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

• Sponsor: Yonsei University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01758861
• Collaborator: (none)
• Enrollment: 98
• Location: 1
• Arms: 2
• Duration (Months): 15
• Patients Per Site Per Month: 6.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Kidney Injury	Drug: EPO group; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 98 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Prevention
• Study Start Date: Jul 1, 2011
• Actual Primary Completion Date: Sep 1, 2012
• Actual Study Completion Date: Oct 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: EPO group EPO group received 300 IU/kg of rHuEPO-alpha via intravenous bolus administration after induction of anesthesia.	Drug: EPO group; Other Names: 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

Outcome Measures

Primary Outcome Measures

1. incidence of acute kidney injury [change of renal function including SCr, cystatin C, creatinine clearance from 24 h before operation to postoperative day (POD) 5]

   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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: 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:

• 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

Locations

	Site	City	State	Country	Postal Code
1	Department of anesthesiology and pain medicine Yonsei University College of Medicine	Seoul		Korea, Republic of	120-752

Sponsors and Collaborators

• Yonsei University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yonsei University
• ClinicalTrials.gov Identifier: NCT01758861
• Other Study ID Numbers: 4-2011-0355
• First Posted: Jan 1, 2013
• Last Update Posted: Jan 1, 2013
• Last Verified: Dec 1, 2012

• Keywords provided by Yonsei University: Erythropoietin; acute kidney injury; valvular heart surgery
• Additional relevant MeSH terms: Acute Kidney Injury

Study Results

No Results Posted as of Jan 1, 2013