CardiovascularCONTINUUM LNCT06597253
A Single-centre Study Comparing a Non-invasive Lactate Sensor to Standard Invasive Measurements in Patients Undergoing Coronary Artery Bypass Surgery.
A study testing Lactate sensor in people with Cardiovascular and Coronary Artery Bypass, run by Queen Mary University of London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cardiovascular, Coronary Artery Bypass, Valve Replacement
- What is being tested?
- Lactate sensor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Feb 2025to 25 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Centre Study Comparing a Continuous Non-invasive Lactate Sensor Measurement to Standard Invasive Measurements of Venous and Arterial Lactate in Patients Undergoing Elective Coronary Artery Bypass Graft +/- Valve Surgery.
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.
Read more
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.
Read the 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 part of the patients direct care team will look at the records for patients who are attending St Bartholomews hospital for cardiac surgery for grafts and or valve replacement.
Informed Consent: If the patient is eligible and wishes to participate in the study, a qualified individual from the research team will obtain their consent. If the person obtaining the consent is not a doctor, the participant will be given the opportunity to discuss the study with a medically qualified individual.
Screening: The research nurse or doctor will collect demographic information from the patient and ensure the patient meets the study's inclusion and exclusion criteria.
Pre-Surgery Admission: The research nurse will gather details about the patient's medical history and current medications. The patient will have their blood pressure, heart rate, respiratory rate, weight, and height measured, and an ECG performed. Baseline blood samples will be collected as per the standard of care pre-CABG and/ or replacement valve surgery. If the patient agrees to additional blood samples, they will also have samples collected for sex hormone levels.
CABG +/- replacement valve surgery: The patient will then undergo their planned coronary artery bypass graft (CABG) +/- replacement valve surgery as usual.
Sensor Application: After surgery when the patient is settled in Cardiac Intensive Care Unit, the research nurse will place a lactate sensor on the patient's arm. This sensor will continuously measure the patient's lactate levels. The patient may be asleep whilst the sensor is attached.
Blood Sampling: The patient will have hourly blood samples taken through the tubes inserted for their surgery for up to 14 hours to compare with the sensor readings. These samples will include 12 arterial lactate, 12 central venous lactate, and 12 venous troponin samples. Hourly measurements of the patient's blood pressure, heart rate, and respiratory rate will be taken, and any medication changes will be noted. If the patient agrees to additional blood samples, they will also have 6 samples collected for inflammatory profiles and 3 for full blood counts.
Sensor Removal: After 14 hours, the sensor will be removed, and the patient's skin will be checked for any changes, like a rash. The patient will also have their blood pressure, heart rate, and respiratory rate measured, and an ECG performed. Any changes to the patient's medication will be noted.
Follow-Up: The study team will monitor the patient for up to 24 hours after the sensor is removed or until the patient is discharged from the hospital (whichever is earlier). The study team will note any medication changes, measure the patient's blood pressure, heart rate, and respiratory rate, and perform an ECG.
- Conditions
- Cardiovascular, Coronary Artery Bypass, Valve Replacement
- Being tested
- Lactate sensor
- Keywords
- device, coronary artery bypass surgery, lactate, sensor, valve replacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactate sensorDevice
Continuous interstitial fluid lactate monitoring using the non-invasive Nemaura Investigational Lactate Device.
| Study group | Role | What they receive |
|---|---|---|
| Lactate Sensor Device Arm | Experimental | Continuous interstitial fluid lactate monitoring using the non-invasive Nemaura Investigational Lactate Device. Receives: Device: Lactate sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 14 hours
Secondary outcomes (3)
Relationship between arterial and venous lactate measurements
Correlation coefficients describing the strength of association between arterial and central venous lactate measurements. Up to 12 samples will be taken and compared within a 14-hour period post elective CABG +/- valve replacement surgery.
Measured: 14 hours
Evaluate safety of lactate sensor
Number of patients experiencing adverse reactions or serious adverse reactions to the non-invasive lactate sensor up to 24 hours post application of the device as measured by number of device-related adverse events.
Measured: 24 hours
Relationship between arterial and venous lactate and venous troponin measurements
Correlation coefficients describing the strength of association between arterial/ central venous lactate and venous troponin measurements. Samples taken hourly up to 12 samples within a 14-hour period post-elective CABG +/- valve replacement surgery.
Measured: 14 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start14 Feb 2025
- Primary completion25 Nov 2025
- Study completion25 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CardiovascularStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Prof Anthony Mathur, Study chair, Queen Mary University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06597253
- Sponsor's protocol ID
- 340203
- Acronym
- CONTINUUM L
- Status last verified
- Feb 2026
- First submitted
- 30 Aug 2024
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Centre Study Comparing a Continuous Non-invasive Lactate Sensor Measurement to Standard Invasive Measurements of Venous and Arterial Lactate in Patients Undergoing Elective Coronary Artery Bypass Graft +/- Valve Surgery.
- ClinicalTrials.gov ID
- NCT06597253
- Acronym / sponsor ID
- CONTINUUM L / 340203
- Conditions
- Cardiovascular, Coronary Artery Bypass, Valve Replacement
- Keywords
- device, coronary artery bypass surgery, lactate, sensor, valve replacement
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Study start
- 14 Feb 2025 (actual)
- Primary completion
- 25 Nov 2025 (actual)
- Study completion
- 25 Nov 2026 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 part of the patients direct care team will look at the records for patients who are attending St Bartholomews hospital for cardiac surgery for grafts and or valve replacement.
Informed Consent: If the patient is eligible and wishes to participate in the study, a qualified individual from the research team will obtain their consent. If the person obtaining the consent is not a doctor, the participant will be given the opportunity to discuss the study with a medically qualified individual.
Screening: The research nurse or doctor will collect demographic information from the patient and ensure the patient meets the study's inclusion and exclusion criteria.
Pre-Surgery Admission: The research nurse will gather details about the patient's medical history and current medications. The patient will have their blood pressure, heart rate, respiratory rate, weight, and height measured, and an ECG performed. Baseline blood samples will be collected as per the standard of care pre-CABG and/ or replacement valve surgery. If the patient agrees to additional blood samples, they will also have samples collected for sex hormone levels.
CABG +/- replacement valve surgery: The patient will then undergo their planned coronary artery bypass graft (CABG) +/- replacement valve surgery as usual.
Sensor Application: After surgery when the patient is settled in Cardiac Intensive Care Unit, the research nurse will place a lactate sensor on the patient's arm. This sensor will continuously measure the patient's lactate levels. The patient may be asleep whilst the sensor is attached.
Blood Sampling: The patient will have hourly blood samples taken through the tubes inserted for their surgery for up to 14 hours to compare with the sensor readings. These samples will include 12 arterial lactate, 12 central venous lactate, and 12 venous troponin samples. Hourly measurements of the patient's blood pressure, heart rate, and respiratory rate will be taken, and any medication changes will be noted. If the patient agrees to additional blood samples, they will also have 6 samples collected for inflammatory profiles and 3 for full blood counts.
Sensor Removal: After 14 hours, the sensor will be removed, and the patient's skin will be checked for any changes, like a rash. The patient will also have their blood pressure, heart rate, and respiratory rate measured, and an ECG performed. Any changes to the patient's medication will be noted.
Follow-Up: The study team will monitor the patient for up to 24 hours after the sensor is removed or until the patient is discharged from the hospital (whichever is earlier). The study team will note any medication changes, measure the patient's blood pressure, heart rate, and respiratory rate, and perform an ECG.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lactate Sensor Device Arm | Experimental | Device: Lactate sensorContinuous interstitial fluid lactate monitoring using the non-invasive Nemaura Investigational Lactate Device. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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):
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactate sensorContinuous interstitial fluid lactate monitoring using the non-invasive Nemaura Investigational Lactate Device. | Device | Lactate Sensor Device Arm |
Primary outcome
Continuous lactate sensor measurement compared venous and arterial blood gas lactate measurements.
Time frame: 14 hours
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.
Continuous lactate sensor measurement compared Troponin-T
Time frame: 14 hours
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.
3 secondary outcomes
Relationship between arterial and venous lactate measurements
Time frame: 14 hours
Evaluate safety of lactate sensor
Time frame: 24 hours
Relationship between arterial and venous lactate and venous troponin measurements
Time frame: 14 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof Anthony Mathur study chair
Queen Mary University of London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactate sensor in people with Cardiovascular and Coronary Artery Bypass, run by Queen Mary University of London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Continuous lactate sensor measurement compared venous and arterial blood gas lactate measurements. (time frame: 14 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.