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

NCT01758861 | Completed Phase 2

• 1 other identifier: 4-2011-0355
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Kidney Injury

Keywords

Erythropoietin; acute kidney injury; valvular heart surgery

Outcome Measures

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).

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

Study Arms (2)

EPO group

EXPERIMENTAL

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

Drug: EPO group

Placebo group

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

EPO group DRUG

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

EPO group

Placebo DRUG

Placebo group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Department of anesthesiology and pain medicine Yonsei University College of Medicine

Seoul, Seoul, 120-752, South Korea

Location

Related Publications (1)

• 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.

  PMID: 24156702 DERIVED

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2012
• First Posted: January 1, 2013
• Study Start: July 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: October 1, 2012
• Last Updated: January 1, 2013

Record last verified: 2012-12

Locations

KR (1)