Ignite Creation Date:
2025-12-24 @ 4:51 PM
Ignite Modification Date:
2025-12-27 @ 1:23 PM
Study NCT ID:
NCT01560650
Status:
COMPLETED
Last Update Posted:
2016-01-20
First Post:
2012-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of the Intensity of Continuous Renal Replacement Therapy in Patients With Acute Kidney Injury
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': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 211}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-17', 'studyFirstSubmitDate': '2012-03-20', 'studyFirstSubmitQcDate': '2012-03-21', 'lastUpdatePostDateStruct': {'date': '2016-01-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'death from any cause', 'timeFrame': '14, 28 ,90 and 365 days after randomization', 'description': 'The primary study outcome was death from any cause within 14, 28 ,90 and 365 days after randomization.'}], 'secondaryOutcomes': [{'measure': 'renal outcome of survivors', 'timeFrame': '14, 28 ,90 and 365 days after randomization', 'description': 'Secondary outcomes were renal outcome of survivors14, 28 ,90 and 365 days after randomization'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['CRRT', 'cardiac surgery associated acute kidney injury', 'Intensity'], 'conditions': ['Acute Kidney Injury']}, 'referencesModule': {'references': [{'pmid': '36416787', 'type': 'DERIVED', 'citation': 'Fayad AI, Buamscha DG, Ciapponi A. Timing of kidney replacement therapy initiation for acute kidney injury. Cochrane Database Syst Rev. 2022 Nov 23;11(11):CD010612. doi: 10.1002/14651858.CD010612.pub3.'}]}, 'descriptionModule': {'briefSummary': 'The current international Continuous Renal Replacement Therapy (CRRT) replacement fluid doses of 35 ml/kg/h is better, but the result is according to white people, black people . It is Whether the best amount of replacement fluid for Chinese people, it is unclear. Especially,there is little evidence about the optimal dose from randomized trials in Cardiac surgery associated acute kidney injury (CSA-AKI )required CRRT,According to the clinical situation, the design of replacement fluid to 25 ml/kg/h.The observation of two doses 14 days, 28 days, 90 days survival and renal function.', 'detailedDescription': 'Acute kidney injury (AKI) is a major complication in patients with cardiac surgery and is an independent predictor of mortality. However, the optimal intensity of renal replacement therapy for such patients is still controversial. we randomly assigned the patients with Cardiac surgery-associated acute kidney injury (CSA-AKI) to continuous renal replacement therapy with different treatment dose (35ml / kg / h or 25ml/kg／h),The primary study outcome was death from any cause within 14, 28 and 90 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\> = 18 years of age, CRRT indications for acute kidney injury (RIFLE criteria) patients with cardiac surgery\n\nExclusion Criteria:\n\n* \\< 18 years old,\n* with chronic kidney disease,\n* dialysis history, to leave the ICU patients with acute kidney injury (AKI). - chronic kidney disease,\n* all causes kidney damage (pathology, hematuria, and radiographic abnormalities)\\> = 3 months or glomerular filtration rate \\< 60ml/min for 3 months or more.'}, 'identificationModule': {'nctId': 'NCT01560650', 'briefTitle': 'Effect of the Intensity of Continuous Renal Replacement Therapy in Patients With Acute Kidney Injury', 'organization': {'class': 'OTHER', 'fullName': "Guangdong Provincial People's Hospital"}, 'officialTitle': 'Effect of the Intensity of Continuous Renal Replacement Therapy in Patients With Cardiac Surgery Associated Acute Kidney Injury (CRITERIA STUDY)', 'orgStudyIdInfo': {'id': 'LXL-CRRT2535'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'high dose (35ml/kg/h)', 'description': '\\> = 18 years of age, CRRT indications for acute kidney injury (RIFLE criteria) patients with cardiac surgery, was given filtration at a rate of 35 mL/kg/h.', 'interventionNames': ['Device: CRRT']}, {'type': 'EXPERIMENTAL', 'label': 'low dose (25ml/kg/h)', 'description': '\\> = 18 years of age, CRRT indications for acute kidney injury (RIFLE criteria) patients with cardiac surgery, was given filtration at a rate of 25 mL/kg/h.', 'interventionNames': ['Device: CRRT']}], 'interventions': [{'name': 'CRRT', 'type': 'DEVICE', 'description': 'Difference dose of CRRT', 'armGroupLabels': ['high dose (35ml/kg/h)', 'low dose (25ml/kg/h)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Nephrology Department,Guangdong General Hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'Wei Shi, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Guangdong Provincial People's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wei Shi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director of renal division of Guangdong General Hospital', 'investigatorFullName': 'Wei Shi', 'investigatorAffiliation': "Guangdong Provincial People's Hospital"}}}}