Estudio de la presión intersticial subcutánea durante la sepsis (PISEP)
The pathophysiology of sepsis is characterized by the sudden onset of vasodilation and vascular permeability with capillary leakage. This leakage contributes to the development of generalized edema which is not clinically detectable below 4 litres but which becomes visible after a few days. The edema accumulates mainly at the subcutaneous level due to the high compliance of this tissue. Edema, and therefore hydrosodium overload, testifies to the severity of the inflammation. However, it could also be harmful in itself (affecting microcirculation and increasing mortality) as suggested by numerous clinical and experimental studies.
The transfer of fluids between vascular and interstitial compartments during sepsis therefore has a central role in the pathophysiology of the disease and associated mortality. These transfers are mainly controlled at the microvascular level (with constant permeability) by the difference between capillary (CP) and interstitial (IP) pressures. In healthy subjects, subcutaneous IP is discreetly negative (-1 mmHg) and varies very little. On the other hand, a sometimes drastic decrease in IP has been described in various localized and systemic inflammatory situations. These pressure variations may be explained by the collagen structure of the interstitial tissue and a change in the three-dimensional conformation of these macromolecules induced by inflammation mediators. In an animal model of sepsis, a study showed significantly lower pressure in a group of animals in endotoxic shock. IP has never been measured in humans during sepsis. The objective of this study is to analyze subcutaneous IP (SCIP) in patients with septic shock compared with controls in order to evaluate the direct role of interstitial tissue in the onset of edema during sepsis.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Dijon, Francia, 21079
- CHU de DIJON
-
Lyon, Francia, 69003
- HCL - Hôpital Edouard Herriot
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
Criteria common to both groups:
- Adult,
- Admitted within the last 24 hours in intensive care,
- Under mechanical ventilation with orotracheal intubation,
- Without clinically detectable edema (in any area)
- Patient and/or guardian and/or close relative has given written consent
Patients included in the "septic shock" arm:
- Diagnosis of septic shock as defined by the "Sepsis-3" Consensus Conference (JAMA 2016) (34): documented or highly suspected infection with SOFA ≥ 2, persistent hypotension after correction of hypovolemia requiring vasopressor administration, and serum lactate > 2 mmol/l.
- Vascular filling < 50 ml/kg
Patients included in the control arm:
-
Absence of sepsis and shock from any cause:
- PAS > 100 mmHg
- Absence of vasopressors
- Preserved urine > 0.5 ml/kg/h
- Normal serum lactate
-
Crystalloid infusions < 50ml/kg over the previous 12 hours
Exclusion Criteria:
- not affiliated to national health insurance
- under court protection
- pregnant or breastfeeding
- Clinical disseminated intravascular coagulation (DIC) with hemorrhagic syndrome
- Admitted after resuscitation for cardiac arrest
- Presenting cardiogenic shock
- Presenting acute pancreatitis
- Severe overall dehydration (clinical signs of dehydration and natremia > 150mmol/l)
- Presenting metformin intoxication
- In severe sepsis or septic shock for more than 24 hours,
- Dying or for whom death seems imminent (within 24 hours),
- Hypersensitivity to lidocaine and/or prilocaine or local anesthetics of the amide type or to any of the excipients of EMLAPATCH®
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Otro: Control
|
Subcutaneous interstitial measurement at D1 and D2 |
|
Otro: Shock séptico
|
Subcutaneous interstitial measurement at D1 and D2 |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Value of Initial subcutaneous interstitial pressure
Periodo de tiempo: Day 0
|
Measure the difference between the subcutaneous interstitial pressure of patients in septic shock compared to patients without sepsis |
Day 0
|
Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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 (Actual)
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
Otros números de identificación del estudio
- DARGENT 2018
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.
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. .