Clinical trial NCT01066351: Efficacy of Erythropoietin to Prevent Acute Kidney Injury in Chronic Kidney Disease Patients Undergoing Cardiac Surgery
Official title: Efficacy of Erythropoietin to Prevent Acute Kidney Injury in Chronic Kidney Disease Patients Undergoing Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Acute Renal Failure
Keywords: acute kidney injury
erythropoietin
cardiac surgery
Lead sponsor: Thammasat University
Sponsor class: OTHER
First posted: 2010-02-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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 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

Primary outcomes:
measure: The primary end-point of this study is the development of AKI in placebo group compared with EPO group.
timeFrame: 1.5 year
Secondary outcomes:
measure: The secondary end-point of this study is compare urine NGAL level in AKI patients between both groups
timeFrame: 1.5 year
Other outcomes:
Locations:
city: Khlong Luang
country: Thailand
facility: Adis Tasanarong
state: Pathumtani
Study officials:
affiliation: Thammasat Universuty
name: Adis Tasanarong, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1159/000223229. Epub 2009 Jun 2.
citation: Bahlmann FH, Fliser D. Erythropoietin and renoprotection. Curr Opin Nephrol Hypertens. 2009 Jan;18(1):15-20. doi: 10.1097/MNH.0b013e32831a9dde.
citation: 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. doi: 10.1097/MCC.0b013e328317ee82.
citation: Tasanarong A, Duangchana S, Sumransurp S, Homvises B, Satdhabudha O. Prophylaxis with erythropoietin versus placebo reduces acute kidney injury and neutrophil gelatinase-associated lipocalin in patients undergoing cardiac surgery: a randomized, double-blind controlled trial. BMC Nephrol. 2013 Jul 5;14:136. doi: 10.1186/1471-2369-14-136.