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

Sponsor

University of Michigan (Other)

Overall Status

Completed

CT.gov ID

NCT01393418

Collaborator

(none)

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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 Design

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 :

Nov 1, 2010

Actual Primary Completion Date :

Mar 1, 2012

Actual Study Completion Date :

Mar 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Subjects undergoing cardiac surgery	Other: Cardiac Surgery

Arm

Intervention/Treatment

Subjects undergoing cardiac surgery

Other: Cardiac Surgery

Outcome Measures

Primary Outcome Measures

Renal injury/Failure [18 Hours after surgery]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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