Efficacy of Erythropoietin to Prevent Acute Kidney Injury in Chronic Kidney Disease Patients Undergoing Cardiac 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

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2011-06-30

Brief Summary

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The purpose of this study is to demonstrate the efficacy of erythropoietin for prevention acute kidney injury in CKD patients undergoing cardiac surgery.

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Detailed Description

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Acute kidney injury (AKI)occur 7.7-42% after cardiac surgery. The incidence of AKI requiring renal replacement therapy following coronary artery bypass grafting (CABG) surgery was 0.7-3.5% and increase mortality rate. Erythropoietin (EPO) is now considered a novel anti-apoptotic and anti-inflammatory action. The present study was designed to evaluate the administration of EPO as a means of preventing AKI in these patients.

Conditions

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Acute Renal Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Erythropoietin

The patients were assigned to receive beta erythropoietin (Recormon) dose 200 unit/kg at 3 day before cardiac surgery and 100 unit/kg in the morning before cardiac surgery.

Group Type EXPERIMENTAL

beta erythropoietin

Intervention Type DRUG

The patients were assigned to receive beta erythropoietin (Recormon) dose 200 unit/kg at 3 day before cardiac surgery and 100 unit/kg in the morning before cardiac surgery.

placebo

The patients were assigned to receive normal saline same volume at 3 day before cardiac surgery and in the morning before cardiac surgery.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

The patients were assigned to receive normal saline same volume at 3 day before cardiac surgery and in the morning before cardiac surgery.

Interventions

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beta erythropoietin

The patients were assigned to receive beta erythropoietin (Recormon) dose 200 unit/kg at 3 day before cardiac surgery and 100 unit/kg in the morning before cardiac surgery.

Intervention Type DRUG

placebo

The patients were assigned to receive normal saline same volume at 3 day before cardiac surgery and in the morning before cardiac surgery.

Intervention Type DRUG

Other Intervention Names

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Recormon normal saline

Eligibility Criteria

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Inclusion Criteria

* age \> 18 years.
* serum creatinine levels \> 1.2 mg/dL and baseline creatinine clearance levels \< 60 mL/min (as measured in their most recent sample,drawn within 2 months prior to the beginning of the study)
* patients who need cardiac surgery

Exclusion Criteria

* patients with acute kidney injury
* end stage renal disease (requiring dialysis)
* unstable renal function (as evidenced by a change in serum creatinine of \> 0.5 mg/dL, or \> 25%, within 14 days prior to the study)
* allergy to any of erythropoietin
* suffered from congestive heart failure, cardiogenic shock or emergent cardiac surgery.
* receiving erythropoietin within 14 days before the study

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No