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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01066351

Enrollment

200

Registered

2010-02-10

Start date

2010-01-31

Completion date

2011-06-30

Last updated

2010-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Renal Failure

Keywords

acute kidney injury, erythropoietin, cardiac surgery

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.

Interventions

DRUGbeta 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.

DRUGplacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	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

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

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 23, 2026