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

Acute Kidney Injury Clinical Trial

— EPO  

Official title:

EPO: A Renal Biomarker After Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01393418
• Other study ID #: HUM41529
• Status: Completed
• Phase: N/A
• First received: July 12, 2011
• Last updated: December 14, 2016
• Start date: November 2010
• Est. completion date: March 2012

Study information

• Verified date: December 2016
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Acute Kidney Injury
• Erythropoietin
• Renal Biomarker
• Wounds and Injuries

Intervention

Other:
• Cardiac Surgery

Locations

Country	Name	City	State
United States	University of Michigan Hospital	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Renal injury/Failure		18 Hours after surgery	No