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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yasser Kouatli, University of Michigan
ClinicalTrials.gov Identifier:
NCT01393418
First received: July 12, 2011
Last updated: December 14, 2016
Last verified: December 2016
  Purpose
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 Intervention
Erythropoietin
Acute Kidney Injury
Renal Biomarker
Other: Cardiac Surgery

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: EPO: A Renal Biomarker After Cardiac Surgery

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Renal injury/Failure [ Time Frame: 18 Hours after surgery ]

Biospecimen Retention:   Samples Without DNA
Blood

Enrollment: 80
Study Start Date: November 2010
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Subjects undergoing cardiac surgery 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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Cardiac surgery patients.
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01393418

Locations
United States, Michigan
University of Michigan Hospital
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Yasser El Kouatli, MD Department of Anesthesiology, University of Michigan
  More Information

Responsible Party: Yasser Kouatli, Clinical Lecturer, University of Michigan
ClinicalTrials.gov Identifier: NCT01393418     History of Changes
Other Study ID Numbers: HUM41529 
Study First Received: July 12, 2011
Last Updated: December 14, 2016
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by University of Michigan:
Erythropoietin
Cardiac Surgery
Renal Biomarker
Acute Kidney Injury
Hypothermic Circulatory Arrest

Additional relevant MeSH terms:
Wounds and Injuries
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Epoetin Alfa
Hematinics

ClinicalTrials.gov processed this record on February 20, 2017