Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2026-01-04 @ 8:11 PM
Study NCT ID:
NCT05400356
Status:
UNKNOWN
Last Update Posted:
2023-02-22
First Post:
2022-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dynamics of Immune Map and Outcomes After On-pump Cardiac Surgery: Protocol for a Prospective Cohort Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-18', 'studyFirstSubmitDate': '2022-05-27', 'studyFirstSubmitQcDate': '2022-05-27', 'lastUpdatePostDateStruct': {'date': '2023-02-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'composite outcome', 'timeFrame': 'From the beginning of surgery to 30 days after surgery or to discharge from hospital', 'description': 'the incidence of vital organ injury, which is defined as a composite measure, including postoperative death, vital organ dysfunction, and mechanical ventilation duration greater than 24 hours. And the vital organ dysfunction includes new kidney injury, long-term low cardiac output, severe liver function injury and neurological function injury.'}], 'secondaryOutcomes': [{'measure': 'Infection', 'timeFrame': 'From the beginning of surgery to 30 days after surgery or to discharge from hospital]'}, {'measure': 'MACCE', 'timeFrame': 'From the beginning of surgery to 30 days after surgery or to discharge from hospital]', 'description': 'including all-cause mortality, myocardial infarction, severe arrhythmias and stroke'}, {'measure': 'Acute lung injury', 'timeFrame': 'From the beginning of surgery to 30 days after surgery or to discharge from hospital]', 'description': 'Acute onset of bilateral infiltrates on the chest readiograph and hypoxaema(PaO2/Fi O2 ratio \\<300) in the absence of clincial evidence of left atrial hypertension'}, {'measure': 'Gastrointestinal complications', 'timeFrame': 'From the beginning of surgery to 30 days after surgery or to discharge from hospital', 'description': 'including gastrointestinal bleeding and intestinal ischemia'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['On-pump Valve Surgery or CABG']}, 'referencesModule': {'references': [{'pmid': '40270561', 'type': 'DERIVED', 'citation': 'Zheng Y, Ran Y, Wu J, Yang P, Liao X, Zhang J, Meng W, Gou D, Li L, Du L, Lin J. In vitro Validation of a Novel Disposable Remover to Remove Activated Leukocytes Generated During Cardiopulmonary Bypass: A Pilot Study. J Inflamm Res. 2025 Apr 18;18:5355-5370. doi: 10.2147/JIR.S503575. eCollection 2025.'}]}, 'descriptionModule': {'briefSummary': 'Although systemic inflammatory response induced by cardiopulmonary bypass is believed as one of main reasons for these adverse events, the involved mechanism is still unclear.This cohort study would include patients undergoing on-pump valve surgery or CABG. By detecting the changes of immune cell expression profile and inflammatory related substances in blood, the spatiotemporal change curve of immune function of patients is drawn for avoiding or treating adverse events.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Participants are recruited from West China Hospital of Sichuan University who would undergo cardiac surgery under CPB between June 2022 and December 2022', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* (1) participants aged over 18 years; (2) Participants who scheduled for valve replacement or valvuloplasty, coronary artery bypass under CPB.\n\nExclusion Criteria:\n\n* (1) participant with a cognitive or mental disorder who is unable to sign an informed consent form; (2) suffering from basic immune system and blood system diseases; (3) pregnancy; (4) preoperative radiotherapy and chemotherapy; (5) receive immunosuppressive drugs within six months;(6) Expected survival time less than 2 years;(7) participated in other intervention clinical trials within 30 days before operation.'}, 'identificationModule': {'nctId': 'NCT05400356', 'acronym': 'DIMOCS', 'briefTitle': 'Dynamics of Immune Map and Outcomes After On-pump Cardiac Surgery: Protocol for a Prospective Cohort Study', 'organization': {'class': 'OTHER', 'fullName': 'West China Hospital'}, 'officialTitle': 'Dynamics of Immune Map and Outcomes After On-pump Cardiac Surgery: Protocol for a Prospective Cohort Study', 'orgStudyIdInfo': {'id': 'WCH'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Complication group', 'description': 'Postoperative complications are defined as postoperative death, vital organ dysfunction, and mechanical ventilation duration greater than 24 hours.The vital organ dysfunction includes new developed acute kidney injury, long-term low cardiac output, severe liver function injury and neurological function injury.\n\nThe time of occurrence is defined as from the beginning of surgery to 30 days after surgery or to discharge from hospital.', 'interventionNames': ['Procedure: On-pump valve surgery or CABG']}, {'label': 'Non-complication group', 'description': 'Patients with none of postoperative complications which showed in Complication group.\n\nThe time of occurrence is defined as from the beginning of surgery to 30 days after surgery or to discharge from hospital.', 'interventionNames': ['Procedure: On-pump valve surgery or CABG']}], 'interventions': [{'name': 'On-pump valve surgery or CABG', 'type': 'PROCEDURE', 'description': 'On-pump valve surgery or coronary arterial bypass grafting', 'armGroupLabels': ['Complication group', 'Non-complication group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '610044', 'city': 'Chengdu', 'state': 'Sichuan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Tingting doctor Wang, Doctor', 'role': 'CONTACT', 'email': 'wangtingting@163.com', 'phone': '86-13606812800'}], 'facility': 'West China Hospital of Sichuan University', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}], 'centralContacts': [{'name': 'Jing Lin, doctor', 'role': 'CONTACT', 'email': '350576038@qq.com', 'phone': '+86 18980605853'}, {'name': 'Tingting Wang, doctor', 'role': 'CONTACT', 'email': 'wangtingting2045@163.com', 'phone': '+8613606812800'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'West China Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': '37#,Guoxue Road ,Chengdu, Sichuan Province, China', 'investigatorFullName': 'Lei Du', 'investigatorAffiliation': 'West China Hospital'}}}}