Effect of Erythropoietin on the Incidence of Acute Kidney Injury Following Complex Valvular Heart Surgery

Phase 2

Completed

• Conditions: Acute Kidney Injury
• Interventions: Drug: Placebo; Drug: EPO group

• Registration Number: NCT01758861
• Lead Sponsor: Yonsei University

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-07
• Primary Completion: 2012-09
• Study Completion: 2012-10
• Status Verified: 2012-12
• Study First Submitted: 2012-12-17
• Study First Submitted QC: 2012-12-31
• Last Update Submitted: 2012-12-31
• Study First Posted: 2013-01-01
• Last Update Posted: 2013-01-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

Inclusion Criteria

• preoperative risk factors for AKI and scheduled for complex valvular heart operations
• 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.
• 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.

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Exclusion Criteria

• 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	Placebo	Placebo group received normal saline via intravenous bolus administration after induction of anesthesia.
EPO group	EPO group	EPO group received 300 IU/kg of rHuEPO-alpha via intravenous bolus administration after induction of anesthesia.

Primary Outcome Measures

Name	Time	Method
incidence of acute kidney injury	change of renal function including SCr, cystatin C, creatinine clearance from 24 h before operation to postoperative day (POD) 5	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).

Trial Locations

Locations (1)

Department of anesthesiology and pain medicine Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of