Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 18 to 70

Preventing kidney injury after heart surgery

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

Run by George Washington University · NCT06620523 · Data updated 2026-11-12

This study is testing if Coenzyme Q10 and Glutathione can help prevent kidney injury in patients having heart surgery.

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years to 70 Years
SexAll
Enrollment242 (estimated)
SponsorGeorge Washington University
Academic / other
Locations1 site (Washington D.C., District of Columbia)
StatusRecruiting
StartedJuly 18, 2024
Main results expectedJune 17, 2027
Study endsJune 17, 2028
Registry record updatedOctober 14, 2026
Trial IDNCT06620523 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18-70 who are scheduled for elective cardiopulmonary bypass surgery with a baseline GFR of 45 ml/min or higher.

Probably not a fit

Patients with a GFR below 45 ml/min, those with a solitary kidney, or individuals who have undergone kidney transplant will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial investigates the effectiveness of Coenzyme Q10 and Glutathione in preventing acute kidney injury (AKI) in patients undergoing elective cardiac surgery with cardiopulmonary bypass. A total of 242 participants will be randomly assigned to receive either the active treatment or a placebo, starting the day before surgery and continuing for up to one week post-operation. Blood and urine samples will be collected to monitor kidney function and any adverse effects related to the treatments. The study aims to address the high incidence of AKI following cardiac surgery, which can lead to severe complications and long-term health issues.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the incidence of acute kidney injury in patients undergoing cardiac surgery, improving overall patient outcomes.

How similar studies have gone: While the approach of using CoQ10 and Glutathione for this purpose is innovative, similar studies targeting AKI prevention in cardiac surgery have shown varying degrees of success.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

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

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.