Effect of Erythropoietin in Kidney After Cardiac Surgery - Full Text View

Sponsored by:	Seoul National University Bundang Hospital
Information provided by:	Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:	NCT00654992

Purpose

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

Condition	Intervention	Phase
Kidney Failure, Acute	Drug: Erythropoietin-Beta Drug: Normal Saline	Phase II Phase III

MedlinePlus related topics: Coronary Artery Bypass Surgery Kidney Failure

Drug Information available for: Epoetin alfa Erythropoietin Epoetin beta

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Prevention of Acute Kidney Injury (AKI) by Erythropoietin in Patients Undergoing Coronary Artery Bypass Grafting (CABG) Surgery - A Prospective Placebo-Controlled Randomized Trial

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

Primary Outcome Measures:

The incidence of AKI, defined as a 50% or greater increase in serum creatinine from baseline. [ Time Frame: within the first 5 days after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

the relative change in serum creatinine, GFR and urine NGAL from baseline [ Time Frame: within the first 5 days after surgery ] [ Designated as safety issue: No ]

Estimated Enrollment:	132
Study Start Date:	September 2006
Estimated Study Completion Date:	July 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
EPO group: Active Comparator	Drug: Erythropoietin-Beta 300 IU/kg of EPO or saline intravenously before surgery
Placebo group: Placebo Comparator	Drug: Normal Saline 300 IU/kg of normal saline intravenously before 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).

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

Contacts

Contact: Ki Young ,Na, MD PhD

82-31-787-7014

kyna@snubh.org

Locations

Korea, Republic of, Gyeonggi-do
Seoul National University Bundang Hospital	Recruiting
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
Principal Investigator: Ki Young ,Na, MD PhD

Sponsors and Collaborators

Seoul National University Bundang Hospital

Investigators

Principal Investigator:

Ki Young , Na, MD PhD

Department of Internal Medicine

More Information

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

Study placed in the following topic categories:

Epoetin Alfa
Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Acute

Kidney Diseases
Kidney Failure, Acute
Kidney Failure

Additional relevant MeSH terms:

Hematinics
Therapeutic Uses
Hematologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009