The purpose of this study is to evaluate the effect of RBT-1 on reducing the risk of post-operative complications in subjects undergoing cardiac surgery on cardiopulmonary bypass (CPB). A sub-study will also be conducted to evaluate the pharmacokinetic (PK) profile of a single administration of RBT-1 by means of a popPK approach in subjects scheduled to undergo cardiac surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
454
Hierarchical composite of the following outcomes: death, incidence of AKI requiring dialysis, 30-day cardiopulmonary readmission, and intensive care unit (ICU days).
The analysis will be based on a "win ratio," which uses the Finkelstein-Schoenfeld method wherein all RBT-1 patients are paired with all placebo patients; each pair is declared to be a win for RBT-1, a win for placebo, or a tie, based on the hierarchical composite. The win ratio is the ratio of the number of wins for RBT-1 divided by the number of wins for placebo.
Time frame: Index hospitalization (ie, hospitalization post-cardiac surgery up to 60 days) or within 30-days post-discharge, as applicable
Composite of the Number of Post-operative Complications
The number of the following post-operative complications per patient will be assessed: * Death * AKI requiring dialysis * \>3 days in ICU * \>24 hours on ventilator * 30-day cardiopulmonary readmission * Need for blood transfusion during index hospitalization * New-onset atrial fibrillation during index hospitalization
Time frame: Index hospitalization (ie, hospitalization post-cardiac surgery up to 60 days) or within 30-days post-discharge, as applicable
ICU Days
Days in ICU
Time frame: Index hospitalization (ie, hospitalization post-cardiac surgery up to 60 days)
30-day Cardiopulmonary Readmission Rates
Readmissions due to cardiopulmonary reasons
Time frame: Within 30-days post-discharge
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Research Site
Huntsville, Alabama, United States
Research Site
La Jolla, California, United States
Research Site
San Francisco, California, United States
Research Site
Stanford, California, United States
Research Site
Washington D.C., District of Columbia, United States
Research Site
Atlantis, Florida, United States
Research Site
Gainesville, Florida, United States
Research Site
Athens, Georgia, United States
Research Site
Atlanta, Georgia, United States
Research Site
Fort Wayne, Indiana, United States
...and 31 more locations