NCT06602336 A Single Centre Study Comparing Continuous Interstitial Fluid Lactate Detection to Standard Measurements of Lactate in Patients Undergoing Elective Coronary Artery Bypass Graft Surgery and/or Valve Replacement.
| NCT ID | NCT06602336 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Queen Mary University of London |
| Condition | Coronary Artery Bypass |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-05-20 |
| Primary Completion | 2026-05-01 |
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.
This trial targets 50 participants in total. It began in 2025-05-20 with a primary completion date of 2026-05-01.
⚠ 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
The main goal of this study is to see if a wearable device can reliably track changes in lactate levels in the body. We\'ll compare the device\'s readings to standard blood tests to ensure accuracy. If successful, this device could reduce the need for frequent blood tests during surgery recovery, making patients more comfortable. It might also be useful in emergency rooms for quick diagnoses, especially for patients with chest pain. This study will take place at Barts Hospital with patients having planned coronary artery bypass graft (CABG) and/or replacement valve surgery. Participants will wear the sensors on their upper arm, during which the sensors will continuously measure lactate levels. Participants will also have hourly blood samples taken. In the future, the data from this new device will be used to train computer algorithms to provide quick responses that help manage a patient\'s condition, improving future medical care and technology.
Eligibility Criteria
Inclusion Criteria: * Able and willing to give informed consent * ≥18 to ≤ 90 years old * Successful surgery as defined by the below criteria (which will be recorded in the eCRF): * Operative Success: The successful completion of coronary artery bypass grafting (CABG) and/or valve insertion with grafts and/or valves * Absence of the following complications: * Significant bleeding requiring reoperation * Evidence of major life-changing stroke Exclusion Criteria: * Previous coronary artery bypass grafting * Recent acute coronary syndrome (within 4 weeks of planned consent date) * Heart failure with EF less than 35% (from TTE or CT from past 6 months - if both available lower value will be used). * Chronic severe renal failure (estimated eGFR less than 30 mL/min/1.73m2 by the MDRD formula recorded at time of consent) * Severe anaemia (Hb less than 10 recorded at time of consent) * Known or suspected allergies to medical grade silicone adhesives * Pre-existing skin condition on the upper arm where the device would be applied, including recent burns/ scalds, open wounds or clinically significant skin lesions. * Patients with implanted medical devices such as pacemakers or other CLMs * Severe liver cirrhosis (≥ stage III) * Lymphoedema or pitting oedema at the time of consent * Pregnancy * History of ongoing malignant disease * Hypoalbuminaemia (less than 35 g/L recorded at time of consent) * Those lacking capacity to consent or are deemed vulnerable adults * Unable to speak English
Contact & Investigator
Prof Anthony Mathur
STUDY CHAIR
Queen Mary University of London
Frequently Asked Questions
Who can join the NCT06602336 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Coronary Artery Bypass. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06602336 currently recruiting?
Yes, NCT06602336 is actively recruiting participants. Contact the research team at a.mathur@qmul.ac.uk for enrollment information.
Where is the NCT06602336 trial being conducted?
This trial is being conducted at London, United Kingdom.
Who is sponsoring the NCT06602336 clinical trial?
NCT06602336 is sponsored by Queen Mary University of London. The principal investigator is Prof Anthony Mathur at Queen Mary University of London. The trial plans to enroll 50 participants.