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RECRUITINGPhase 2INTERVENTIONAL

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)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Adult 18-70 years of age - Undergoing elective CPB (Cardiopulmonary Bypass) surgery - Baseline GFR (Glomerular Filtration Rate) ≥45 ml/min Who Should NOT Join This Trial: - GFR (Glomerular Filtration Rate) \<45 ml/min - Solitary kidney - Status post-kidney transplant - Pregnant women - Allergy to CoQ10 - Allergy to Glutathione - Allergy to Cellulose Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

CoQ10 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

DRUG

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.

Locations (1)

George Washington University Hospital
Washington D.C., District of Columbia, United States