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.

NCT06602336 | Recruiting DMC

• 1 other identifier: 346076
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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 ensure accuracy. If successful, this device could reduce the need for frequent blood tests during surgery recovery, making patients more comfortable. It might also be useful in emergency rooms for quick diagnoses, especially for patients with chest pain. This study will take place at Barts Hospital with patients having planned coronary artery bypass graft (CABG) and/or replacement valve surgery. Participants will wear the sensors on their upper arm, during which the sensors will continuously measure lactate levels. Participants will also have hourly blood samples taken. In the future, the data from this new device will be used to train computer algorithms to provide quick responses that help manage a patient\'s condition, improving future medical care and technology.

Conditions

Coronary Artery Bypass; Coronary Artery Bypass Graft; Coronary Artery Bypass Graft Surgery (CABG); Valve Replacement; Valve Surgery; Cardiovascular; CABG

Keywords

device; cardiovascular; coronary artery bypass surgery; replacement valve surgery; Continuous lactate monitor; CABG; wearable device

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 the electrical signal from the continuous interstitial fluid lactate measurements and laboratory lactate measurements. Evaluate the change in interstitial fluid lactate measurements via a surrogate output of change in current (nA; using an investigational device by Abbott Diabetes Care Ltd.) to local Radiometer ABL 90 venous and arterial blood gas lactate measurements 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 the electrical signal from the continuous interstitial fluid lactate measurements and venous laboratory measurements of high-sensitivity troponin-T. Evaluate the relationship between the current (nA) output of a continuous interstitial fluid lactate monitor (using an investigational device by Abbott Diabetes Care 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 (4)

• Relationship between arterial and venous lactate measurements

  14 hours

• Relationship between arterial and venous lactate and venous troponin measurements

  14 hours

• Functionality of the device for up to 48 hours post-surgery.

  48 hours

• Evaluate safety of lactate sensor

  Up to 8 days

Study Arms (1)

Investigational Lactate Device

EXPERIMENTAL

Continuous interstitial fluid lactate monitoring using the Abbott Investigational Lactate Device

Device: Continuous Lactate Monitoring Device

Interventions

Continuous Lactate Monitoring Device DEVICE

Continuous interstitial fluid lactate monitoring using the Abbott Investigational Lactate Device.

Investigational Lactate Device

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) and/or 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 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

Sponsors & Collaborators

• Queen Mary University of London: lead

Study Sites (1)

Barts Health

London, United Kingdom

RECRUITING

Study Officials

• Prof Anthony Mathur

  Queen Mary University of London

  STUDY CHAIR

Central Study Contacts

Prof Anthony Mathur

CONTACT

02037658740; a.mathur@qmul.ac.uk

Emily Kirkpatrick

CONTACT

e.kirkpatrick@qmul.ac.uk

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: September 16, 2024
• First Posted: September 19, 2024
• Study Start: May 20, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: January 7, 2026

Record last verified: 2026-01

Locations

GB (1)