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

NCT ID: NCT01393418

Last Updated: 2016-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-11-30

Study Completion Date

2012-03-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Erythropoietin Acute Kidney Injury Renal Biomarker

Keywords

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Erythropoietin Cardiac Surgery Renal Biomarker Acute Kidney Injury Hypothermic Circulatory Arrest

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Subjects undergoing cardiac surgery

Cardiac Surgery

Intervention Type OTHER

Interventions

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Cardiac Surgery

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Yasser Kouatli

Clinical Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yasser El Kouatli, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology, University of Michigan

Locations

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University of Michigan Hospital

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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HUM41529

Identifier Type: -

Identifier Source: org_study_id