CABGPhase 4NCT07031128
Alpha Ketoglutarate Enhances Geroprotection In Surgery (AEGIS)
A Phase 4 study testing Alpha-ketoglutarate in people with CABG, run by National University Hospital, Singapore at 2 sites in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- CABG
- What is being tested?
- Alpha-ketoglutarate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 2 sitesSingapore
- Study dates
- 11 Jun 2024to Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled for elective CABG with cardiopulmonary bypass
- Aged 50 years and above
- Adequate cognitive function to be able to give informed consent
Who cannot join
- Patients already taking AKG as a supplement
- Substance abuse disorder either untreated or treated
- 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
- HIV/AIDS
- Patients undergoing or scheduled to undergo chemotherapy or any other treatment for malignancy
- Patients scheduled for immunosuppressant therapy for transplant
Show all 10Show fewer
- Patients with an active infection requiring antibiotic or antiviral therapy
- Pregnant women / planning to conceive / breastfeeding women
- Patients who are taking chronic anti-inflammatory drugs e.g., NSAIDS
- Patients who are hypersensitivity to AKG or placebo or any components of the respective tablets to be administered
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore2 sites, 2 recruiting
- Recruiting
National University Hospital
Singapore, Singapore, 119074
Lian Kah Ti, anatilk@nus.edu.sg
- Recruiting
Singapore General Hospital
Singapore
Sophia Tsong Huey Chew
About this study
Official title: 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
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.
Read the detailed description
Within 24 hours of surgery, single-cell mass cytometry identified signalling changes in immune cell subsets that characterise the phenotypic and functional immune response to surgery. These signals accounted for 40-60% of observed patient variability, and strong correlations were found between these immune signatures with the speed of recovery from fatigue, pain, and functional impairment. In another study, Fragiadakis found that the preoperative immune state was also predictive of recovery from surgery, with toll-like receptor (TLR) 4 signalling in cluster of differentiation (CD) 14+ monocytes accounting for 50% of observed variance in clinical recovery. Furthermore, the group showed that patients undergoing an intermediate risk cardiac surgery had a significantly higher risk of developing multi-organ failure when their cytokine response profile was highly proinflammatory after stimulation with Escherichia coli-derived lipopolysaccharide . Another study showed that patients' immune response after surgery and immune profile before surgery predicted the development of surgical site complications in abdominal surgery. Taken together, these studies were consistent in suggesting that immune profiles play a major role in surgical resilience.
Therefore, it is postulated that giving a geroprotector in the perioperative period can mitigate the aging-related immune changes and prevent a dysfunctional surgical stress response, directly impacting surgical resilience. AKG is a geroprotector that benefits patients undergoing cardiac surgery. Plasma concentrations of AKG are reduced in patients with ischemic heart disease and it is possible that this aggravates myocardial ischemic injury during CABG. AKG supplementation during cardiopulmonary bypass significantly decreased ischaemic injury markers (creatine kinase MB and troponin T) by 30-50% in patients undergoing heart surgery, secondary to improved myocardial oxygen extraction.
AKG has beneficial effects beyond its cardiac effects. AKG is an intermediate in the Krebs cycle which is involved in various metabolic and cellular pathways as a signalling molecule, energy source, and precursor of amino acid synthesis. AKG is an anti-oxidative agent and a significant source of cellular adenosine triphosphate (ATP). Therefore, AKG plays an important role in multiple metabolic processes, and has been shown to preserve skeletal muscle, improve renal function, and protect neurological function. AKG is also a regulator of cell signalling pathways that maintain energy homeostasis, including mechanistic target of rapamycin (mTOR) and AMP-activated protein kinase (AMPK). By reducing the triggers of oxidative stress and hypoxia, AKG can moderate inflammation. AKG also has immune-modulatory properties. It modulates monocyte and neutrophil function by increasing phagocytosis and reactive oxygen species (ROS) intermediate production, macrophages by enhancing cytokine production, and lymphocytes by enhancing their proliferation.
Hypothesis Inflammaging and immunosenescence renders the older patient vulnerable to a dysfunctional surgical stress response.
- Conditions
- CABG
- Being tested
- Alpha-ketoglutarate, Placebo
- Keywords
- Geroprotector, Alpha-ketoglutarate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alpha-ketoglutarateDietary supplement
Alpha-ketoglutarate supplements
PlaceboDietary supplement
Placebo tablets
| Study group | Role | What they receive |
|---|---|---|
| AKG | Experimental | To receive AKG tablets (1g a day, once a day, taken orally) Receives: Dietary Supplement: Alpha-ketoglutarate |
| Placebo | Placebo comparator | To receive placebo tablets (1g a day, once a day, taken orally) Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of systemic inflammatory response syndrome (SIRS) and at least 1 organ system
The primary outcome will be a composite of systemic inflammatory response syndrome (SIRS) and at least 1 organ system dysfunction in the systems below.
- SIRS; and
- Cardiovascular dysfunction; and/or
- Neurologic dysfunction; and or
- Renal dysfunction; and/or
- Respiratory dysfunction; and or
- Coagulation dysfunction
Measured: Postoperative till day 90
Secondary outcomes (19)
Other Clinical Outcomes which may be impacted by AKG - Muscle Mass
- Circumferential measurements of arms and calves in cm
- Triceps fold thickness in cm
Measured: Postoperative till day 90
Other Clinical Outcomes which may be impacted by AKG - Muscle Strength
- Hand grip strength in kg
Measured: Postoperative till day 90
Other Clinical Outcomes which may be impacted by AKG - Infections Acquired
- Surgical site infection: observational \& charting review
- Hospital-acquired infection: observational \& charting review
Measured: Postoperative till day 90
Other Clinical Outcomes which may be impacted by AKG - Long-term Outcomes
- Inflammation
- Cardiac
- Neurological
- Renal
Long-term Outcomes will be determined by charting reviews to determine if there are failure of the above listed organ systems
Measured: Postoperative till day 90
Other Clinical Outcomes which may be impacted by AKG - Mortality
- Mortality from any cause
To be determined by charting reviews and observation
Measured: Postoperative till day 90
Resource Utilization - Length of stay
- ICU length of stay (days)
- Hospital length of stay (days)
To be determined by charting reviews and observation
Measured: Postoperative till day 90
Resource Utilization - Discharge
- Patient discharge location
To be determined by charting reviews
Measured: Postoperative till day 90
Resource Utilization - Unplanned readmission
- Unplanning readmission from any cause
To be determined by charting reviews
Measured: Postoperative till day 90
Resource Utilization - Hospital bill size
- Cost of hospital stay (SGD) To be determined by charting reviews and requesting bill information from participants
Measured: Postoperative till day 90
Biological Ageing - Methylation & Dynamic Clocks
Various computer algorithms will be used to determine DNA methylation status
Measured: Postoperative till day 90
Identification of Immune or Inflammatory Markers
Blood samples will be collected and laboratory tests will be conducted to identify immune and inflammatory biomarkers.
Known inflammatory biomarkers such as CRP, IL-6, TNF-α,IL-1α,IL-10 and IL-8 (not exhaustive) and newly identified biomarkers will be investigated to look at how CABG surgery changes a patient's frailty status and whether AKG has an impact on these biomarkers.
Measured: Postoperative till day 90
Investigations on Immune Reactivity's Relation with Surgical Resilience
- To systematically address the endogenous signalling pathways conferring resilience of immune cells from patients with and without AKG treatments, peripheral blood mononuclear cells (PBMCs) will be stimulated with a panel of agonists that activate different toll-like receptors. Multiplexed cytokine analysis will be conducted on stimulated and control PBMCs. High dimensional, subset-specific, flow cytometry will be utilized at all points to assess changes in surface markers that indicate immune activation, immune regulation and senescence/exhaustion.
Measured: Postoperative till day 90
Patient-Centred Outcomes - Frailty
The study team will determine the patient's frailty based on observation, charting reviews and available clinical information.
Measured: Postoperative till day 90
Patient-Centred Outcomes - Pain
- Self-reported pain scores at rest and on movement using visual analogue scale (0 - 10)
Measured: Postoperative till day 90
Patient-Centred Outcomes - Disability
Study team will determine the patient's diability status base on observation. This will be conducted pre- and post- operation to determine if there is any changes in disability status due to operation, and if and how AKG has impacted this status.
Measured: Postoperative till day 90
Patient-Centred Outcomes - Quality of Life
- EuroQol 5 Dimension (EQ-5D)
Measured: Postoperative till day 90
Patient-Centred Outcomes - Fatigue
- FACIT (Functional Assessment Of Chronic Illness Therapy)
Measured: Postoperative till day 90
Patient-Centred Outcomes - Depression
- Hospital Anxiety and Depression Scale (HADS)
Measured: Postoperative till day 90
Patient-Centred Outcomes - Patient Satisfaction
- Patient satisfaction score using visual analogue scale (0 - 10)
Measured: Postoperative till day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study start11 Jun 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CABGStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Recruited patients will be randomized 1:1 to either receive AKG or placebo, stratified to each institution. Following successful randomization, each patient will be assigned a unique patient study number and a unique medication kit number.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Wellcome Leap Inc.
- Responsible party
- Sponsor
- Investigators
- Lian Kah Ti, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07031128
- Sponsor's protocol ID
- 2023/00747
- Other IDs
- 2023
- Status last verified
- Sep 2024
- First submitted
- 16 Oct 2024
- Last updated
- 22 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07031128
- Acronym / sponsor ID
- 2023/00747
- Conditions
- CABG
- Keywords
- Geroprotector, Alpha-ketoglutarate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Collaborators
- Wellcome Leap Inc.
- Study start
- 11 Jun 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 22 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Within 24 hours of surgery, single-cell mass cytometry identified signalling changes in immune cell subsets that characterise the phenotypic and functional immune response to surgery. These signals accounted for 40-60% of observed patient variability, and strong correlations were found between these immune signatures with the speed of recovery from fatigue, pain, and functional impairment. In another study, Fragiadakis found that the preoperative immune state was also predictive of recovery from surgery, with toll-like receptor (TLR) 4 signalling in cluster of differentiation (CD) 14+ monocytes accounting for 50% of observed variance in clinical recovery. Furthermore, the group showed that patients undergoing an intermediate risk cardiac surgery had a significantly higher risk of developing multi-organ failure when their cytokine response profile was highly proinflammatory after stimulation with Escherichia coli-derived lipopolysaccharide . Another study showed that patients' immune response after surgery and immune profile before surgery predicted the development of surgical site complications in abdominal surgery. Taken together, these studies were consistent in suggesting that immune profiles play a major role in surgical resilience.
Therefore, it is postulated that giving a geroprotector in the perioperative period can mitigate the aging-related immune changes and prevent a dysfunctional surgical stress response, directly impacting surgical resilience. AKG is a geroprotector that benefits patients undergoing cardiac surgery. Plasma concentrations of AKG are reduced in patients with ischemic heart disease and it is possible that this aggravates myocardial ischemic injury during CABG. AKG supplementation during cardiopulmonary bypass significantly decreased ischaemic injury markers (creatine kinase MB and troponin T) by 30-50% in patients undergoing heart surgery, secondary to improved myocardial oxygen extraction.
AKG has beneficial effects beyond its cardiac effects. AKG is an intermediate in the Krebs cycle which is involved in various metabolic and cellular pathways as a signalling molecule, energy source, and precursor of amino acid synthesis. AKG is an anti-oxidative agent and a significant source of cellular adenosine triphosphate (ATP). Therefore, AKG plays an important role in multiple metabolic processes, and has been shown to preserve skeletal muscle, improve renal function, and protect neurological function. AKG is also a regulator of cell signalling pathways that maintain energy homeostasis, including mechanistic target of rapamycin (mTOR) and AMP-activated protein kinase (AMPK). By reducing the triggers of oxidative stress and hypoxia, AKG can moderate inflammation. AKG also has immune-modulatory properties. It modulates monocyte and neutrophil function by increasing phagocytosis and reactive oxygen species (ROS) intermediate production, macrophages by enhancing cytokine production, and lymphocytes by enhancing their proliferation.
Hypothesis Inflammaging and immunosenescence renders the older patient vulnerable to a dysfunctional surgical stress response.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Recruited patients will be randomized 1:1 to either receive AKG or placebo, stratified to each institution. Following successful randomization, each patient will be assigned a unique patient study number and a unique medication kit number.
| Arm | Type | Receives |
|---|---|---|
| AKG | Experimental | Dietary Supplement: Alpha-ketoglutarateTo receive AKG tablets (1g a day, once a day, taken orally) |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboTo receive placebo tablets (1g a day, once a day, taken orally) |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Scheduled for elective CABG with cardiopulmonary bypass
- Aged 50 years and above
- Adequate cognitive function to be able to give informed consent
Key exclusion criteria (10 listed)
- Patients already taking AKG as a supplement
- Substance abuse disorder either untreated or treated
- 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
- HIV/AIDS
- Patients undergoing or scheduled to undergo chemotherapy or any other treatment for malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alpha-ketoglutarateAlpha-ketoglutarate supplements | Dietary supplement | AKG |
| PlaceboPlacebo tablets | Dietary supplement | Placebo |
Primary outcome
Composite of systemic inflammatory response syndrome (SIRS) and at least 1 organ system
Time frame: Postoperative till day 90
The primary outcome will be a composite of systemic inflammatory response syndrome (SIRS) and at least 1 organ system dysfunction in the systems below. * SIRS; and * Cardiovascular dysfunction; and/or * Neurologic dysfunction; and or * Renal dysfunction; and/or * Respiratory dysfunction; and or * Coagulation dysfunction
19 secondary outcomes
Other Clinical Outcomes which may be impacted by AKG - Muscle Mass
Time frame: Postoperative till day 90
Other Clinical Outcomes which may be impacted by AKG - Muscle Strength
Time frame: Postoperative till day 90
Other Clinical Outcomes which may be impacted by AKG - Infections Acquired
Time frame: Postoperative till day 90
Other Clinical Outcomes which may be impacted by AKG - Long-term Outcomes
Time frame: Postoperative till day 90
Other Clinical Outcomes which may be impacted by AKG - Mortality
Time frame: Postoperative till day 90
Resource Utilization - Length of stay
Time frame: Postoperative till day 90
Resource Utilization - Discharge
Time frame: Postoperative till day 90
Resource Utilization - Unplanned readmission
Time frame: Postoperative till day 90
Resource Utilization - Hospital bill size
Time frame: Postoperative till day 90
Biological Ageing - Methylation & Dynamic Clocks
Time frame: Postoperative till day 90
Identification of Immune or Inflammatory Markers
Time frame: Postoperative till day 90
Investigations on Immune Reactivity's Relation with Surgical Resilience
Time frame: Postoperative till day 90
Patient-Centred Outcomes - Frailty
Time frame: Postoperative till day 90
Patient-Centred Outcomes - Pain
Time frame: Postoperative till day 90
Patient-Centred Outcomes - Disability
Time frame: Postoperative till day 90
Patient-Centred Outcomes - Quality of Life
Time frame: Postoperative till day 90
Patient-Centred Outcomes - Fatigue
Time frame: Postoperative till day 90
Patient-Centred Outcomes - Depression
Time frame: Postoperative till day 90
Patient-Centred Outcomes - Patient Satisfaction
Time frame: Postoperative till day 90
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2025.
- Individual participant dataSharing planned: No
Related trials for CABG
Not yet recruiting
Partial Cardiac Denervation for Preventing Atrial Fibrillation After CABG
Postoperative Atrial Fibrillation, Coronary Artery Disease
Active, not recruiting
Investigation of the Effects of Respiratory Muscle Training Combined With Otago Exercises in Elderly Patients Undergoing Coronary Artery Bypass Graft Surgery
Coronary Artery Bypass Graft (CABG)
Recruiting
Postural Mobilization Compared to Noradrenaline Only in Off-Pump CABG Surgery
Coronary Artery Disease With Need for Bypass Surgery, Coronary Artery Disease(CAD)
Active, not recruitingPhase 1
Comparison of Analgesic Efficacy Between Ultrasound Guided Serratus Anterior Plane Block or Thoracic Paravertebral Block Versus Intravenous Fentanyl for On-pump Coronary Artery Bypass Graft Surgery
Intra and Post Operative Pain Management, Fast Track Program,(Enhanced Recovery After Surgery (ERAS))
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lian Kah Ti principal investigator
National University Hospital, Singapore
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Alpha-ketoglutarate in people with CABG, run by National University Hospital, Singapore at 2 sites in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lian Kah Ti (6567724200, anatilk@nus.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of systemic inflammatory response syndrome (SIRS) and at least 1 organ system (time frame: Postoperative till day 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2025.