Immuno Nutrition by L-citrulline for Critically Ill Patients (Immunocitre)
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This is a multicentric therapeutic trial, randomized and double blind: standard enteral nutrition plus L-citrulline (5 grams/12 Hours for 5 days from the admission in Intensive Care Unit (ICU)) versus standard enteral nutrition plus placebo.
Methods-Patients: Non-surgical patients admitted in medical intensive care unit, under mechanical ventilation for an expected duration > 2 days, without severe sepsis or septic shock, will be enrolled. Symptoms leading for ICU admission ongoing for five days maximum. On admission (before treatment), the severity will be evaluated with the Sepsis-related Organ Failure Assessment (SOFA) score together with an assessment of plasmatic arginine, cytokines (InterLeukin-6 (IL6) ), and expression of Human Leukocyte Antigen - antigen D Related (HLA-DR) by monocytes. The same evaluation will be repeated on day 3 (during treatment) and on day 7 (after treatment).
The enrolment of 100 patients is statistically enough to demonstrate a decreased SOFA scores in the L-citrulline group as compared to the placebo group on day 7.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Angers, Francia
- CHU Angers
-
Nantes, Francia
- CHU Nantes
-
Paris, Francia
- Paris - HEGP
-
Rennes, Francia, 35033
- Rennes Hospital University
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- age > 18 years
- medical patient (absence of recent surgery or trauma)
- initial aggression < 5 days
- mechanically ventilated with expected duration of mechanical ventilation > 2 days
- exclusive enteral nutrition
- absence of previous immunosuppression
Exclusion Criteria:
- severe sepsis
- septic shock
- obesity defined as BMI above 40
- pregnancy
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: L-Citrulline group
Enteral nutrition 5-day L-citrulline treatment (10 grams/day)
|
|
|
Comparador de placebos: Control group
Enteral nutrition 5-day placebo treatment
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Organ failure score comparison D7
Periodo de tiempo: At day 7
|
Organ failure score (SOFA score) on day 7 in the L-citrulline group as compared to the placebo group
|
At day 7
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Organ failure score comparison D3
Periodo de tiempo: At day 3
|
Organ failure score (SOFA score) on day 3 in the L-citrulline group as compared to the placebo group
|
At day 3
|
|
SOFA score evolution between randomisation and D7
Periodo de tiempo: up to 7 days
|
Binary criterion of success or failure : - Success is defined by: an improved SOFA score of at least 2 points from randomization to Day 7 or an improvement in the general condition yielding the release of the unit; - Failure is defined by an improved SOFA score but less than 2 points, no improvement or worsening of the SOFA score from randomization to Day 7 or the patient's death before J7; |
up to 7 days
|
|
Expression of HLA-DR
Periodo de tiempo: At day 7
|
Expression of HLA-DR in the L-citrulline group as compared to the placebo group
|
At day 7
|
|
Plasmatic concentration of IL6
Periodo de tiempo: At day 7
|
Comparison of the plasmatic concentration of interleukin-6 between the L-citrulline group and the placebo group
|
At day 7
|
|
HLA-DR
Periodo de tiempo: At day 7
|
Comparison of the percentage of expression of monocytic HLA-DR between the L-citrulline group and the placebo group
|
At day 7
|
|
Plasmatic concentration of L-arginine
Periodo de tiempo: At day 7
|
Comparison of the plasmatic concentration of L-arginine and its metabolites between the L-citrulline group and the placebo group
|
At day 7
|
|
Incidence of nosocomial infections
Periodo de tiempo: during the stay in the ICU, an average of 7 days
|
Comparison between the L-citrulline group and the placebo group
|
during the stay in the ICU, an average of 7 days
|
|
Length of stay
Periodo de tiempo: during the stay in hospital, up to 28 days
|
Length of stay in ICU and hospital: Comparison between the L-citrulline group and the placebo group
|
during the stay in hospital, up to 28 days
|
|
Mortality
Periodo de tiempo: during the stay in hospital, up to 28 days
|
|
during the stay in hospital, up to 28 days
|
|
Duration of mechanical ventilation
Periodo de tiempo: during the stay in ICU, an average of 7 days
|
Duration of mechanical ventilation: Comparison between the L-citrulline group and the placebo group
|
during the stay in ICU, an average of 7 days
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Jean-Marc TADIE, MD, CHU Rennes
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 (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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 35RC14_9835
- 2015-A00961-48 (Otro identificador: Id-RCB)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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. .