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Completed

NCT Number: NCT01393418

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

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).

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Key information

Conditions

Erythropoietin Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Biomarker Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Michigan Hospital

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cardiac Surgery

Other

Primary outcomes

  1. Renal injury/Failure

    Time frame: 18 Hours after surgery

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

EPO: A Renal Biomarker After Cardiac Surgery

Acronym: EPO

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jul 13, 2011
Registry last updated
Dec 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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