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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
Led by Queen Mary University of London · Updated on 2026-01-07
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a wearable device designed to continuously monitor lactate levels in the body for patients undergoing planned coronary artery bypass graft (CABG) and/or valve replacement surgery. The goal is to compare the device's readings with standard blood tests to verify accuracy. If successful, this device could reduce the need for frequent blood tests during surgery recovery and may also help in emergency rooms, especially for patients with chest pain. The study is conducted at Barts Hospital and sponsored by Queen Mary University of London. Participants will have two lactate sensors placed on their upper arm up to five days before surgery, with a 24-hour warm-up period before continuous measurement begins. During and after surgery, the sensors will monitor lactate levels for up to 48 hours. Hourly blood samples will be taken for up to 14 hours during surgery to compare with the sensor readings, including measurements of arterial and venous lactate, as well as venous troponin. Vital signs such as blood pressure, heart rate, and respiratory rate will be monitored regularly, and any medication changes will be recorded. Participants will undergo assessments including ECGs, blood pressure, heart rate, respiratory rate, and blood tests both before and after surgery. The sensors will be removed within 48 hours post-surgery, and the skin will be checked for any reactions. Follow-up monitoring will continue for up to 24 hours after sensor removal or until hospital discharge. Researchers will evaluate the device's accuracy, functionality, and safety through continuous lactate sensor measurements compared to standard blood tests over 14 to 48 hours, and safety monitoring up to 8 days.
CONDITIONS
Brief Title
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.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able and willing to give informed consent
- Age 18 to 90 years
- Scheduled for successful coronary artery bypass grafting and/or valve replacement surgery
- No significant bleeding requiring reoperation
- No major life-changing stroke
You will not qualify if you...
- Previous coronary artery bypass graft surgery
- Recent acute coronary syndrome within 4 weeks
- Heart failure with ejection fraction less than 35%
- Chronic severe renal failure with eGFR less than 30 mL/min/1.73m2
- Severe anaemia with hemoglobin less than 10
- Known or suspected allergies to medical grade silicone adhesives
- Pre-existing skin conditions on upper arm where device is applied
- Implanted medical devices such as pacemakers
- Severe liver cirrhosis stage III or higher
- Lymphoedema or pitting oedema at time of consent
- Pregnancy
- History of ongoing malignant disease
- Hypoalbuminaemia less than 35 g/L
- Lack of capacity to consent or vulnerable adult status
- Unable to speak English
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for screening and enrollment
Duration - Up to 5 days pre-surgery
Participants will have two lactate sensors placed on their arm up to 5 days before surgery to continuously measure lactate levels after a 24-hour warm-up period.
1 visit (in-person) for sensor placement
Duration - Day of surgery admission
Participants will provide medical history, have vital signs measured, undergo an ECG, and provide baseline blood samples as part of standard pre-surgery care.
1 visit (in-person)
Duration - Surgery day and immediate post-operative period
Participants will undergo their planned coronary artery bypass graft and/or valve replacement surgery as usual.
1 surgical procedure
Duration - Up to 14 hours post-surgery
Participants will have hourly blood samples taken through surgical tubes for up to 14 hours, with hourly measurements of vital signs and medication monitoring, to compare standard lactate measurements with sensor data.
Continuous monitoring and hourly blood sampling
Duration - Up to 48 hours post-surgery
Up to 48 hours after surgery, the lactate sensors will be removed, and participants will have skin checks, vital signs measured, and ECGs performed while medication changes are noted.
1 to 2 visits for sensor removal and assessments
Duration - Up to 24 hours after sensor removal or until discharge
Participants will be monitored for up to 24 hours after sensor removal or until hospital discharge, with ongoing vital sign measurements, ECGs, and medication monitoring.
1 to 2 visits depending on hospital stay length
Trial Site Locations
Total: 1 location
1
Barts Health
London, United Kingdom
Actively Recruiting
Research Team
P
Prof Anthony Mathur
E
Emily Kirkpatrick
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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