Efficacy of Mitochondrial Directed Therapy in Prevention of Cardiac Surgery Associated AKI Prevent Cardiac Surgery Associated AKI Trial (Prevent CSA-AKI Trial)
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• Adult 18-70 years of age
• Undergoing elective CPB (Cardiopulmonary Bypass) surgery
• Baseline GFR (Glomerular Filtration Rate) ≥45 ml/min
Locations
United States
Washington, D.c.
George Washington University Hospital
RECRUITING
Washington D.c.
Contact Information
Primary
Eduard Shaykhinurov, MS
eshaykhinurov@mfa.gwu.edu
2028234259
Backup
Yoosif Abdalla, MD
Time Frame
Start Date: 2024-07-18
Estimated Completion Date: 2028-06-17
Participants
Target number of participants: 242
Treatments
Active_comparator: Group A: CoQ10 1200 mg orally with Glutathione 1000 mg orally
White-colored CoQ10 400 mg capsules will be dispensed AND White colored L-Glutathione 500 mg capsules will be dispensed.
Placebo_comparator: Group B: Placebo CoQ10 orally and Placebo Glutathione orally
A placebo to exactly match the CoQ10 will be made with white gelatin empty capsules containing cellulose AND a placebo to exactly match the L-Glutathione will be made with white gelatin empty capsules containing cellulose.
Related Therapeutic Areas
Sponsors
Leads: George Washington University