Continuous wearable lactate monitoring during elective coronary bypass or valve replacement
A Single Centre Study Comparing Continuous Interstitial Fluid Lactate Detection (as Measured by Change in Current) to Standard Measurements of Change in Venous and Arterial Lactate in Patients Undergoing Elective Coronary Artery Bypass Graft Surgery and/or Valve Replacement.
We will test whether a wearable sensor can continuously track lactate levels in adults having planned coronary artery bypass or valve replacement surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Queen Mary University of London Academic / other |
| Locations | 1 site (London) |
| Trial ID | NCT06602336 on ClinicalTrials.gov |
What this trial studies
This single-centre interventional study will place two wearable interstitial lactate sensors on patients' upper arms up to five days before elective coronary artery bypass graft (CABG) and/or valve replacement surgery. The sensors have a 24-hour warm-up period and will continuously record lactate levels while hourly blood samples are collected during the perioperative period to compare readings. Clinical data including vital signs, ECG, and routine laboratory lactate measurements will be recorded for comparison with sensor data. Collected device data may also be used to help train algorithms for faster lactate interpretation in future clinical settings.
Who should consider this trial
Good fit: Adults aged 18–90 scheduled for elective CABG and/or valve replacement who can give informed consent and meet the study's inclusion and operative success criteria are eligible.
Not a fit: Patients with prior CABG, recent acute coronary syndrome, severe heart failure (EF <35%), chronic severe renal failure (eGFR <30), severe anaemia (Hb <10), or adhesive allergies may not benefit or are excluded.
Why it matters
Potential benefit: If successful, the device could reduce the need for frequent blood draws after surgery and enable earlier detection of metabolic deterioration.
How similar studies have performed: Continuous interstitial lactate monitoring is a relatively new approach with limited clinical data to date, although continuous metabolic sensing has shown promise in other settings.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
London
- Barts Health — London, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Prof Anthony Mathur
- Email: a.mathur@qmul.ac.uk
- Phone: 02037658740
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.