At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- Mix of remote tasks and in-person visits
- Drug or intervention
- Continuous Lactate Monitoring Device (device)
- How long the study runs
- Study runs about 20 months (dates as stated)
- About the drug or intervention
- Continuous Lactate Monitoring Device — device: Continuous interstitial fluid lactate monitoring using the Abbott Investigational Lactate Device.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years to 90 Years
- Who
- All
- Number of participants
- 61
- Started
- 2025-05-20
- Last checked
- 2026-06
Plain English Summary
What is this study?
- • Testing a new treatment for coronary artery bypass
- • NA - 61 participants
- • The main goal of this study is to see if a wearable device can reliably track changes in lactate levels in the body
Who can take part?
- • Ages 18 Years to 90 Years
- • Diagnosed with coronary artery bypass
Where?
- • London - Barts Health
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
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 patient\'s direct care team, will look at the records for patients who are attending St Bartholomew's hospital for cardiac surgery for grafts and/or valve replacement. Informed Consent: If the patient is eligible, and would like to take part in the study, the research nurse or doctor will ask the patient to sign a consent form indicating their willingness to participate in the study. 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. Sensor Application: Up to 5 days pre-surgery, the research nurse will place two lactate sensors on the patient's arm. The sensor has a 24 hour warm-up period prior to continuously measuring the patient's lactate levels. 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 valve surgery. CABG and/or replacement valve surgery: The patient will then undergo their planned CABG and/or replacement valve surgery as usual. 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. Sensor Removal: Up to 48 hours post-surgery, the sensors 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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 90 Years
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓Able and willing to give agreement to take part
- ✓≥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...
- ✓Absence of the following complications:
Who cannot take part
- ✗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 kidney 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)
See the full criteria
Where Is This Study? (1 UK site)
Barts Health
London, United Kingdom