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

Study Overview
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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.

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.

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

Conditions
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Acute Renal Failure

Intervention / Treatment
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* Drug: beta erythropoietin
* Drug: placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 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: Erythropoietin<br>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. | Drug: beta erythropoietin<br>* 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.<br>* Other names: Recormon;|
| Placebo Comparator: placebo<br>The patients were assigned to receive normal saline same volume at 3 day before cardiac surgery and in the morning before cardiac surgery. | Drug: placebo<br>* The patients were assigned to receive normal saline same volume at 3 day before cardiac surgery and in the morning before cardiac surgery.<br>* Other names: normal saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary end-point of this study is the development of AKI in placebo group compared with EPO group. |  | 1.5 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary end-point of this study is compare urine NGAL level in AKI patients between both groups |  | 1.5 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute kidney injury, erythropoietin, cardiac surgery