Preventing kidney injury after heart surgery
Efficacy of Mitochondrial Directed Therapy in Prevention of Cardiac Surgery Associated AKI Prevent Cardiac Surgery Associated AKI Trial (Prevent CSA-AKI Trial)
This study is testing if Coenzyme Q10 and Glutathione can help prevent kidney injury in patients having heart surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 242 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | George Washington University Academic / other |
| Locations | 1 site (Washington D.C., District of Columbia) |
| Trial ID | NCT06620523 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Washington D.C., District of Columbia
- George Washington University Hospital — Washington D.C., District of Columbia, United States (Recruiting)
Study contacts
- Principal investigator: Yoosif Abdalla, MD — George Washington University
- Study coordinator: Eduard Shaykhinurov, MS
- Email: eshaykhinurov@mfa.gwu.edu
- Phone: 2028234259
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.