orgStudyIdInfo': {'id': '4-2020-0024'}}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jin Sun Cho', 'role': 'CONTACT', 'email': 'chjs0214@yuhs.ac'}], 'facility': 'Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Jin Sun Cho', 'role': 'CONTACT', 'email': 'chjs0214@yuhs.ac', 'phone': '82-2-2228-4433'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}