Status:
RECRUITING
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.
Lead Sponsor:
Queen Mary University of London
Conditions:
Coronary Artery Bypass
Coronary Artery Bypass Graft
Eligibility:
All Genders
18-90 years
Phase:
NA
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 en...
Detailed Description
Summary of the study design and methodology The research nurse or doctor will meet with the patient to explain the study and check the following: Pre-screening: The research nurse, who may also be p...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06602336
Start Date
May 20 2025
End Date
May 1 2026
Last Update
January 7 2026
Active Locations (1)
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1
Barts Health
London, United Kingdom