Evaluating Erythropoietin as an Indicator for Possible Kidney Injury After Cardiac Surgery (EPO)
Recruitment status was Recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of the study is to evaluate kidney biomarkers and determine if there is a correlation between erythropoietin 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 EPO's role as a predictor of poor renal function in the immediate post-bypass period we plan to compare EPO levels to NGAL.
| Condition |
|---|
|
Erythropoietin Acute Kidney Injury Renal Biomarker |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Cross-Sectional |
| Official Title: | EPO: A Renal Biomarker After Cardiac Surgery |
Blood
| Estimated Enrollment: | 80 |
| Study Start Date: | November 2010 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
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 |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Cardiac surgery patients.
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| Contact: Theresa Shields, RN, BSN | 734 232-5205 | shieldt@med.umich.edu |
| United States, Michigan | |
| University of Michigan Hospital | Recruiting |
| Ann Arbor, Michigan, United States, 48109 | |
| Principal Investigator: Yasser El Kouatli, MD | |
| Principal Investigator: | Yasser El Kouatli, MD | Department of Anesthesiology, University of Michigan |
More Information
No publications provided
| Responsible Party: | Yasser El Kouatli/M.D., UmichiganHS |
| ClinicalTrials.gov Identifier: | NCT01393418 History of Changes |
| Other Study ID Numbers: | HUM41529 |
| Study First Received: | July 12, 2011 |
| Last Updated: | July 12, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Michigan Health System:
|
Erythropoietin Cardiac Surgery Renal Biomarker Acute Kidney Injury Hypothermic Circulatory Arrest |
Additional relevant MeSH terms:
|
Acute Kidney Injury Renal Insufficiency Kidney Diseases Urologic Diseases Epoetin Alfa |
Hematinics Hematologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013