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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
Results First Received: March 17, 2009  
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
Condition: Kidney Failure, Acute
Interventions: Drug: Erythropoietin-Beta
Drug: Normal Saline

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Erythropoietin (EPO) Group received 300 U/kg of erythropoietin intraveously following induction of anesthesia
Placebo Group received normal saline intraveously following induction of anesthesia

Participant Flow:   Overall Study
    Erythropoietin (EPO) Group     Placebo Group  
STARTED     36     35  
COMPLETED     36     35  
NOT COMPLETED     0     0  



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

2.  Secondary:   Change in Estimated Glomerular Filtration Rate (eGFR)   [ Time Frame: during the first 5 days after surgery ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:  
Name/Title: Effect of erythropoietin in kidney after cardiac surgery
Organization: Seoul National University Bundang Hospital
phone: 82-31-787-7014
e-mail: kyna@snubh.org


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