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

NCT01393418 | Completed

• 1 other identifier: HUM41529
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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).

Conditions

Erythropoietin; Acute Kidney Injury; Renal Biomarker

Keywords

Erythropoietin; Cardiac Surgery; Renal Biomarker; Acute Kidney Injury; Hypothermic Circulatory Arrest

Outcome Measures

Primary Outcomes (1)

• Renal injury/Failure

  18 Hours after surgery

Study Arms (1)

Subjects undergoing cardiac surgery

Other: Cardiac Surgery

Interventions

Cardiac Surgery OTHER

Subjects undergoing cardiac surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cardiac surgery patients.

You may qualify if:

• 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

You may not qualify if:

• VADS
• Emergent cases
• Prolonged hypoxemia before, during or after bypass
• End stage renal disease
• Patients receive erythropoietin receptor agonists

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan Hospital

Ann Arbor, Michigan, 48109, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Cardiac Surgical Procedures

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Thoracic Surgical Procedures

Study Officials

• Yasser El Kouatli, MD

  Department of Anesthesiology, University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Lecturer

Study Record Dates

• First Submitted: July 12, 2011
• First Posted: July 13, 2011
• Study Start: November 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: December 15, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)