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RecruitingPhase 2NCT06620523

Prevent Cardiac Surgery Associated AKI Trial

Efficacy of Mitochondrial Directed Therapy in Prevention of Cardiac Surgery Associated AKI Prevent Cardiac Surgery Associated AKI Trial (Prevent CSA-AKI Trial)

Sponsor

George Washington University

Enrollment

242 participants

Start Date

Jul 18, 2024

Study Type

INTERVENTIONAL

Conditions

SurgeryCoronary Artery DiseaseRenal Failure

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

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether a combination of CoQ10 and glutathione — two natural antioxidants — can protect the kidneys from damage during heart bypass surgery (cardiopulmonary bypass, or CPB). Acute kidney injury (AKI) is a known complication of cardiac surgery, and this study aims to see if these supplements can reduce that risk. **You may be eligible if...** - You are between 18 and 70 years old - You are scheduled for elective (non-emergency) heart surgery using cardiopulmonary bypass - Your kidney function is reasonably good (filtration rate, GFR, of at least 45 mL/min) **You may NOT be eligible if...** - Your kidney function is already significantly reduced (GFR under 45 mL/min) - You have only one kidney - You have had a kidney transplant - You are pregnant - You have a known allergy to CoQ10, glutathione, or cellulose Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCoQ10 1200 mg orally with Glutathione 1000 mg orally

This is the intervention to assess efficacy of CoQ10 and Glutathione in prevention of cardiac surgery associated acute kidney injury

DRUGGroup 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.

Locations(1)

George Washington University Hospital

Washington D.C., District of Columbia, United States

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NCT06620523

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