Effect of Erythropoietin (EPO) in Kidney After Cardiac Surgery

NCT ID: NCT00654992

Last Updated: 2009-06-16

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2009-02-28

Brief Summary

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The purpose of this study is to determine whether erythropoietin is effective in preventing acute kidney dysfunction after coronary artery bypass grafting surgery.

Detailed Description

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Acute kidney injury (AKI) occurs in 7% to 40% of patients undergoing cardiac surgery, depending on the definition of AKI used. Even small increments in serum creatinine have been shown to be associated with increased mortality after cardiac surgery. However, there are no proven interventions to prevent AKI after cardiac surgery. Erythropoietin (EPO) has been shown to have tissue-protective effects in various experimental models. In this prospective placebo-controlled randomized trial, we evaluated the effectiveness of EPO in the prevention of AKI after coronary artery bypass grafting (CABG).

Conditions

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Kidney Failure, Acute

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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EPO group

Group Type ACTIVE_COMPARATOR

Erythropoietin-Beta

Intervention Type DRUG

300 IU/kg of EPO or saline intravenously before surgery

Placebo group

Group Type PLACEBO_COMPARATOR

Normal Saline

Intervention Type DRUG

300 IU/kg of normal saline intravenously before surgery

Interventions

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Erythropoietin-Beta

300 IU/kg of EPO or saline intravenously before surgery

Intervention Type DRUG

Normal Saline

300 IU/kg of normal saline intravenously before surgery

Intervention Type DRUG

Other Intervention Names

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recormon 0.9% saline

Eligibility Criteria

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Inclusion Criteria

* Patients scheduled for elective CABG over age 18

Exclusion Criteria

* Under age 18
* Emergent CABG
* Prior exposure to nephrotoxic drug
* Dialysis patients
* Uncontrolled hypertension
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Seoul National University Bundang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Department of Internal Medicine

Principal Investigators

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Ki Young, Na, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Internal Medicine

Locations

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Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

References

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Nishiwaki H, Abe Y, Suzuki T, Hasegawa T, Levack WM, Noma H, Ota E. Erythropoiesis-stimulating agents for preventing acute kidney injury. Cochrane Database Syst Rev. 2024 Sep 20;9(9):CD014820. doi: 10.1002/14651858.CD014820.pub2.

Reference Type DERIVED
PMID: 39301879 (View on PubMed)

Other Identifiers

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SNUBH B-0608/036-004

Identifier Type: -

Identifier Source: org_study_id

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