Efficacy of Erythropoietin to Prevent Acute Kidney Injury in Chronic Kidney Disease Patients Undergoing Cardiac Surgery

Acute Renal Failure Clinical Trial

Official title:

Efficacy of Erythropoietin to Prevent Acute Kidney Injury in Chronic Kidney Disease Patients Undergoing Cardiac Surgery

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01066351
• Other study ID #: MTU-E-1-57/52
• Status: Enrolling by invitation
• Phase: Phase 3
• First received: February 9, 2010
• Last updated: February 9, 2010
• Start date: January 2010
• Est. completion date: June 2011

Study information

• Verified date: January 2010
• Source: Thammasat University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: June 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

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

Intervention

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.
• placebo
The patients were assigned to receive normal saline same volume at 3 day before cardiac surgery and in the morning before cardiac surgery.

Locations

Country	Name	City	State
Thailand	Adis Tasanarong	Khlong Luang	Pathumtani

Sponsors (1)

Lead Sponsor	Collaborator
Thammasat University

Country where clinical trial is conducted

Thailand, 

References & Publications (3)

Bahlmann FH, Fliser D. Erythropoietin and renoprotection. Curr Opin Nephrol Hypertens. 2009 Jan;18(1):15-20. doi: 10.1097/MNH.0b013e32831a9dde. Review. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary end-point of this study is the development of AKI in placebo group compared with EPO group.		1.5 year	Yes
Secondary	The secondary end-point of this study is compare urine NGAL level in AKI patients between both groups		1.5 year	Yes

External Links

•   The Nephrology Society of Thailand
•   Toxicology data network