Actively Recruiting
Efficacy of Mitochondrial Directed Therapy in Prevention of Cardiac Surgery Associated AKI Prevent Cardiac Surgery Associated AKI Trial
Led by George Washington University · Updated on 2025-10-08
242
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of mitochondrial-directed therapy to prevent acute kidney injury (AKI) associated with cardiac surgery involving cardiopulmonary bypass (CPB). This trial focuses on adults undergoing elective CPB surgery who are at risk of AKI, a serious complication linked to increased mortality and long-term kidney disease. The study explores the role of mitochondrial dysfunction in AKI development and tests therapies aimed at protecting kidney function during surgery. Participants will be randomly assigned to receive either a combination of Coenzyme Q10 (CoQ10) at 1200 mg daily and Glutathione (GSH) at 1000 mg daily, or matching placebos. The first dose is given the day before surgery and continued daily while admitted, for up to one week. CoQ10 and Glutathione are supplements thought to protect mitochondria and reduce oxidative stress. The placebo capsules are designed to look identical to the active treatments. During the study, blood and urine samples will be collected to monitor kidney function and any side effects. Researchers will track the incidence of AKI up to 28 and 90 days after surgery to assess treatment impact. Safety is monitored by recording any adverse events related to the study drugs. The trial involves regular assessments while admitted and follow-up to evaluate kidney outcomes over several months.
CONDITIONS
Brief Title
Prevent Cardiac Surgery Associated AKI Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 70 years
- Scheduled for elective cardiopulmonary bypass surgery
- Baseline glomerular filtration rate (GFR) of 45 ml/min or higher
You will not qualify if you...
- Glomerular filtration rate (GFR) below 45 ml/min
- Having only one kidney
- Previous kidney transplant
- Pregnant women
- Allergy to Coenzyme Q10
- Allergy to Glutathione
- Allergy to Cellulose
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 28 days
Participants receive either CoQ10 and Glutathione supplements or matching placebos to assess their effectiveness in preventing acute kidney injury associated with cardiac surgery.
1 baseline visit and multiple follow-up visits during the treatment period
Duration - Up to 90 days after treatment
Participants are monitored for up to 90 days to evaluate the incidence of acute kidney injury after the treatment period.
Periodic visits depending on clinical assessments
Trial Site Locations
Total: 1 location
1
George Washington University Hospital
Washington D.C., District of Columbia, United States, 20037
Actively Recruiting
Research Team
E
Eduard Shaykhinurov, MS
Y
Yoosif Abdalla, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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