Evaluation of Renal Function in Subjects Who Had Undergone Cardiac Surgery

Quark Pharmaceuticals16 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Cardiac Surgery

Interventions

mGFR by iohexol clearanceDIAGNOSTIC_TEST

Iohexol 5mL injection (300 mg iodine/mL) will be administered to all subjects to determine mGFR by iohexol clearance

Eligibility

Sex: ALLMin age: 45 Years

Medical Language ↔ Plain English

Key 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: 1. Reduced renal function 2. Diabetes with ongoing insulin treatment 3. Albuminuria * Have undergone non-emergent open chest cavity cardiovascular surgeries, with use of cardiopulmonary bypass (CPB), with or without hypothermic circulatory arrest Key Exclusion Criteria: * Emergent surgeries, including aortic dissection, and major congenital heart defects * Past cardiac surgery off CPB * Have a known allergy to iohexol

Locations (6)

CB Flock Research

Mobile, Alabama, United States

Valley Clinical Trials

Covina, California, United States

Valley Clinical Trials

Northridge, California, United States

Multi-Specialty Research Associates, Inc.

Lake City, Florida, United States

Outcomes

Primary Outcomes

Correlation between eGFR and mGFR

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.

Time frame: at 90 days post cardiac surgery

Data from ClinicalTrials.gov

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