Ignite Creation Date:
2025-12-24 @ 7:25 PM
Ignite Modification Date:
2026-03-24 @ 7:57 AM
Study NCT ID:
NCT05871203
Status:
UNKNOWN
Last Update Posted:
2023-05-23
First Post:
2023-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Changes in Gene Expression and Prognosis of Blood Immune Cells After Cardiopulmonary Bypass Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001483', 'term': 'Base Sequence'}], 'ancestors': [{'id': 'D015394', 'term': 'Molecular Structure'}, {'id': 'D001669', 'term': 'Biochemical Phenomena'}, {'id': 'D055598', 'term': 'Chemical Phenomena'}, {'id': 'D040342', 'term': 'Genetic Structures'}, {'id': 'D055614', 'term': 'Genetic Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05-17', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-07-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-15', 'studyFirstSubmitDate': '2023-05-15', 'studyFirstSubmitQcDate': '2023-05-15', 'lastUpdatePostDateStruct': {'date': '2023-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative acute kidney injury', 'timeFrame': 'Within 48 hours after surgery', 'description': 'SCr was elevated ≥ 26.5 micromol/L or 1.5 times the baseline for SCr ≥ or urine output \\< 0.5 mL/kg/hour within 6 hours within 48 hours'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute kidney injury', 'Cardiopulmonary bypass', 'gene expression'], 'conditions': ['Acute Kidney Injury']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to learn about the changes in gene expression in blood immune cells in after cardiac surgery with cardiopulmonary bypass.The main question it aims to answer is: What specific gene expression changes predict kidney damage after cardiac surgery with cardiopulmonary bypass. Participants received conventional treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients undergoing elective major cardiac surgery under cardiopulmonary bypass', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\) Age≥ 18 years old; 2) Cardiopulmonary bypass descending valve replacement (molding), or coronary artery bypass grafting, or macrovascular surgery.\n\nExclusion Criteria:\n\n* 1\\) any cognitive or mental impairment that is unable to sign the informed consent form; 2) Have basic immune system and blood system diseases; 3) pregnancy; 4) Receiving radiotherapy and chemotherapy before surgery; 5) Receiving immunosuppressive drugs within six months; 6) Have participated in other interventional clinical trials within 30 days before surgery.\n\nExit Criteria:\n\n1. Incomplete surgery;\n2. Secondary transfer in the operating room;\n3. Automatically request to terminate the test.'}, 'identificationModule': {'nctId': 'NCT05871203', 'briefTitle': 'Changes in Gene Expression and Prognosis of Blood Immune Cells After Cardiopulmonary Bypass Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'Changes in Gene Expression and Prognosis of Blood Immune Cells After Cardiopulmonary Bypass Surgery', 'orgStudyIdInfo': {'id': '2023-0359'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Postoperative acute kidney injury', 'interventionNames': ['Other: Gene sequencing']}, {'label': 'Postoperative non-acute kidney injury', 'interventionNames': ['Other: Gene sequencing']}], 'interventions': [{'name': 'Gene sequencing', 'type': 'OTHER', 'description': 'Participants were taken blood samples for gene sequencing at three time periods: before, after, and 24 hours after the end of the surgery', 'armGroupLabels': ['Postoperative acute kidney injury', 'Postoperative non-acute kidney injury']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310000', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Min Yan, Doctor', 'role': 'CONTACT', 'email': 'zryanmin@zju.edu.cn', 'phone': '18895386675'}, {'name': 'Min Yan, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Second Affiliated Hospital of Zhejiang University anesthesiology department', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}