Recruiting
Phase 2

AKI

Sponsor:

George Washington University

Code:

NCT06620523

Conditions

Renal Failure

Coronary Artery Disease

Surgery

Surgery-Complications

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

CoQ10 1200 mg orally with Glutathione 1000 mg orally

Group B: Placebo CoQ10 orally and Placebo Glutathione orally

Study Details

Brief 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.

Conditions

Renal Failure

Coronary Artery Disease

Surgery

Surgery-Complications

Study ID

NCT06620523

Start date

Jul 18, 2024

Status verified date

Oct, 2025

Completion date

Jun 17, 2028

Anticipated

Primary completion date

Jun 17, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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 Design

Enrollment

242 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Group A: CoQ10 1200 mg orally with Glutathione 1000 mg orally

White-colored CoQ10 400 mg capsules will be dispensed AND White colored L-Glutathione 500 mg capsules will be dispensed.

placebo comparator: 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.

Interventions

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

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.

Primary outcome measure

  • AKI incidence reduction [ Time Frame: 28 days ]
  • AKI incidence reduction [ Time Frame: 90 days ]

Central Contacts and Locations

Central contacts

Eduard Shaykhinurov, MS

2028234259eshaykhinurov@mfa.gwu.edu

Locations

George Washington University Hospital

Recruiting

Washington D.C., District of Columbia, United States, 20037

Contacts

Eduard Shaykhinurov

202-823-4259eshaykhinurov@mfa.gwu.edu

Principal Investigator:

Yoosif Abdalla, MD

More Information

Sponsor

George Washington University

Last update posted

Oct 8, 2025

Last verified

Oct, 2025

Keywords

  • cardiac surgery
  • critical care medicine
  • anesthesiology
  • nephrology
  • cardiopulmonary bypass
  • renal failure
  • aki
  • supplement

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by George Washington University on 2025-10-08.