NCT00654992

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 9, 2008

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
5 months until next milestone

Results Posted

Study results publicly available

June 16, 2009

Completed
Last Updated

June 16, 2009

Status Verified

April 1, 2009

Enrollment Period

1.4 years

First QC Date

April 4, 2008

Results QC Date

March 17, 2009

Last Update Submit

April 28, 2009

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Who Had AKI (Acute Kidney Injury)

    number of participants who had 50% increase in serum creatinine levels from baseline

    at any time within the first 5 days after surgery

Secondary Outcomes (1)

  • Change in Estimated Glomerular Filtration Rate (eGFR)

    during the first 5 days after surgery

Study Arms (2)

EPO group

ACTIVE COMPARATOR
Drug: Erythropoietin-Beta

Placebo group

PLACEBO COMPARATOR
Drug: Normal Saline

Interventions

300 IU/kg of EPO or saline intravenously before surgery

Also known as: recormon
EPO group

300 IU/kg of normal saline intravenously before surgery

Also known as: 0.9% saline
Placebo group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients scheduled for elective CABG over age 18

You may not qualify if:

  • Under age 18
  • Emergent CABG
  • Prior exposure to nephrotoxic drug
  • Dialysis patients
  • Uncontrolled hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

epoetin betaSaline Solution

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Results Point of Contact

Title
Effect of erythropoietin in kidney after cardiac surgery
Organization
Seoul National University Bundang Hospital

Study Officials

  • Ki Young, Na, MD PhD

    Department of Internal Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

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

Study Record Dates

First Submitted

April 4, 2008

First Posted

April 9, 2008

Study Start

September 1, 2006

Primary Completion

February 1, 2008

Study Completion

February 1, 2009

Last Updated

June 16, 2009

Results First Posted

June 16, 2009

Record last verified: 2009-04

Locations