Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2025-12-27 @ 7:43 AM
Study NCT ID:
NCT04848168
Status:
COMPLETED
Last Update Posted:
2022-09-07
First Post:
2021-04-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of PRISM III, PIM2 and PELOD Scoring Systems
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006330', 'term': 'Heart Defects, Congenital'}], 'ancestors': [{'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 116}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-05', 'studyFirstSubmitDate': '2021-04-09', 'studyFirstSubmitQcDate': '2021-04-13', 'lastUpdatePostDateStruct': {'date': '2022-09-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'evaluate the success of PRISMIII, PIM2 and PELOD scoring systems in predicting mortality and morbidity', 'timeFrame': '3 months', 'description': 'Patients younger than 18 years of age who had undergone congenital heart surgery were evaluated on the first postoperative day in the ICU and parameters were recorded. PRISMIII and PELOD scores were calculated using the most abnormal values in the first 24 hours, and PIM2 score was calculated using the data within the first hour.'}, {'measure': 'morbidity indicators', 'timeFrame': '3 months', 'description': 'Morbidity indicators were determined as the length of ICU stay, total hospital stay, re-intubation, surgical revision, complications and re-admission to the ICU.'}, {'measure': 'clinical outcomes', 'timeFrame': '3 months', 'description': 'Clinical outcomes were determined as 7-day mortality and 30-day mortality.'}], 'secondaryOutcomes': [{'measure': 'to evaluate the relationship of these systems with the STAT(STS-EACTS CHS Mortality Score) category', 'timeFrame': '3 months', 'description': 'STAT category was determined according to the surgical procedure.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PRISM III', 'PIM2', 'PELOD', 'STAT', 'mortality', 'congenital heart disease'], 'conditions': ['Congenital Heart Disease']}, 'descriptionModule': {'briefSummary': 'PRISMIII(Pediatric Risk of Mortality III), PIM2(Pediatric Index of Mortality 2) and PELOD(Pediatric Logistic Organ Dysfunction) are frequently used for predicting mortality and morbidity in general pediatric ICUs(Intensive Care Units). However, the effectiveness of these scoring sistems in a specific group patients undergoing congenital heart surgery(CHS) is unknown. In this study, the investigators aimed primarily to evaluate the success of these scoring systems in predicting mortality and morbiditiy in this specific group and to compare the scoring systems with eachother, and secondly to evaluate the relationship of these systems with the STAT(STS-EACTS CHS Mortality Score) category'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Day', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients younger than 18 years of age who had undergone congenital heart surgery', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients younger than 18 years of age who had undergone congenital heart surgery\n\nExclusion Criteria:\n\n* emergency operations Patients staying in intensive care unit for less than 24 hours'}, 'identificationModule': {'nctId': 'NCT04848168', 'briefTitle': 'Comparison of PRISM III, PIM2 and PELOD Scoring Systems', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Antalya Training and Research Hospital'}, 'officialTitle': 'Comparison Of PRISM III, PIM2 And PELOD Scoring Systems In Predicting Mortality For Patients Undergoing Congenital Cardiac Surgery In Pediatric Intensive Care Unit', 'orgStudyIdInfo': {'id': 'Dr. Siyami Ersek TRH'}}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'siyami ersek TRH', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Antalya Training and Research Hospital', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital', 'class': 'OTHER'}, {'name': 'Haydarpasa Numune Training and Research Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Seyma Sayit', 'investigatorAffiliation': 'Haydarpasa Numune Training and Research Hospital'}}}}