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Effect of Erythropoietin (EPO) in Kidney After Cardiac Surgery (EPO-CABG)

This study has been completed.
Sponsor:
Information provided by:
Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:
NCT00654992
First received: April 4, 2008
Last updated: April 28, 2009
Last verified: April 2009
History of Changes
  Purpose

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


Condition Intervention Phase
Kidney Failure, Acute
 Drug: Erythropoietin-Beta
Drug: Normal Saline
 Phase 2
Phase 3

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Seoul National University Bundang Hospital:

Primary Outcome Measures:
  • Number of Participants Who Had AKI (Acute Kidney Injury) [ Time Frame: at any time within the first 5 days after surgery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change in Estimated Glomerular Filtration Rate (eGFR) [ Time Frame: during the first 5 days after surgery ] [ Designated as safety issue: Yes ]

Enrollment: 71
Study Start Date: September 2006
Study Completion Date: February 2009
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: EPO group Drug: Erythropoietin-Beta
300 IU/kg of EPO or saline intravenously before surgery
Other Name: recormon
Placebo Comparator: Placebo group Drug: Normal Saline
300 IU/kg of normal saline intravenously before surgery
Other Name: 0.9% saline

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00654992

Locations
Korea, Republic of
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
Sponsors and Collaborators
Seoul National University Bundang Hospital
Investigators
Principal Investigator: Ki Young , Na, MD PhD Department of Internal Medicine
  More Information

No publications provided

Responsible Party: Ki Young Na/MD PhD, Department of Internal Medicine
ClinicalTrials.gov Identifier: NCT00654992     History of Changes
Other Study ID Numbers: SNUBH B-0608/036-004
Study First Received: April 4, 2008
Results First Received: March 17, 2009
Last Updated: April 28, 2009
Health Authority: South Korea: Institutional Review Board

Additional relevant MeSH terms:
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Epoetin Alfa
 Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013