Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2026-01-01 @ 9:39 PM
Study NCT ID:
NCT06248359
Status:
RECRUITING
Last Update Posted:
2025-04-04
First Post:
2024-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Association Between Postoperative Administration of L-Arginine and CSA-AKI
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 7000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-02', 'studyFirstSubmitDate': '2024-01-24', 'studyFirstSubmitQcDate': '2024-01-31', 'lastUpdatePostDateStruct': {'date': '2025-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'incidence of postoperative AKI', 'timeFrame': 'from the time of end of surgery until time of documented hospital discharge or time of death, whichever came first, assessed up to 30 days', 'description': 'Serum Creatinine Criteria:\n\nIncrease in Serum Creatinine:\n\nAn absolute increase in serum creatinine of 0.3 mg/dL (26.5 µmol/L) within 48 hours.\n\nOR a percentage increase in serum creatinine of ≥50% within 7 days. These criteria are relative to the baseline creatinine level, which is usually the recent preadmission value.\n\nUrine Output Criteria:\n\nOliguria, defined as a urine output \\<0.5 mL/kg/h for more than 6 hours. OR anuria, defined as a urine output \\<100 mL in 24 hours.'}], 'secondaryOutcomes': [{'measure': 'Renal failure', 'timeFrame': 'from the time of end of surgery until time of documented hospital discharge or time of death, whichever came first, assessed up to 30 days', 'description': 'KDIGO defined AKI stage ≥ 2, or if dialysis is required for newly developed conditions\n\nKDIGO classifies AKI into three stages based on the severity:\n\nStage 2:\n\nIncrease in serum creatinine of 2.0 to 2.9 times baseline OR Urine output \\<0.5 mL/kg/h for ≥12 hours.\n\nStage 3:\n\nIncrease in serum creatinine of 3.0 times baseline OR Increase in serum creatinine to ≥4.0 mg/dL OR Initiation of renal replacement therapy (RRT) OR Urine output \\<0.3 mL/kg/h for ≥24 hours OR anuria for ≥12 hours.'}, {'measure': 'in-hospital mortality', 'timeFrame': 'from the time of end of surgery until time of documented hospital discharge or time of death, whichever came first, assessed up to 30 days', 'description': 'all-cause postoperative deaths observed'}, {'measure': 'length of in-hospital stay', 'timeFrame': 'from the time of end of surgery until time of documented hospital discharge or time of death, whichever came first, assessed up to 30 days', 'description': 'postoperative stay until discharge or death'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Kidney Injury']}, 'descriptionModule': {'briefSummary': 'To investigate the association between the the early administration of L-Arginine after CPB-assisted cardiac surgery and the incidence of CS-AKI in adult patients. To test if it can reduce the incidence of post-operative AKI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients who were admitted to the ICU after cardiac surgery with CPB.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients (over 18 years)\n* underwent CPB assisted cardiac surgery\n* admitted to ICU\n\nExclusion Criteria:\n\n* congenital heart disease\n* underwent deep hypothermic circulatory arrest (DHCA)\n* with glomerular filtration rate (eGFR) below 30 mL/min/1.73 m²'}, 'identificationModule': {'nctId': 'NCT06248359', 'briefTitle': 'Association Between Postoperative Administration of L-Arginine and CSA-AKI', 'organization': {'class': 'OTHER', 'fullName': 'Xijing Hospital'}, 'officialTitle': 'Association Between Early Postoperative L-Arginine Administration and Acute Kidney Injury Following Cardiac Surgery', 'orgStudyIdInfo': {'id': 'KY20232170-C-1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Arginine Use', 'description': 'At least one dose of L-arginie was administered in the early postoperative stage', 'interventionNames': ['Drug: L-Arginine hydrochloride']}, {'label': 'Without Arginine', 'description': 'No L-arginie was administered'}], 'interventions': [{'name': 'L-Arginine hydrochloride', 'type': 'DRUG', 'description': 'Postoperative administration of L-Arginine hydrochloride before incidence of CS-AKI', 'armGroupLabels': ['Arginine Use']}]}, 'contactsLocationsModule': {'locations': [{'zip': '710032', 'city': "Xi'an", 'state': 'Shaanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chong Lei, MD & phD', 'role': 'CONTACT', 'email': 'crystalleichong@126.com', 'phone': '86-18629011362'}, {'name': 'lini Wang, MD', 'role': 'CONTACT', 'email': 'wangln238@163.com', 'phone': '86-15209234508'}], 'facility': 'Xijing Hospital', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'centralContacts': [{'name': 'Ziyu Zheng', 'role': 'CONTACT', 'email': 'zhengziyu@126.com', 'phone': '+86-13228082320'}], 'overallOfficials': [{'name': 'Chong Lei', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Xijing Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xijing Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Chong Lei, MD & phD', 'investigatorAffiliation': 'Xijing Hospital'}}}}