Evaluation of eGFR, Determined by Cystatin C and Creatinine, and mGFR, Measured by Iohexol Clearance, in Subjects at High Risk for Acute Kidney Injury (AKI) Following Cardiac Surgery
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cardiac Surgery
- Sponsor
- Quark Pharmaceuticals
- Enrollment
- 16
- Locations
- 5
- Primary Endpoint
- Correlation between eGFR and mGFR
- Status
- Terminated
- Last Updated
- 4 years ago
Overview
Brief Summary
To evaluate the differences between serum cystatin C based estimated glomerular filtration rate (eGFRcys), serum creatinine based eGFR (eGFRcreat) and measured glomerular filtration rate (mGFR) in subjects at high risk for acute kidney injury (AKI) approximately 90 days following cardiac surgery
Detailed Description
This is an open label, single-visit study to evaluate the relationship between mGFR and eGFR based either on serum creatinine (eGFRcreat) or cystatin C (eGFRcys) approximately 90 days following cardiac surgery. No investigational study drug will be administered.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female, age ≥ 45 years old
- •At risk for AKI following cardiac surgery on the basis of at least one of the following pre-operatively assessed risk factors:
- •Reduced renal function
- •Diabetes with ongoing insulin treatment
- •Albuminuria
- •Have undergone non-emergent open chest cavity cardiovascular surgeries, with use of cardiopulmonary bypass (CPB), with or without hypothermic circulatory arrest
Exclusion Criteria
- •Emergent surgeries, including aortic dissection, and major congenital heart defects
- •Past cardiac surgery off CPB
- •Have a known allergy to iohexol
Outcomes
Primary Outcomes
Correlation between eGFR and mGFR
Time Frame: at 90 days post cardiac surgery
The primary measure will be the comparison of the P(30) and P(10) between eGFR based on serum cystatin C (eGFRcys) and eGFR based on serum creatinine (eGFRcreat). P(30) and P(10) are defined as the percentage of subjects whose eGFR is within 30% (10%) of the iohexol-based mGFR.