- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01393418
Evaluating Erythropoietin as an Indicator for Possible Kidney Injury After Cardiac Surgery (EPO)
EPO: A Renal Biomarker After Cardiac Surgery
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109
- University of Michigan Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Subjects undergoing cardiac surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Renal injury/Failure
Time Frame: 18 Hours after surgery
|
18 Hours after surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Yasser El Kouatli, MD, Department of Anesthesiology, University of Michigan
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUM41529
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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