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

Thammasat University

Status and phase: Unknown; Phase 3

Conditions: Acute Renal Failure

Treatments: Drug: placebo; Drug: beta erythropoietin

Study type: Interventional

Funder types: Other

Identifiers

NCT01066351

MTU-E-1-57/52

Details and patient eligibility

About

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

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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200 participants in 2 patient groups, including a placebo group

Erythropoietin

Experimental group

Description:

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.

Treatment:

Drug: beta erythropoietin

placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: placebo