Alpha-ketoglutarate to improve recovery after coronary artery bypass

Evaluating the Impact of Alpha Ketoglutarate (AKG), a Geroprotector, in Reducing Morbidity and Improving Patient-Centred Outcomes After Coronary Artery Bypass Grafting Surgery in Resilient and Poorly-Resilient Patients: A Double-Blind Placebo-Controlled Clinical Trial

This trial will try giving alpha-ketoglutarate around the time of elective CABG to see if it reduces an exaggerated immune response and helps people aged 50 and older recover faster.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 250 (estimated)
• Ages: 50 Years and up
• Sex: All
• Sponsor: National University Hospital, Singapore (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 2 sites (Singapore, Singapore and 1 other locations)
• Trial ID: NCT07031128 on ClinicalTrials.gov

What this trial studies

This randomized, placebo-controlled Phase 4 trial gives alpha-ketoglutarate or matching placebo in the perioperative period to patients aged 50 and over undergoing elective CABG with cardiopulmonary bypass. Blood immune profiling including single-cell mass cytometry will be used before and after surgery to measure changes in immune cell signalling and inflammatory markers. Clinical recovery outcomes such as fatigue, pain, functional impairment, surgical site complications and organ dysfunction will be recorded and correlated with immune signatures. Key exclusions include current AKG use, active infection, recent cancer therapy, planned immunosuppression, certain psychiatric disorders, and pregnancy or breastfeeding.

Who should consider this trial

Good fit: Ideal candidates are people aged 50 or older scheduled for elective CABG with cardiopulmonary bypass who are not already taking AKG and can give informed consent.

Not a fit: Patients who are immunocompromised, actively infected, receiving chemotherapy or immunosuppressants, pregnant or already taking AKG are excluded and therefore would not be expected to benefit from participation.

Why it matters

Potential benefit: If successful, perioperative AKG could blunt harmful postoperative inflammation and speed functional recovery, lowering complications after CABG.

How similar studies have performed: Prior work has shown that preoperative and postoperative immune profiles predict recovery after surgery, but perioperative use of alpha-ketoglutarate as a geroprotector is a relatively new clinical approach with limited trial evidence to date.

Eligibility criteria

Inclusion Criteria

1. Scheduled for elective CABG with cardiopulmonary bypass
2. Aged 50 years and above
3. Adequate cognitive function to be able to give informed consent

Exclusion Criteria

1. Patients already taking AKG as a supplement
2. Substance abuse disorder either untreated or treated
3. Post-traumatic stress disorder, bipolar disorder, Schizophrenia, or any other untreated or poorly controlled mental health or mood disorder, or history of hospitalization due to mental health condition in the past 3 years, cognitively impaired patients
4. HIV/AIDS
5. Patients undergoing or scheduled to undergo chemotherapy or any other treatment for malignancy
6. Patients scheduled for immunosuppressant therapy for transplant
7. Patients with an active infection requiring antibiotic or antiviral therapy
8. Pregnant women / planning to conceive / breastfeeding women
9. Patients who are taking chronic anti-inflammatory drugs e.g., NSAIDS
10. Patients who are hypersensitivity to AKG or placebo or any components of the respective tablets to be administered

Where this trial is running

Singapore, Singapore and 1 other locations

• National University Hospital — Singapore, Singapore, Singapore (Recruiting)
• Singapore General Hospital — Singapore, Singapore (Recruiting)

Study contacts

• Principal investigator: Lian Kah Ti — National University Hospital, Singapore
• Study coordinator: Lian Kah Ti

Conditions CABG; Geroprotector; Alpha-ketoglutarate