Skip to main content
OpenTrials
Completed

NCT Number: NCT00654992

Effect of Erythropoietin (EPO) in Kidney After Cardiac Surgery

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Kidney Failure, Acute Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Erythropoietin-Beta

Drug

300 IU/kg of EPO or saline intravenously before surgery

Other names: recormon

normal saline

Drug

300 IU/kg of normal saline intravenously before surgery

Other names: 0.9% saline

Primary outcomes

  1. Number of Participants Who Had AKI (Acute Kidney Injury)

    Time frame: at any time within the first 5 days after surgery

    number of participants who had 50% increase in serum creatinine levels from baseline

Secondary outcomes

  1. Change in Estimated Glomerular Filtration Rate (eGFR)

    Time frame: during the first 5 days after surgery

    estimated glomerular filtration rate (eGFR)as ml/min/1.73m2

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Official study 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

Acronym: EPO-CABG

Important dates

Study start
2006
Primary completion
2008
Study completion
2009
First posted
Apr 9, 2008
Registry last updated
Jun 16, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.