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

Phase 3

• Conditions: Acute Renal Failure
• Interventions: Drug: placebo; Drug: beta erythropoietin

• Registration Number: NCT01066351
• Lead Sponsor: Thammasat University

Brief Summary

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

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.

Study Timeline

• Status Verified: 2010-01
• Study Start: 2010-01
• Study First Submitted: 2010-02-09
• Study First Submitted QC: 2010-02-09
• Last Update Submitted: 2010-02-09
• Study First Posted: 2010-02-10
• Last Update Posted: 2010-02-10
• Primary Completion: 2011-03
• Study Completion: 2011-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
The secondary end-point of this study is compare urine NGAL level in AKI patients between both groups	1.5 year

Trial Locations

Locations (1)

Adis Tasanarong; 🇹🇭 Khlong Luang, Pathumtani, Thailand