NCT07031128 Alpha Ketoglutarate Enhances Geroprotection In Surgery (AEGIS)
| NCT ID | NCT07031128 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | National University Hospital, Singapore |
| Condition | CABG |
| Study Type | INTERVENTIONAL |
| Enrollment | 250 participants |
| Start Date | 2024-06-11 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 250 participants in total. It began in 2024-06-11 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
One of the most common major surgeries that older patients undergo is coronary artery bypass grafting surgery (CABG), which is performed in approximately 400,000 patients in the United States each year. CABG invokes a massive surgical stress response, with systemic epinephrine increasing 33-fold and norepinephrine increasing 3-fold. Initially, local tissue injury results in a sterile inflammation, releasing damage-associated molecular patterns (DAMPS). DAMPS activate neutrophils, bringing a cascade of cytokines, complement, and coagulation changes. Activation of nociceptors results in a neurometabolic response involving the sympathetic nervous system and hypothalamus-pituitary axis. This brings about systemic effects including changes in basal metabolic rate, hyperglycemia, lipolysis, negative nitrogen balance, and release of cytokines and complement. Although the surgical stress response is essential for wound healing and is usually self-limiting, an exaggerated response may occur resulting in multiple organ dysfunction. The acute phase of the surgical stress response is often followed by secondary insults that may be either sterile or pathogen-induced (such as postoperative infection).In the "two-hit" model of surgical stress response, there is an exaggerated response even to minor insults in vulnerable individuals who were primed by the initial stress response. Changes in the microbiome may also occur, developing a "pathobiome" that may enter the systemic circulation. If left unchecked, this second hit may result in the development of systemic inflammatory response syndrome (SIRS) and multi-organ failure. Chronological ageing changes the innate and adaptive immunity of patients. Biological hallmarks of aging such as genomic instability, mitochondrial damage, glycation of proteins, and cellular senescence all result in increased oxidative stress and systemic inflammation. Aging brings about a pro-inflammatory innate immune responsiveness that often occurs even in the absence of an inflammatory threat. This is termed inflammaging. Paradoxically, inflammaging is associated with an increased risk of infection and poor response to stressful events. At the same time, there is an age-associated loss of T-cell function, particularly in naïve CD8 T-cells. This deficit is termed immunosenescence and is characterised by reduced pathogen recognition, chemotaxis, and phagocytosis.
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
Contact & Investigator
Lian Kah Ti
PRINCIPAL INVESTIGATOR
National University Hospital, Singapore
Frequently Asked Questions
Who can join the NCT07031128 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, studying CABG. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07031128 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07031128 currently recruiting?
Yes, NCT07031128 is actively recruiting participants. Contact the research team at anatilk@nus.edu.sg for enrollment information.
Where is the NCT07031128 trial being conducted?
This trial is being conducted at Singapore, Singapore, Singapore, Singapore.
Who is sponsoring the NCT07031128 clinical trial?
NCT07031128 is sponsored by National University Hospital, Singapore. The principal investigator is Lian Kah Ti at National University Hospital, Singapore. The trial plans to enroll 250 participants.