[logo] HealthTree Foundation
search more_vert
close
person Sign In / Create Account
arrow_back

Go back to trials list

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


Outcome Timeframe 28 days

NCTID NCT06620523

Phases PHASE2

Primary Purpose TREATMENT

Start Date 2024-07-18

Completion Date 2027-06-17

Enrollment Target 242

Interventions

DRUG CoQ10 1200 mg orally with Glutathione 1000 mg orally

DRUG Group B: Placebo CoQ10 orally and Placebo Glutathione orally

Locations Recruiting

George Washington University Hospital

United States, District of Columbia, Washington


Interested in joining this trial?

Our dedicated patient navigators are here to guide you through the validation and enrollment process with ease.

newsletter icon

Get the latest thought leadership on your Kidney Disease delivered straight to your inbox

Subscribe to the weekly newsletter for news, stories, clinical trial updates, and helpful resources and events with cancer experts.