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

Study Overview
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Brief Summary
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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.

Conditions
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Acute Kidney Injury

Intervention / Treatment
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* Drug: EPO group
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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. 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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EPO group<br>EPO group received 300 IU/kg of rHuEPO-alpha via intravenous bolus administration after induction of anesthesia. | Drug: EPO group<br> <br> * Other names: EPO group received 300 IU/kg of rHuEPO-alpha via intravenous bolus administration after induction of anesthesia.;|
| Placebo Comparator: Placebo group<br>Placebo group received normal saline via intravenous bolus administration after induction of anesthesia. | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of acute kidney injury | 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). | change of renal function including SCr, cystatin C, creatinine clearance from 24 h before operation to postoperative day (POD) 5 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Erythropoietin, acute kidney injury, valvular heart surgery