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

Primary Purpose

Acute Renal Failure

Status
Unknown status
Phase
Phase 3
Locations
Thailand
Study Type
Interventional
Intervention
beta erythropoietin
placebo
Sponsored by
Thammasat University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Renal Failure focused on measuring acute kidney injury, erythropoietin, cardiac surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Adis Tasanarong

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Erythropoietin

placebo

Arm Description

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.

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

Outcomes

Primary Outcome Measures

The primary end-point of this study is the development of AKI in placebo group compared with EPO group.

Secondary Outcome Measures

The secondary end-point of this study is compare urine NGAL level in AKI patients between both groups

Full Information

First Posted
February 9, 2010
Last Updated
February 9, 2010
Sponsor
Thammasat University
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1. Study Identification

Unique Protocol Identification Number
NCT01066351
Brief Title
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

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Unknown status
Study Start Date
January 2010 (undefined)
Primary Completion Date
March 2011 (Anticipated)
Study Completion Date
June 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Thammasat University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Renal Failure
Keywords
acute kidney injury, erythropoietin, cardiac surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Erythropoietin
Arm Type
Experimental
Arm Description
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.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
The patients were assigned to receive normal saline same volume at 3 day before cardiac surgery and in the morning before cardiac surgery.
Intervention Type
Drug
Intervention Name(s)
beta erythropoietin
Other Intervention Name(s)
Recormon
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
placebo
Other Intervention Name(s)
normal saline
Intervention Description
The patients were assigned to receive normal saline same volume at 3 day before cardiac surgery and in the morning before cardiac surgery.
Primary Outcome Measure Information:
Title
The primary end-point of this study is the development of AKI in placebo group compared with EPO group.
Time Frame
1.5 year
Secondary Outcome Measure Information:
Title
The secondary end-point of this study is compare urine NGAL level in AKI patients between both groups
Time Frame
1.5 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adis Tasanarong, MD
Organizational Affiliation
Thammasat Universuty
Official's Role
Principal Investigator
Facility Information:
Facility Name
Adis Tasanarong
City
Khlong Luang
State/Province
Pathumtani
ZIP/Postal Code
12121
Country
Thailand

12. IPD Sharing Statement

Citations:
PubMed Identifier
19494484
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.
Results Reference
background
PubMed Identifier
19077684
Citation
Bahlmann FH, Fliser D. Erythropoietin and renoprotection. Curr Opin Nephrol Hypertens. 2009 Jan;18(1):15-20. doi: 10.1097/MNH.0b013e32831a9dde.
Results Reference
background
PubMed Identifier
19005302
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.
Results Reference
background
PubMed Identifier
23829828
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.
Results Reference
derived
Links:
URL
http://www.nephrothai.org/
Description
The Nephrology Society of Thailand

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

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