- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01758861
Effect of Erythropoietin on the Incidence of Acute Kidney Injury Following Complex Valvular Heart Surgery
December 31, 2012 updated by: Yonsei University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
98
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Seoul, Korea, Republic of, 120-752
- Department of Anesthesiology and Pain Medicine Yonsei University College of Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: EPO group
EPO group received 300 IU/kg of rHuEPO-alpha via intravenous bolus administration after induction of anesthesia.
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Other Names:
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Placebo Comparator: Placebo group
Placebo group received normal saline via intravenous bolus administration after induction of anesthesia.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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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).
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change of renal function including SCr, cystatin C, creatinine clearance from 24 h before operation to postoperative day (POD) 5
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2011
Primary Completion (Actual)
September 1, 2012
Study Completion (Actual)
October 1, 2012
Study Registration Dates
First Submitted
December 17, 2012
First Submitted That Met QC Criteria
December 31, 2012
First Posted (Estimate)
January 1, 2013
Study Record Updates
Last Update Posted (Estimate)
January 1, 2013
Last Update Submitted That Met QC Criteria
December 31, 2012
Last Verified
December 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4-2011-0355
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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