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Efficacy of Mitochondrial Directed Therapy in Prevention of Cardiac Surgery Associated AKI Prevent Cardiac Surgery Associated AKI Trial (Prevent CSA-AKI Trial)
Description
Prevent CSA-AKI (Cardiac Surgery Associated Acute Kidney Injury) trial is a double blinded randomized controlled trial, 242 patients undergoing elective cardiopulmonary bypass surgery (CPB)will either receive a placebo or daily 1200 mg of Co enzyme Q10 (CoQ10) and 1000 mg of Glutathione (GSH), the first dose will be given the day before surgery and continues while admitted up to 1 week. Blood and urine samples will be collected. Adverse events related to the study drugs will be collected.AKI (Acute Kidney Injury) is a serious and common complication post Cardiac surgery requiring cardiopulmonary bypass (CPB), the incidence is up to 30% Independent predictor for 30-day mortality, with a 41 % \& % 62% in AKI stage III without and with the needs for RRT (Renal Replacement Therapy) respectively It's also associated with an a 3-fold increase in the long-term risk of ESRD (End Stage Renal Disease) Despite the high burden of CPB-induced AKI, our understanding of the pathophysiology still prim
Trial Eligibility
Inclusion Criteria: * Adult 18-70 years of age * Undergoing elective CPB (Cardiopulmonary Bypass) surgery * Baseline GFR (Glomerular Filtration Rate) ≥45 ml/min Exclusion Criteria: * GFR (Glomerular Filtration Rate) \<45 ml/min * Solitary kidney * Status post-kidney transplant * Pregnant women * Allergy to CoQ10 * Allergy to Glutathione * Allergy to Cellulose
Study Info
Organization
George Washington University
Primary Outcome
AKI incidence reduction
Interventions
Locations Recruiting
George Washington University Hospital
United States, District of Columbia, Washington
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