The purpose of this study is to evaluate the effect of RBT-1 (stannous protoporphyrin \[SnPP\]/iron sucrose \[FeS\]) on preconditioning response biomarkers in subjects who are at risk for AKI following cardiac surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
152
intravenous administration
intravenous administration
intravenous administration
Evaluate the Efficacy of RBT-1 in Generating a Preconditioning Response as Measured by a Composite of Biomarkers
Composite of the geometric mean of the ratios of the maximum PreOp value over Baseline for plasma heme oxygenase-1 (HO-1), ferritin, and interleukin-10 (IL-10)
Time frame: Baseline through Pre-Surgery
Change in Renal Tubular Injury Biomarkers
Geometric mean of the ratios of the maximum PostOp value over Baseline for urine KIM-1, NGAL, and cystatin C.
Time frame: Baseline through Day 3 post-cardiac surgery
Number of Subjects With Reduction in Urine Output
Documented AE of sustained reduction in urine output, oliguria, or anuria post-cardiac surgery through Day 5
Time frame: Baseline through post-cardiac surgery through Day 5
Number of Subjects With Acute Kidney Injury (AKI)
AKI is defined using the KDIGO criteria (ie, an absolute increase in serum creatinine of ≥1.5 × Baseline; or documented AE of sustained reduction in urine output, oliguria, or anuria; or initiation of dialysis).
Time frame: Baseline through Day 5 post-cardiac surgery
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Heart Center Research, LLC
Huntsville, Alabama, United States
Keck Hospital of USC
Los Angeles, California, United States
Santa Barbara Cottage Hospital
Santa Barbara, California, United States
Stanford University Medical Center
Stanford, California, United States
Yale University School of Medicine
New Haven, Connecticut, United States
MedStar Health Research Institute, Inc.
Washington D.C., District of Columbia, United States
University of Chicago Hospital Anesthesia and Critical Care
Chicago, Illinois, United States
Indiana University Health Southern Indiana
Bloomington, Indiana, United States
Lutheran Medical Group
Fort Wayne, Indiana, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
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