Ignite Creation Date:
2025-12-25 @ 12:09 AM
Ignite Modification Date:
2025-12-25 @ 10:09 PM
Study NCT ID:
NCT04670458
Status:
UNKNOWN
Last Update Posted:
2020-12-17
First Post:
2020-11-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Derivation of An In-Hospital Cardiac Arrest Prediction Model for Patients in Intensive Care Unit
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-12-10', 'studyFirstSubmitDate': '2020-11-26', 'studyFirstSubmitQcDate': '2020-12-10', 'lastUpdatePostDateStruct': {'date': '2020-12-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'In-Hospital Cardiac Arrest', 'timeFrame': 'Day 2', 'description': 'Cardiac arrest occurs during hospitalization'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Critically ill patients', 'In-Hospital Cardiac Arrest', 'Early recognition', 'Early warning score'], 'conditions': ['In-Hospital Cardiac Arrest']}, 'descriptionModule': {'briefSummary': 'Current studies have shown that hospitalized ICU patients have a high risk of IHCA, with an incidence of about 0.6-7.8%. Early prediction of the occurrence of IHCA in severe patients can provide early intervention, prevent the deterioration of the disease, and reduce the incidence of IHCA. Therefore, researchers wanted to verify the efficacy of MEWS, NEWS, and CART scores in predicting IHCA in ICU inpatients, and to establish an early-warning scoring model that could effectively predict the risk of IHCA occurrence in ICU inpatients during hospitalization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '14 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients hospitalized in the intensive care unit (ICU, CCU, RICU, EICU, NCU and DICU) of Qilu Hospital of Shandong University from January 1, 2017 to October 31, 2019 were selected.', 'healthyVolunteers': False, 'eligibilityCriteria': 'CA group\n\nInclusion Criteria:\n\n* Occurrence of IHCA\n* Hospital stay ≥48h.\n\nExclusion Criteria:\n\n* \\<14 years\n* Do Not Resuscitat\n* Patients hospitalized due to out-of-hospital cardiac arrest\n* Cardiac arrest occurs during the operation\n* The patients with implanted cardiac pacemaker suffered cardiac arrest due to instrument malfunction.\n\nCONTROL group\n\nInclusion Criteria:\n\n* Without IHCA\n* Hospital stay ≥48h\n\nExclusion Criteria:\n\n* \\<14 years\n* Leave hospital without medical advice'}, 'identificationModule': {'nctId': 'NCT04670458', 'briefTitle': 'Derivation of An In-Hospital Cardiac Arrest Prediction Model for Patients in Intensive Care Unit', 'organization': {'class': 'OTHER', 'fullName': 'Qilu Hospital of Shandong University'}, 'officialTitle': 'Derivation of An In-Hospital Cardiac Arrest Prediction Model for Patients in Intensive Care Unit', 'orgStudyIdInfo': {'id': 'IHCA-EWS-QLH'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CA group', 'description': 'Patients with In-Hospital Cardiac Arrest', 'interventionNames': ['Other: no intervention']}, {'label': 'CONTROL group', 'description': 'Patients without In-Hospital Cardiac Arrest', 'interventionNames': ['Other: no intervention']}], 'interventions': [{'name': 'no intervention', 'type': 'OTHER', 'description': 'no intervention', 'armGroupLabels': ['CA group', 'CONTROL group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '250012', 'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wentao Sang', 'role': 'CONTACT', 'email': '752318151@qq.com', 'phone': '15153187102'}, {'name': 'Feng Xu', 'role': 'CONTACT', 'email': 'xufengsdu@126.com', 'phone': '18560083066'}], 'facility': 'Qilu Hospital of Shandong University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}], 'centralContacts': [{'name': 'Wentao Sang', 'role': 'CONTACT', 'email': '752318151@qq.com', 'phone': '15153187102'}, {'name': 'Feng Xu', 'role': 'CONTACT', 'email': 'xufengsdu@126.com', 'phone': '18560083066'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qilu Hospital of Shandong University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}