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CompletedNCT01758861Updated Jan 1, 2013

Effect of Erythropoietin on the Incidence of Acute Kidney Injury Following Complex Valvular Heart Surgery

A Phase 2 interventional study of EPO group and Placebo in Acute Kidney Injury, sponsored by Yonsei University. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2013-01-01.

Sponsored by Yonsei University · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
98
Allocation
Randomized
Ages
20 Years and older
Sex
All
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Study summary

Acute kidney injury (AKI) frequently occurs after cardiac surgery using cardiopulmonary bypass (CPB). Recombinant human erythropoietin (rHuEPO) is known to provide organ protection against ischemia-reperfusion injury through its anti-inflammatory properties. The aim of the present study was to investigate the effect of a single preoperative bolus of EPO on the incidence of AKI following complex valvular heart surgery in a randomized, controlled and double-blind trial.

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Conditions studied

  • Acute Kidney Injury

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Keywords

  • Erythropoietin
  • acute kidney injury
  • valvular heart surgery
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In context

Acute Kidney Injury

1,595 studies on the registry are indexed under Acute Kidney Injury; 371 are open to participants now.

This study's enrollment of 98 is close to the median of 100 across 763 interventional studies indexed under Acute Kidney Injury.

Browse Acute Kidney Injury studies →

Lead sponsor

Yonsei University is the lead sponsor of 1,387 studies on the registry; 232 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • preoperative risk factors for AKI and scheduled for complex valvular heart operations
  • Enrolled criteria for high risk of AKI were patients with more than 2 of bellows: female, serum creatinine >1.2 mg/dl, preoperative A-fib, GFR \< 60 ml/min, NYHA class IV, HTN, DM, age > 65 years, peripheral vascular disease.
  • Complex valvular heart operations were defined as double-valve surgery, combined valve and coronary artery bypass grafting procedures, Bentall operation, combined mitral valve surgery and tricuspid annuloplasty or reoperation.

Exclusion criteria

Exclusion Criteria:

  • Patients with preexisting uncontrolled hypertension (diastolic blood pressure > 100 mmHg), immunosuppression, history of thromboembolism, malignant disease, seizure, liver dysfunction, renal impairment (serum creatinine > 2 mg/dL), and drug or alcohol abuse were excluded.
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Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
98 participants (actual)

Study arms

  • Experimental
    EPO group

    EPO group received 300 IU/kg of rHuEPO-alpha via intravenous bolus administration after induction of anesthesia.

    Drug: EPO group

  • Placebo comparator
    Placebo group

    Placebo group received normal saline via intravenous bolus administration after induction of anesthesia.

    Drug: Placebo

Interventions

  • DrugEPO group

    Also known as: EPO group received 300 IU/kg of rHuEPO-alpha via intravenous bolus administration after induction of anesthesia.

  • DrugPlacebo
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What researchers measure

Primary outcomes

  1. incidence of acute kidney injury

    The diagnostic criteria for AKI is followed by AKIN criteria (absolutely increase in the SCr concentration ≥ 0.3 mg/dL from baseline, ≥ 50% increase in the SCr concentration within 48 hours after operation).

    Time frame: change of renal function including SCr, cystatin C, creatinine clearance from 24 h before operation to postoperative day (POD) 5

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Study locations

1 site
  • Department of anesthesiology and pain medicine Yonsei University College of Medicine
    Seoul, 120-752, Korea, Republic of
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References and documents

Publications

  • Kim JH, Shim JK, Song JW, Song Y, Kim HB, Kwak YL. Effect of erythropoietin on the incidence of acute kidney injury following complex valvular heart surgery: a double blind, randomized clinical trial of efficacy and safety. Crit Care. 2013 Oct 24;17(5):R254. doi: 10.1186/cc13081. PubMed 24156702 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 1, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01758861
Lead sponsor
Yonsei University
Responsible party
Sponsor
First posted
Jan 1, 2013
Start date
Jul 2011
Primary completion
Sep 2012
Completion
Oct 2012
Last update
Jan 1, 2013

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2012. You cannot join it, but the record below documents what was studied.

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