A Single-centre Study Comparing a Non-invasive Lactate Sensor to Standard Invasive Measurements in Patients Undergoing Coronary Artery Bypass Surgery.

NCT06597253 | Active Not Recruiting DMC

• 1 other identifier: 340203
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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 surgery recovery, and also provide a more comfortable experience for patients. This will also give us information regarding the suitability of the lactate sensor for monitoring other patients - for instance people attending the accident and emergency department with chest pain in which lactate levels may help make a quick diagnosis. Patients will be approached for this study if they are undergoing routine coronary artery bypass surgery (CABG) or valve replacement surgery. Participants will wear the non-invasive lactate sensor for up to 14 hours, and the readings will be correlated to lactate levels in blood samples. Once the sensor has been removed and the participant has been discharged from their elective surgery admission, the participant has completed the study. Participation in this study and the data collected from the sensor will help us understand how well it works and how it can be used to improve patient care in the future. In the future, the data from this new device will be used to train computer algorithms to provide quick responses that could help manage a patients condition, improving future medical care.

Conditions

Cardiovascular; Valve Replacement; Coronary Artery Bypass

Keywords

device; coronary artery bypass surgery; lactate; sensor; valve replacement

Outcome Measures

Primary Outcomes (2)

• Continuous lactate sensor measurement compared venous and arterial blood gas lactate measurements.

  Correlation coefficients describing the strength of association between a non-invasive continuous lactate sensor measurement (using a commercially developed investigational device by Nemaura Pharma Ltd) and local Radiometer ABL 90, venous and arterial blood gas lactate measurements (both absolute and change) measured hourly up to 12 samples within a 14-hour period post-elective CABG +/- valve replacement surgery.

  14 hours

• Continuous lactate sensor measurement compared Troponin-T

  Correlation coefficients describing the strength of association between a non-invasive continuous lactate sensor measurement (using a commercially developed investigational device by Nemaura Pharma Ltd) and venous laboratory measurements of high-sensitivity troponin-T measured hourly up to 12 samples within a 14-hour period post-elective CABG +/- valve replacement surgery.

  14 hours

Secondary Outcomes (3)

• Relationship between arterial and venous lactate measurements

  14 hours

• Evaluate safety of lactate sensor

  24 hours

• Relationship between arterial and venous lactate and venous troponin measurements

  14 hours

Other Outcomes (2)

• Exploration of relationship between lactate and inflammatory profiles.

  14 hours

• Exploration of relationship between lactate and sex hormone levels.

  14 hours

Study Arms (1)

Lactate Sensor Device Arm

EXPERIMENTAL

Continuous interstitial fluid lactate monitoring using the non-invasive Nemaura Investigational Lactate Device.

Device: Lactate sensor

Interventions

Lactate sensor DEVICE

Continuous interstitial fluid lactate monitoring using the non-invasive Nemaura Investigational Lactate Device.

Lactate Sensor Device Arm

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Queen Mary University of London: lead

Study Sites (1)

Barts Health

London, United Kingdom

Location

Study Officials

• Prof Anthony Mathur

  Queen Mary University of London

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2024
• First Posted: September 19, 2024
• Study Start: February 14, 2025
• Primary Completion: November 25, 2025
• Study Completion (Estimated): November 25, 2026
• Last Updated: February 18, 2026

Record last verified: 2026-02

Locations

GB (1)