A Single Centre Study Comparing Continuous Interstitial Fluid Lactate Detection (as Measured by Change in Current) to Standard Measurements of Change in Venous and Arterial Lactate in Patients Undergoing Elective Coronary Artery Bypass Graft Surgery and/or Valve Replacement.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- Continuous lactate sensor measurement compared venous and arterial blood gas lactate measurements.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Investigational Lactate Device
Continuous interstitial fluid lactate monitoring using the Abbott Investigational Lactate Device
干预措施: Continuous Lactate Monitoring Device (Device)
结局指标
主要结局
Continuous lactate sensor measurement compared venous and arterial blood gas lactate measurements.
时间窗: 14 hours
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.
Continuous lactate sensor measurement compared Troponin-T
时间窗: 14 hours
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.
次要结局
- 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)