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

T

Thammasat University

Status and phase

Unknown
Phase 3

Conditions

Acute Renal Failure

Treatments

Drug: placebo
Drug: beta erythropoietin

Study type

Interventional

Funder types

Other

Identifiers

NCT01066351
MTU-E-1-57/52

Details and patient eligibility

About

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

Full 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.

Enrollment

200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

200 participants in 2 patient groups, including a placebo group

Erythropoietin
Experimental group
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.
Treatment:
Drug: beta erythropoietin
placebo
Placebo Comparator group
Description:
The patients were assigned to receive normal saline same volume at 3 day before cardiac surgery and in the morning before cardiac surgery.
Treatment:
Drug: placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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