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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01758861

Enrollment

Registered

2013-01-01

Start date

2011-07-31

Completion date

2012-10-31

Last updated

2013-01-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury

Keywords

Erythropoietin, acute kidney injury, valvular heart surgery

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.

Interventions

DRUGEPO group

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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).

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 22, 2026