Effect of Erythropoietin (EPO) in Kidney After Cardiac Surgery

Phase 2

Completed

• Conditions: Kidney Failure, Acute
• Interventions: Drug: Erythropoietin-Beta; Drug: Normal Saline

• Registration Number: NCT00654992
• Lead Sponsor: Seoul National University Bundang Hospital

Brief Summary

The purpose of this study is to determine whether erythropoietin is effective in preventing acute kidney dysfunction after coronary artery bypass grafting surgery.

Detailed Description

Acute kidney injury (AKI) occurs in 7% to 40% of patients undergoing cardiac surgery, depending on the definition of AKI used. Even small increments in serum creatinine have been shown to be associated with increased mortality after cardiac surgery. However, there are no proven interventions to prevent AKI after cardiac surgery. Erythropoietin (EPO) has been shown to have tissue-protective effects in various experimental models. In this prospective placebo-controlled randomized trial, we evaluated the effectiveness of EPO in the prevention of AKI after coronary artery bypass grafting (CABG).

Study Timeline

• Study Start: 2006-09
• Primary Completion: 2008-02
• Study First Submitted: 2008-04-04
• Study First Submitted QC: 2008-04-04
• Study First Posted: 2008-04-09
• Study Completion: 2009-02
• Results First Submitted: 2009-03-17
• Status Verified: 2009-04
• Results First Submitted QC: 2009-04-28
• Last Update Submitted: 2009-04-28
• Results First Posted: 2009-06-16
• Last Update Posted: 2009-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

Inclusion Criteria

• Patients scheduled for elective CABG over age 18

Exclusion Criteria

• Under age 18
• Emergent CABG
• Prior exposure to nephrotoxic drug
• Dialysis patients
• Uncontrolled hypertension

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EPO group	Erythropoietin-Beta	-
Placebo group	Normal Saline	-

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Had AKI (Acute Kidney Injury)	at any time within the first 5 days after surgery	number of participants who had 50% increase in serum creatinine levels from baseline

Secondary Outcome Measures

Name	Time	Method
Change in Estimated Glomerular Filtration Rate (eGFR)	during the first 5 days after surgery	estimated glomerular filtration rate (eGFR)as ml/min/1.73m2

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of