Evaluation of Renal Function in Subjects Who Had Undergone Cardiac Surgery

Terminated

• Conditions: Cardiac Surgery
• Interventions: Diagnostic Test: mGFR by iohexol clearance

• Registration Number: NCT04654221
• Lead Sponsor: Quark Pharmaceuticals

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.

Study Timeline

• Study Start: 2020-02-21
• Study First Submitted: 2020-11-27
• Study First Submitted QC: 2020-11-27
• Study First Posted: 2020-12-04
• Primary Completion: 2021-02-25
• Study Completion: 2021-03-26
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-12
• Last Update Posted: 2021-07-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Female, BMI <= 24.9	mGFR by iohexol clearance	Female subjects with a BMI of less than or equal to 24.9
Female, BMI 25-29	mGFR by iohexol clearance	Female subjects with a BMI of 25 to 29
Male, BMI >29	mGFR by iohexol clearance	Male subjects with a BMI of greater than 29
Male, BMI <= 24.9	mGFR by iohexol clearance	Male subjects with a BMI of less than or equal to 24.9
Female, BMI >29	mGFR by iohexol clearance	Female subjects with a BMI of greater than 29
Male, BMI 25-29	mGFR by iohexol clearance	Male subjects with a BMI of 25 to 29

Primary Outcome Measures

Name	Time	Method
Correlation between eGFR and mGFR	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.

Trial Locations

Locations (5)

CB Flock Research; 🇺🇸 Mobile, Alabama, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

Advance Medical Research; 🇺🇸 Saint Petersburg, Florida, United States

Valley Clinical Trials; 🇺🇸 Northridge, California, United States

Multi-Specialty Research Associates, Inc.; 🇺🇸 Lake City, Florida, United States