Ignite Creation Date:
2025-12-24 @ 12:21 PM
Ignite Modification Date:
2026-01-01 @ 6:50 AM
Study NCT ID:
NCT01758861
Status:
COMPLETED
Last Update Posted:
2013-01-01
First Post:
2012-12-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Erythropoietin on the Incidence of Acute Kidney Injury Following Complex Valvular Heart 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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 98}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-31', 'studyFirstSubmitDate': '2012-12-17', 'studyFirstSubmitQcDate': '2012-12-31', 'lastUpdatePostDateStruct': {'date': '2013-01-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'incidence of acute kidney injury', 'timeFrame': 'change of renal function including SCr, cystatin C, creatinine clearance from 24 h before operation to postoperative day (POD) 5', 'description': 'The diagnostic criteria for AKI is followed by AKIN criteria (absolutely increase in the SCr concentration ≥ 0.3 mg/dL from baseline, ≥ 50% increase in the SCr concentration within 48 hours after operation).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Erythropoietin', 'acute kidney injury', 'valvular heart surgery'], 'conditions': ['Acute Kidney Injury']}, 'referencesModule': {'references': [{'pmid': '24156702', 'type': 'DERIVED', 'citation': 'Kim JH, Shim JK, Song JW, Song Y, Kim HB, Kwak YL. Effect of erythropoietin on the incidence of acute kidney injury following complex valvular heart surgery: a double blind, randomized clinical trial of efficacy and safety. Crit Care. 2013 Oct 24;17(5):R254. doi: 10.1186/cc13081.'}]}, 'descriptionModule': {'briefSummary': 'Acute kidney injury (AKI) frequently occurs after cardiac surgery using cardiopulmonary bypass (CPB). Recombinant human erythropoietin (rHuEPO) is known to provide organ protection against ischemia-reperfusion injury through its anti-inflammatory properties. The aim of the present study was to investigate the effect of a single preoperative bolus of EPO on the incidence of AKI following complex valvular heart surgery in a randomized, controlled and double-blind trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* preoperative risk factors for AKI and scheduled for complex valvular heart operations\n* Enrolled criteria for high risk of AKI were patients with more than 2 of bellows: female, serum creatinine \\>1.2 mg/dl, preoperative A-fib, GFR \\< 60 ml/min, NYHA class IV, HTN, DM, age \\> 65 years, peripheral vascular disease.\n* Complex valvular heart operations were defined as double-valve surgery, combined valve and coronary artery bypass grafting procedures, Bentall operation, combined mitral valve surgery and tricuspid annuloplasty or reoperation.\n\nExclusion Criteria:\n\n* Patients with preexisting uncontrolled hypertension (diastolic blood pressure \\> 100 mmHg), immunosuppression, history of thromboembolism, malignant disease, seizure, liver dysfunction, renal impairment (serum creatinine \\> 2 mg/dL), and drug or alcohol abuse were excluded.'}, 'identificationModule': {'nctId': 'NCT01758861', 'briefTitle': 'Effect of Erythropoietin on the Incidence of Acute Kidney Injury Following Complex Valvular Heart Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'orgStudyIdInfo': {'id': '4-2011-0355'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EPO group', 'description': 'EPO group received 300 IU/kg of rHuEPO-alpha via intravenous bolus administration after induction of anesthesia.', 'interventionNames': ['Drug: EPO group']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'Placebo group received normal saline via intravenous bolus administration after induction of anesthesia.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'EPO group', 'type': 'DRUG', 'otherNames': ['EPO group received 300 IU/kg of rHuEPO-alpha via intravenous bolus administration after induction of anesthesia.'], 'armGroupLabels': ['EPO group']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '120-752', 'city': 'Seoul', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'Department of anesthesiology and pain medicine Yonsei University College of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}