Evaluation of Renal Function in Subjects Who Had Undergone Cardiac Surgery
NCT ID: NCT04654221
Last Updated: 2021-07-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
16 participants
OBSERVATIONAL
2020-02-21
2021-03-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Male, BMI <= 24.9
Male subjects with a BMI of less than or equal to 24.9
mGFR by iohexol clearance
Iohexol 5mL injection (300 mg iodine/mL) will be administered to all subjects to determine mGFR by iohexol clearance
Female, BMI <= 24.9
Female subjects with a BMI of less than or equal to 24.9
mGFR by iohexol clearance
Iohexol 5mL injection (300 mg iodine/mL) will be administered to all subjects to determine mGFR by iohexol clearance
Male, BMI 25-29
Male subjects with a BMI of 25 to 29
mGFR by iohexol clearance
Iohexol 5mL injection (300 mg iodine/mL) will be administered to all subjects to determine mGFR by iohexol clearance
Female, BMI 25-29
Female subjects with a BMI of 25 to 29
mGFR by iohexol clearance
Iohexol 5mL injection (300 mg iodine/mL) will be administered to all subjects to determine mGFR by iohexol clearance
Male, BMI >29
Male subjects with a BMI of greater than 29
mGFR by iohexol clearance
Iohexol 5mL injection (300 mg iodine/mL) will be administered to all subjects to determine mGFR by iohexol clearance
Female, BMI >29
Female subjects with a BMI of greater than 29
mGFR by iohexol clearance
Iohexol 5mL injection (300 mg iodine/mL) will be administered to all subjects to determine mGFR by iohexol clearance
Interventions
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mGFR by iohexol clearance
Iohexol 5mL injection (300 mg iodine/mL) will be administered to all subjects to determine mGFR by iohexol clearance
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Past cardiac surgery off CPB
* Have a known allergy to iohexol
45 Years
ALL
No
Sponsors
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Quark Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Nitsan Halevy, MD
Role: STUDY_DIRECTOR
Quark Pharmaceuticals
Locations
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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
Advance Medical Research
St. Petersburg, Florida, United States
Duke University Medical Center
Durham, North Carolina, United States
Countries
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Other Identifiers
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QRK509
Identifier Type: -
Identifier Source: org_study_id
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