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

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

Inclusion Criteria3

  • Adult 18-70 years of age
  • Undergoing elective CPB (Cardiopulmonary Bypass) surgery
  • Baseline GFR (Glomerular Filtration Rate) ≥45 ml/min

Exclusion Criteria7

  • GFR (Glomerular Filtration Rate) \<45 ml/min
  • Solitary kidney
  • Status post-kidney transplant
  • Pregnant women
  • Allergy to CoQ10
  • Allergy to Glutathione
  • Allergy to Cellulose

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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