Overview

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

Status:
Completed
Trial end date:
2012-10-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Yonsei University
Treatments:
Anesthetics
Epoetin Alfa
Criteria
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.