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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2012-10-31

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.

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Detailed Description

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Conditions

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Acute Kidney Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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EPO group

EPO group received 300 IU/kg of rHuEPO-alpha via intravenous bolus administration after induction of anesthesia.

Group Type EXPERIMENTAL

EPO group

Intervention Type DRUG

Placebo group

Placebo group received normal saline via intravenous bolus administration after induction of anesthesia.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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EPO group

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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EPO group received 300 IU/kg of rHuEPO-alpha via intravenous bolus administration after induction of anesthesia.

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.

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No