Evaluating Erythropoietin as an Indicator for Possible Kidney Injury After Cardiac Surgery (EPO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01393418
Recruitment Status : Completed
First Posted : July 13, 2011
Last Update Posted : December 15, 2016
Information provided by (Responsible Party):
Yasser Kouatli, University of Michigan

Brief Summary:
The purpose of the study is to evaluate kidney biomarkers and determine if there is a correlation between Erythropoietin (EPO) levels and acute kidney injury after cardiac surgery. An early biomarker for kidney injury may be helpful in identifying, monitoring and managing patients at risk for kidney failure after cardiac surgery. To evaluate Erythropoietin's role as a predictor of poor renal function in the immediate post-bypass period we plan to compare EPO levels to Neutrophil gelatinase-associated lipocalin (NGAL).

Condition or disease Intervention/treatment
Erythropoietin Acute Kidney Injury Renal Biomarker Other: Cardiac Surgery

Detailed Description:

Acute kidney injury (AKI) is a serious complication after cardiac surgery and cardio-pulmonary bypass. AKI is associated with high mortality.

Erythropoietin, a hormone produced by the kidneys, will be evaluated as a potential biomarker of kidney injury. Neutrophil gelatinase-associated lipocalin (NGAL) has been studied as a biomarker of kidney injury. Early kidney injury detection has been long sought and NGAL has been shown to be a promising biomarker. A troponinlike biomarker of AKI that is easily measured and capable of both early detection and risk stratification would represent an advancement in our ability to differentiate acute kidney injury from failure.

Investigating EPO as a biomarker may prove to have increased predictive value in the clinical care of cardiac surgery patients.

Study Type : Observational
Actual Enrollment : 80 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: EPO: A Renal Biomarker After Cardiac Surgery
Study Start Date : November 2010
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery
U.S. FDA Resources

Group/Cohort Intervention/treatment
Subjects undergoing cardiac surgery Other: Cardiac Surgery

Primary Outcome Measures :
  1. Renal injury/Failure [ Time Frame: 18 Hours after surgery ]

Biospecimen Retention:   Samples Without DNA

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Cardiac surgery patients.

Inclusion Criteria:

  • Cardiac surgery with cardiopulmonary bypass with DHCA
  • Normal renal function or renal insufficiency-serum creatinine less than 2.5 mg/dL
  • Adult male and female patients 18 years and older

Exclusion Criteria:

  • VADS
  • Emergent cases
  • Prolonged hypoxemia before, during or after bypass
  • End stage renal disease
  • Patients receive erythropoietin receptor agonists

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01393418

United States, Michigan
University of Michigan Hospital
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Principal Investigator: Yasser El Kouatli, MD Department of Anesthesiology, University of Michigan

Responsible Party: Yasser Kouatli, Clinical Lecturer, University of Michigan Identifier: NCT01393418     History of Changes
Other Study ID Numbers: HUM41529
First Posted: July 13, 2011    Key Record Dates
Last Update Posted: December 15, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Yasser Kouatli, University of Michigan:
Cardiac Surgery
Renal Biomarker
Acute Kidney Injury
Hypothermic Circulatory Arrest

Additional relevant MeSH terms:
Wounds and Injuries
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Epoetin Alfa