- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02855671
Infrared Imaging in Septic Illness
The Application of Infrared Thermal Imaging in the Diagnosis and Prognostication of Septic Illness in Adults
The application of infrared thermal imaging in the diagnosis and prognostication of septic illness in adults.
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Leicestershire
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Leicester, Leicestershire, Reino Unido, LE1 5WW
- University Hospitals of Leicester
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Male or Female, aged 18 years or above.
- Healthy volunteers - free from acute illness; will include staff and students at the University of Leicester and UHL, and patient relatives.
- 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).
- Able (in the Investigators opinion) and willing to comply with all study requirements.
Exclusion Criteria:
- Patient refusal
- Inability to gain appropriate assent/consent
- Children
- Prisoners or in police custody
- Skin marking likely to preclude image analysis (such as extensive tattoos).
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Grupo
- Perspectivas temporales: Futuro
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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Voluntarios sanos
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Patients in all groups will undergo infrared thermal imaging of the face and anterior leg (centered on the knee)
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Septicemia
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Patients in all groups will undergo infrared thermal imaging of the face and anterior leg (centered on the knee)
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Severe sepsis/septic shock
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Patients in all groups will undergo infrared thermal imaging of the face and anterior leg (centered on the knee)
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Measure the extent of thermally apparent mottling of the anterior knee using a previously described mottling score.
Periodo de tiempo: 18 months
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Measure the extent of mottling (graded from 1 to 5) using the mottling score described by Ait-Oufella et al.
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18 months
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Measure core-peripheral temperature difference by means of a facial thermal image (Thermal Core-Peripheral Temperature Difference - TCPTD).
Periodo de tiempo: 18 months
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Thermal core-peripheral temperature difference (TCPTD) will be assessed using temperature at the medial canthus (core) and nasal (peripheral) in degrees centigrade.
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18 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Association between the severity of thermally derived mottling score and the Sequential Organ Failure Assessment (SOFA) score.
Periodo de tiempo: 18 months
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Association between mottling score (graded 1-5) and illness severity as determined by the SOFA score (0-24).
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18 months
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Association between the severity of thermally derived mottling score and the APACHE II score.
Periodo de tiempo: 18 months
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Association between mottling score (1-5) and illness severity as determined by the APACHE II score (0-71).
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18 months
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Association between the extent of Thermal Core Peripheral Temperature Difference (TCPTD) and the SOFA score.
Periodo de tiempo: 18 months
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Associations between TCPTD (degrees centigrade) and illness severity as determined by the SOFA score (0-24).
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18 months
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Association between the extent of Thermal Core Peripheral Temperature Difference (TCPTD) and the APACHE II score.
Periodo de tiempo: 18 months
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Associations between TCPTD (degrees centigrade) and illness severity as determined by the APACHE II score (0-71).
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18 months
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Mortality at 30 days and 1 year from the point of enrollment.
Periodo de tiempo: 18 months
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Mortality information will be collected at 30 days and 1 year from the point of patient enrollment (0-6 months) and correlated to the thermally derived mottling score and thermal core-peripheral temperature difference to assess for potential prognostic value of the above investigations.
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18 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Jonathan Thompson, MB ChB, BSc, MD, University Hospitals, Leicester
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- UHL 11486
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Septicemia
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University of Kansas Medical CenterUniversity of KansasReclutamientoSepticemia | Shock séptico | Síndrome de sepsis | Sepsis, Severa | Sepsis bacteriana | Sepsis BacteriemiaEstados Unidos
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Jip GroenInBiomeReclutamientoColonización Microbiana | Infeccion Neonatal | Sepsis Neonatal, Inicio Temprano | Enfermedad microbiana | Sepsis clínica | Sepsis neonatal con cultivo negativo | Sepsis Neonatal, Inicio Tardío | Sepsis neonatal con cultivo positivoPaíses Bajos
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Indonesia UniversityTerminadoImpacto del tratamiento con heparina no fraccionada en dosis bajas sobre la inflamación en la sepsisSepsis severa con shock séptico | Sepsis severa sin shock sépticoIndonesia
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Ohio State UniversityTerminadoSepsis, Sepsis Severa y Shock SépticoEstados Unidos
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Yale UniversityRetiradoSepsis Neonatal de Inicio Temprano | Sepsis neonatal de inicio tardíoEstados Unidos
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The University of QueenslandRoyal Brisbane and Women's HospitalDesconocido
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University of LeicesterUniversity Hospitals, Leicester; The Royal College of AnaesthetistsTerminadoSepticemia | Shock séptico | Sepsis severa | Síndrome de sepsisReino Unido
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Weill Medical College of Cornell UniversityNational Heart, Lung, and Blood Institute (NHLBI); New York Presbyterian Hospital y otros colaboradoresTerminadoSepticemia | Shock séptico | Sepsis severa | Infección | Síndrome de sepsisEstados Unidos
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Inverness Medical InnovationsTerminadoSepticemia | Síndrome de Respuesta Inflamatoria Sistémica | Sepsis severa | Síndrome de sepsisEstados Unidos
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Karolinska InstitutetÖrebro University, SwedenTerminadoSepticemia | Síndrome de sepsis | Sepsis, SeveraSuecia
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