Effect of Erythropoietin (EPO) in Kidney After Cardiac Surgery

Kidney Failure, Acute Clinical Trial

— EPO-CABG  

Official title:

Prevention of Acute Kidney Injury (AKI) by Erythropoietin (EPO) in Patients Undergoing Coronary Artery Bypass Grafting (CABG) Surgery - A Prospective Placebo-Controlled Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00654992
• Other study ID #: SNUBH B-0608/036-004
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: April 4, 2008
• Last updated: April 28, 2009
• Start date: September 2006
• Est. completion date: February 2009

Study information

• Verified date: April 2009
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: February 2009
• Est. primary completion date: February 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acute Kidney Injury
• Kidney Failure, Acute
• Renal Insufficiency

Intervention

Drug:
• Erythropoietin-Beta
300 IU/kg of EPO or saline intravenously before surgery
• Normal Saline
300 IU/kg of normal saline intravenously before surgery

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Had AKI (Acute Kidney Injury)		at any time within the first 5 days after surgery	Yes
Secondary	Change in Estimated Glomerular Filtration Rate (eGFR)		during the first 5 days after surgery	Yes