Status:
NOT_YET_RECRUITING
A Single-centre Study Comparing a Non-invasive Lactate Sensor to Standard Invasive Measurements in Patients Undergoing Coronary Artery Bypass Surgery.
Lead Sponsor:
Queen Mary University of London
Conditions:
Cardiovascular
Coronary Artery Bypass
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
The main goal of this study is to see how well a non-invasive lactate sensor measures lactate levels compared to standard blood tests. This might reduce the need for frequent blood draws during surger...
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) +/- 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 consent date)
- Heart failure with EF \<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 within 6 months of planned consent date)
- Severe anaemia (\<10 recorded within 6 months of planned consent date)
- 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 (\<35 g/L recorded within 6 months of consent date)
- Those lacking capacity to consent or are deemed vulnerable adults
- Unable to speak English
Key Trial Info
Start Date :
December 2 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06597253
Start Date
December 2 2025
End Date
July 31 2026
Last Update
March 10 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Barts Health
London, United Kingdom