Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
112 participants
OBSERVATIONAL
2016-07-31
2019-02-01
Brief Summary
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During times of severe infection (sepsis), the small blood vessels supplying oxygen and nutrients to the skin and other organs (called the microcirculation), become abnormal and do not function as they normally would in health. Monitoring these small blood vessels is difficult to do clinically and the investigators want to investigate a new way of doing this.
The aim of this study is to validate a novel method of assessing the function of the microcirculation in healthy volunteers and patients with sepsis, by measuring the skin temperature profile of the leg and face with a thermal imaging camera. Thermal imaging cameras measure the heat given off by all objects and represents this as a picture, with colour used to represent the different temperatures.
Patients will be recruited from the Emergency Department and Intensive Care Units at University Hospitals of Leicester in to one of two groups based on their illness severity; uncomplicated sepsis and severe sepsis. Healthy volunteers will be recruited in to a third group. Recruitment will take place over a 6-month period with follow-up lasting for 12-months following recruitment. 105 participants will be recruited in total.
Temperature patterns seen on the face and leg will be investigated between the different groups. Changes in these temperature patterns as patients recover from sepsis (or indeed become worse), will also be investigated. Information from the thermal images will be correlated to routinely measured markers of infection, including clinical measurements (blood pressure, pulse, etc) and routine blood investigations.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Healthy volunteers
Infrared thermal imaging
Patients in all groups will undergo infrared thermal imaging of the face and anterior leg (centered on the knee)
Sepsis
Infrared thermal imaging
Patients in all groups will undergo infrared thermal imaging of the face and anterior leg (centered on the knee)
Severe sepsis/septic shock
Infrared thermal imaging
Patients in all groups will undergo infrared thermal imaging of the face and anterior leg (centered on the knee)
Interventions
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Infrared thermal imaging
Patients in all groups will undergo infrared thermal imaging of the face and anterior leg (centered on the knee)
Eligibility Criteria
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Inclusion Criteria
2. Healthy volunteers - free from acute illness; will include staff and students at the University of Leicester and UHL, and patient relatives.
3. Patient with septic illness will be recruited in to one of two groups depending on their disease severity - Sepsis (without evidence of organ dysfunction) or severe sepsis (with organ dysfunction).
4. Able (in the Investigators opinion) and willing to comply with all study requirements.
Exclusion Criteria
2. Inability to gain appropriate assent/consent
3. Children
4. Prisoners or in police custody
5. Skin marking likely to preclude image analysis (such as extensive tattoos).
18 Years
ALL
Yes
Sponsors
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Association of Anaesthetists of Great Britain and Ireland
UNKNOWN
University Hospitals, Leicester
OTHER
Responsible Party
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Principal Investigators
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Jonathan Thompson, MB ChB, BSc, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospitals, Leicester
Locations
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University Hospitals of Leicester
Leicester, Leicestershire, United Kingdom
Countries
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Other Identifiers
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UHL 11486
Identifier Type: -
Identifier Source: org_study_id
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