Effect of Erythropoietin on the Incidence of Acute Kidney Injury Following Complex Valvular Heart Surgery
This study has been completed.
Sponsor:
Yonsei University
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01758861
First received: December 17, 2012
Last updated: December 31, 2012
Last verified: December 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Kidney Injury |
Drug: EPO group Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Prevention |
Resource links provided by NLM:
Further study details as provided by Yonsei University:
Primary Outcome Measures:
- incidence of acute kidney injury [ Time Frame: change of renal function including SCr, cystatin C, creatinine clearance from 24 h before operation to postoperative day (POD) 5 ] [ Designated as safety issue: No ]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).
| Enrollment: | 98 |
| Study Start Date: | July 2011 |
| Study Completion Date: | October 2012 |
| Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: EPO group
EPO group received 300 IU/kg of rHuEPO-alpha via intravenous bolus administration after induction of anesthesia.
|
Drug: EPO group
Other Name: EPO group received 300 IU/kg of rHuEPO-alpha via intravenous bolus administration after induction of anesthesia.
|
|
Placebo Comparator: Placebo group
Placebo group received normal saline via intravenous bolus administration after induction of anesthesia.
|
Drug: Placebo |
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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:
- 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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Yonsei University |
| ClinicalTrials.gov Identifier: | NCT01758861 History of Changes |
| Other Study ID Numbers: | 4-2011-0355 |
| Study First Received: | December 17, 2012 |
| Last Updated: | December 31, 2012 |
| Health Authority: | Korea: Institutional Review Board |
Keywords provided by Yonsei University:
|
Erythropoietin acute kidney injury valvular heart surgery |
Additional relevant MeSH terms:
|
Acute Kidney Injury Renal Insufficiency Kidney Diseases Urologic Diseases Anesthetics Epoetin Alfa Central Nervous System Depressants |
Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Hematinics Hematologic Agents |
ClinicalTrials.gov processed this record on May 19, 2013