Study Stopped
Study terminated early due to program discontinuation.
Evaluation of Renal Function in Subjects Who Had Undergone Cardiac Surgery
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
1 other identifier
observational
16
1 country
6
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Feb 2020
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 21, 2020
CompletedFirst Submitted
Initial submission to the registry
November 27, 2020
CompletedFirst Posted
Study publicly available on registry
December 4, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 25, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 26, 2021
CompletedJuly 16, 2021
July 1, 2021
1 year
November 27, 2020
July 12, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
at 90 days post cardiac surgery
Study Arms (6)
Male, BMI <= 24.9
Male subjects with a BMI of less than or equal to 24.9
Female, BMI <= 24.9
Female subjects with a BMI of less than or equal to 24.9
Male, BMI 25-29
Male subjects with a BMI of 25 to 29
Female, BMI 25-29
Female subjects with a BMI of 25 to 29
Male, BMI >29
Male subjects with a BMI of greater than 29
Female, BMI >29
Female subjects with a BMI of greater than 29
Interventions
Iohexol 5mL injection (300 mg iodine/mL) will be administered to all subjects to determine mGFR by iohexol clearance
Eligibility Criteria
Subjects who have undergone non-emergent cardiac surgery and were at high risk of developing AKI, who meet all of the Inclusion and none of the Exclusion criteria, will be eligible.
You may qualify if:
- 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
You may not qualify if:
- Emergent surgeries, including aortic dissection, and major congenital heart defects
- Past cardiac surgery off CPB
- Have a known allergy to iohexol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
CB Flock Research
Mobile, Alabama, 36608, United States
Valley Clinical Trials
Covina, California, 91723, United States
Valley Clinical Trials
Northridge, California, 91325, United States
Multi-Specialty Research Associates, Inc.
Lake City, Florida, 32055, United States
Advance Medical Research
St. Petersburg, Florida, 33713, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Nitsan Halevy, MD
Quark Pharmaceuticals
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 27, 2020
First Posted
December 4, 2020
Study Start
February 21, 2020
Primary Completion
February 25, 2021
Study Completion
March 26, 2021
Last Updated
July 16, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will not share