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.

Launched by QUEEN MARY UNIVERSITY OF LONDON · Sep 16, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a new wearable device that can continuously measure lactate levels in the body for patients undergoing heart surgeries, like coronary artery bypass grafting (CABG) or valve replacement. Lactate levels can help doctors understand how well a patient is recovering after surgery. The goal is to see if this device can provide accurate readings compared to regular blood tests, which could mean fewer needle sticks for patients during recovery. If successful, this technology may also help doctors make quicker decisions in emergency situations, especially for patients experiencing chest pain.

To be part of this study, participants need to be between 18 and 90 years old and able to give consent. They should be scheduled for planned heart surgery and have no serious complications that could affect their surgery outcome. During the trial, participants will wear a sensor on their upper arm that constantly tracks lactate levels while also having blood samples taken every hour. This study is taking place at Barts Hospital, and while it is not yet recruiting, it aims to improve patient care and technology in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 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