Prevalence, Severity, Risk Factors, and Prognostic Value of Hyponatremia in Patients With Traumatic Brain Injury (WATERWAR)
Prevalence, Severity, Risk Factors, and Prognostic Value of Hyponatremia in Patients With Traumatic Brain Injury : a Retrospective Cohort Study.
Hyponatremia (HN) is the most common electrolytic disorder in the traumatic brain injury (TBI) population, found in 17 to 51% of patients according to the series. Two etiologies predominate in the literature, the Syndrome of Inappropriate Anti Diuretic Hormone (SIADH) and the Cerebral Salt Waste Syndrome (CSW), but none has been precisely described in terms of epidemiology, risk factors or severity. Moreover, SIADH and CSH were often confused in previous works.
The main goal of our study is to assess retrospectively prevalence, severity, time to onset, length, risk factors of HN in a large population of TBI patients, as well as treatment modalities and prognosis. A specific distinction was performed between SIADH or CSW.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
This is a retrospective descriptive study.
The included patients will be those admitted in the trauma intensive care unit of Lapeyronie University Hospital (Montpellier, France) with a TBI (head AIS ≥1) during a period of 4 years, 01/01/2014 to 31/12/2017.
Using our databank the investigators estimate 650 to 700 patients who met inclusion criteria during this period and will be analyzed. Inclusions will be confirmed after the opening of medical records.
Definition of SIADH is defined as the occurrence of a hyponatremia (≤135 mmol/L) associated with inappropriate urine concentration (urinary/plasmatic osmolarity ≥1) and a low daily urine volume (<1500 ml/24H).
Definition of CSW is defined as the occurrence of a hyponatremia (≤135 mmol/L) associated with a massive natriuresis (>140 mmol/L) and a daily urine volume > 1500 ml/24H.
Data collection will concern the medical records: medical history, traumatism severity, cerebral injuries on computed tomography, severe complications, specific treatments, and biological course from ICU admission to discharge.
The main endpoint will be the prevalence of hyponatremia (≤135 mmol/L) in the first 10 days after the traumatic brain injury.
The secondary endpoints will be the prevalence specific prevalence of CSW and SIADH, risk factors of these nosological entities, their severity, their timing to onset and their morbimorality.
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Jonathan CHARBIT, MD
- Número de teléfono: 33 467338256
- Correo electrónico: j-charbit@chu-montpellier.fr
Ubicaciones de estudio
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Montepllier
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Montpellier, Montepllier, Francia, 34295
- Reclutamiento
- Uhmontpellier
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Contacto:
- Jonathan CHARBIT, MD
- Número de teléfono: 33 467338256
- Correo electrónico: j-charbit@chu-montpellier.fr
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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:
- âge ≥ 18 years
- presence of traumatic brain injury at the ICU admission
Exclusion criteria:
- Discharged from ICU or death < 48 hours from the admission
- Lack of data
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Grupo
- Perspectivas temporales: Retrospectivo
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Occurrence of hyponatremia
Periodo de tiempo: during the 10 first days after the traumatic brain injury
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Hyponatremia ≤ 135mmol/L
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during the 10 first days after the traumatic brain injury
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Occurrence SIADH
Periodo de tiempo: during the 10 first days after the traumatic brain injury
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Hyponatremia ≤ 135mmol/L associated with inappropriate urine concentration (urinary/plasmatic osmolarity ≥1) and a low daily urine volume (<1500 ml/24H).
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during the 10 first days after the traumatic brain injury
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Occurrence CSW
Periodo de tiempo: during the 10 first days after the traumatic brain injury
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Hyponatremia (≤135 mmol/L) associated with a massive natriuresis (>140 mmol/L) and a daily urine volume > 1500 ml/24H
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during the 10 first days after the traumatic brain injury
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Determination of risk factors of hyponatremia
Periodo de tiempo: during the 10 first days after the traumatic brain injury
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Traumatics injuries, early management, early complications, sodium and water intakes, treatments.
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during the 10 first days after the traumatic brain injury
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Morbi-mortality
Periodo de tiempo: Day 1 (Hospitalization)
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Death, duration of mechanical ventilation, duration of renal replacement therapy, length of ICU stay and length of hospitalization.
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Day 1 (Hospitalization)
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Jonathan CHARBIT, MD, University Hospital, Montpellier
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- RECHMPL22_0011
Plan de datos de participantes individuales (IPD)
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Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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Ensayos clínicos sobre Lesión cerebral traumática
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University of Dublin, Trinity CollegeDesconocidoAtletas de élite retirados de Brain Health
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Assiut UniversityTerminadoMorfometría basada en Brain Voxel en ManiaEgipto