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

Primary Purpose

Kidney Failure, Acute

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Erythropoietin-Beta
Normal Saline
Sponsored by
Seoul National University Bundang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Kidney Failure, Acute

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Seoul National University Bundang Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

EPO group

Placebo group

Arm Description

Outcomes

Primary Outcome Measures

Number of Participants Who Had AKI (Acute Kidney Injury)
number of participants who had 50% increase in serum creatinine levels from baseline

Secondary Outcome Measures

Change in Estimated Glomerular Filtration Rate (eGFR)
estimated glomerular filtration rate (eGFR)as ml/min/1.73m2

Full Information

First Posted
April 4, 2008
Last Updated
April 28, 2009
Sponsor
Seoul National University Bundang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00654992
Brief Title
Effect of Erythropoietin (EPO) in Kidney After Cardiac Surgery
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Seoul National University Bundang Hospital

4. Oversight

Data Monitoring Committee
No

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Failure, Acute

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
71 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EPO group
Arm Type
Active Comparator
Arm Title
Placebo group
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Erythropoietin-Beta
Other Intervention Name(s)
recormon
Intervention Description
300 IU/kg of EPO or saline intravenously before surgery
Intervention Type
Drug
Intervention Name(s)
Normal Saline
Other Intervention Name(s)
0.9% saline
Intervention Description
300 IU/kg of normal saline intravenously before surgery
Primary Outcome Measure Information:
Title
Number of Participants Who Had AKI (Acute Kidney Injury)
Description
number of participants who had 50% increase in serum creatinine levels from baseline
Time Frame
at any time within the first 5 days after surgery
Secondary Outcome Measure Information:
Title
Change in Estimated Glomerular Filtration Rate (eGFR)
Description
estimated glomerular filtration rate (eGFR)as ml/min/1.73m2
Time Frame
during the first 5 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ki Young, Na, MD PhD
Organizational Affiliation
Department of Internal Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of

12. IPD Sharing Statement

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Effect of Erythropoietin (EPO) in Kidney After Cardiac Surgery

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