Efficacy of Erythropoietin to Prevent Acute Kidney Injury in Chronic Kidney Disease Patients Undergoing Cardiac Surgery - Full Text View

Purpose

The purpose of this study is to demonstrate the efficacy of erythropoietin for prevention acute kidney injury in CKD patients undergoing cardiac surgery.

Condition	Intervention	Phase
Acute Renal Failure	Drug: beta erythropoietin Drug: placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	Efficacy of Erythropoietin to Prevent Acute Kidney Injury in Chronic Kidney Disease Patients Undergoing Cardiac Surgery

Resource links provided by NLM:

MedlinePlus related topics: Chronic Kidney Disease Heart Surgery

Drug Information available for: Erythropoietin Epoetin Alfa

U.S. FDA Resources

Further study details as provided by Thammasat University:

Primary Outcome Measures:

The primary end-point of this study is the development of AKI in placebo group compared with EPO group. [ Time Frame: 1.5 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

The secondary end-point of this study is compare urine NGAL level in AKI patients between both groups [ Time Frame: 1.5 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	200
Study Start Date:	January 2010
Estimated Study Completion Date:	June 2011
Estimated Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Erythropoietin The patients were assigned to receive beta erythropoietin (Recormon) dose 200 unit/kg at 3 day before cardiac surgery and 100 unit/kg in the morning before cardiac surgery.	Drug: beta erythropoietin The patients were assigned to receive beta erythropoietin (Recormon) dose 200 unit/kg at 3 day before cardiac surgery and 100 unit/kg in the morning before cardiac surgery. Other Name: Recormon
Placebo Comparator: placebo The patients were assigned to receive normal saline same volume at 3 day before cardiac surgery and in the morning before cardiac surgery.	Drug: placebo The patients were assigned to receive normal saline same volume at 3 day before cardiac surgery and in the morning before cardiac surgery. Other Name: normal saline

Detailed Description:

Acute kidney injury (AKI)occur 7.7-42% after cardiac surgery. The incidence of AKI requiring renal replacement therapy following coronary artery bypass grafting (CABG) surgery was 0.7-3.5% and increase mortality rate. Erythropoietin (EPO) is now considered a novel anti-apoptotic and anti-inflammatory action. The present study was designed to evaluate the administration of EPO as a means of preventing AKI in these patients.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

age > 18 years.
serum creatinine levels > 1.2 mg/dL and baseline creatinine clearance levels < 60 mL/min (as measured in their most recent sample,drawn within 2 months prior to the beginning of the study)
patients who need cardiac surgery

Exclusion Criteria:

patients with acute kidney injury
end stage renal disease (requiring dialysis)
unstable renal function (as evidenced by a change in serum creatinine of > 0.5 mg/dL, or > 25%, within 14 days prior to the study)
allergy to any of erythropoietin
suffered from congestive heart failure, cardiogenic shock or emergent cardiac surgery.
receiving erythropoietin within 14 days before the study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01066351

Locations

Thailand
Adis Tasanarong
Khlong Luang, Pathumtani, Thailand, 12121

Sponsors and Collaborators

Thammasat University

Investigators

Principal Investigator:

Adis Tasanarong, MD

Thammasat Universuty

More Information

Additional Information:

The Nephrology Society of Thailand This link exits the ClinicalTrials.gov site

Toxicology data network This link exits the ClinicalTrials.gov site

Publications:

Song YR, Lee T, You SJ, Chin HJ, Chae DW, Lim C, Park KH, Han S, Kim JH, Na KY. Prevention of acute kidney injury by erythropoietin in patients undergoing coronary artery bypass grafting: a pilot study. Am J Nephrol. 2009;30(3):253-60. Epub 2009 Jun 2.

Bahlmann FH, Fliser D. Erythropoietin and renoprotection. Curr Opin Nephrol Hypertens. 2009 Jan;18(1):15-20. Review.

Bernhardt WM, Eckardt KU. Physiological basis for the use of erythropoietin in critically ill patients at risk for acute kidney injury. Curr Opin Crit Care. 2008 Dec;14(6):621-6. Review.

Responsible Party:	Adis Tasanarong, Faculty of Medicine, Thammasat University (Rangsit Campus)
ClinicalTrials.gov Identifier:	NCT01066351 History of Changes
Other Study ID Numbers:	MTU-E-1-57/52
Study First Received:	February 9, 2010
Last Updated:	February 9, 2010
Health Authority:	Thailand: Ethical Committee

Keywords provided by Thammasat University:

acute kidney injury
erythropoietin
cardiac surgery

Additional relevant MeSH terms:

Kidney Diseases
Acute Kidney Injury
Renal Insufficiency
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases

Epoetin Alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013