Permissive Hyperthermia in Acute Brain Injury
Permissive Hyperthermia in Traumatic Brain Injury and Acute Vascular Brain Injury
The purpose of this pilot study is to find out whether it is possible to work together with the body's own reactions, where the temperature goes up (fever), in a safe and controlled way.
The main question to answer is:
Is it practical and safe to allow higher body temperature (up to 39.5°C) as part of the treatment for critically ill patients with brain injury?
Patients with acute brain injury will be Placed in one of two groups: one where fever is treated to keep the temperature below 37.5°C, and one where fever is allowed up to 39.5°C.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Background Fever is common in patients with acute brain injury and is routinely suppressed despite limited evidence from randomized trials demonstrating benefit. Observational studies associate hyperthermia with worse outcomes, but it remains unclear whether fever is causative or reflects injury severity. Experimental and clinical data suggest that temperature reduction may adversely affect cerebral perfusion pressure and brain tissue oxygenation. This pilot study evaluates the feasibility and safety of permissive hyperthermia compared with standard normothermic care in neurocritical patients with severe acute brain injury.
Methods The investigators conduct a prospective, randomized, open-label pilot study in a neurointensive care unit. Twenty adult patients with severe acute brain injury requiring mechanical ventilation, sedation, and intracranial pressure monitoring are randomized 1:1 to permissive hyperthermia or standard care. In the intervention group, fever is tolerated up to 39.5°C, whereas the control group receives active temperature control from 37.5°C according to current practice. All patients are monitored using a multimodal intracranial system enabling continuous intracranial pressure and brain tissue oxygen tension measurement, cerebral microdialysis, and transcranial Doppler ultrasonography. Primary outcome is feasibility, defined by the need for temperature-lowering interventions due to refractory intracranial hypertension. Secondary outcomes include intracranial pressure, cerebral perfusion pressure, brain tissue oxygenation, cerebral metabolism, vasopressor requirements, length of stay, and functional status.
Results This is an ongoing pilot study. Recruitment feasibility, protocol adherence, and safety outcomes will be reported. Interim safety analysis is planned after inclusion of 10 patients.
Conclusions This pilot study will provide essential feasibility and safety data on permissive hyperthermia in severe acute brain injury. The results will inform the design of a future multicenter study.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Odense C, Dinamarca, 5000
- Neurointensiv care
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Severe acute brain injury.
- Requirement for:
Mechanical ventilation Sedation Intracranial pressure (ICP) monitoring
Exclusion Criteria:
- Pregnancy
- Moribund patients or patients in whom withdrawal of active treatment is anticipated
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Permissive hyperthermia
Permissive hyperthermia allowed up to 39.5°C before intervention
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Allowing temperature up to 39,5 in patients with acute brain injury
Otros nombres:
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Comparador activo: Standard temperature control
Normothermia actively maintained per current standard
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Standard care of temperature
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Record numbers of episodes and the time frame when temperature needed to be lowered to maintain acceptable intracranial pressure.
Periodo de tiempo: 14 days from enrollment, or until multi-bolt has been removed, or the patients had died
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This only applies to patients included in the group, where temperatures up to 39.5°C are allowed
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14 days from enrollment, or until multi-bolt has been removed, or the patients had died
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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
- OP_2717
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
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.
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