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

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ClinicalTrials.gov Identifier: NCT01066351
Recruitment Status : Unknown
Verified January 2010 by Thammasat University.
Recruitment status was:  Enrolling by invitation
First Posted : February 10, 2010
Last Update Posted : February 10, 2010
Sponsor:
Information provided by:
Thammasat University

February 9, 2010
February 10, 2010
February 10, 2010
January 2010
March 2011   (Final data collection date for primary outcome measure)
The primary end-point of this study is the development of AKI in placebo group compared with EPO group. [ Time Frame: 1.5 year ]
Same as current
No Changes Posted
The secondary end-point of this study is compare urine NGAL level in AKI patients between both groups [ Time Frame: 1.5 year ]
Same as current
Not Provided
Not Provided
 
Efficacy of Erythropoietin to Prevent Acute Kidney Injury in Chronic Kidney Disease Patients Undergoing Cardiac Surgery
Efficacy of Erythropoietin to Prevent Acute Kidney Injury in Chronic Kidney Disease Patients Undergoing Cardiac Surgery
The purpose of this study is to demonstrate the efficacy of erythropoietin for prevention acute kidney injury in CKD patients undergoing cardiac surgery.
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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Acute Renal Failure
  • 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
  • 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
  • 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.
    Intervention: Drug: beta erythropoietin
  • 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.
    Intervention: Drug: placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
200
Same as current
June 2011
March 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Thailand
 
 
NCT01066351
MTU-E-1-57/52
Yes
Not Provided
Not Provided
Adis Tasanarong, Faculty of Medicine, Thammasat University (Rangsit Campus)
Thammasat University
Not Provided
Principal Investigator: Adis Tasanarong, MD Thammasat Universuty
Thammasat University
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP