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

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ClinicalTrials.gov Identifier: NCT00654992
Recruitment Status : Completed
First Posted : April 9, 2008
Results First Posted : June 16, 2009
Last Update Posted : June 16, 2009
Sponsor:
Information provided by:

Study Description
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.

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

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : September 2006
Primary Completion Date : February 2008
Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Number of Participants Who Had AKI (Acute Kidney Injury) [ Time Frame: at any time within the first 5 days after surgery ]

Secondary Outcome Measures :
  1. Change in Estimated Glomerular Filtration Rate (eGFR) [ Time Frame: during the first 5 days after surgery ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: April 9, 2008    Key Record Dates
Results First Posted: June 16, 2009
Last Update Posted: June 16, 2009
Last Verified: April 2009

Additional relevant MeSH terms:
Renal Insufficiency
Acute Kidney Injury
Kidney Diseases
Urologic Diseases
Epoetin Alfa
Hematinics