Efficacy of Early Continuous Infusion of HSS on the Neurological Outcome at 6 Months in TBI Patients.

Официальное название

Efficacy of Early Continuous Infusion of Hypertonic Saline Solution on the Neurological Outcome at 6 Months in Traumatic Brain Injured Patients. A Single-blinded, Multicenter, Randomized, Controlled Clinical Trial With Blinded Evaluation of the Primary Outcome.

Обзор

The purpose of this study is to demonstrate the efficacy of early continuous intravenous infusion of hypertonic saline solution (HSS) to improve survival and independence in daily life activities (at 6 months) of patients with traumatic brain injury at high risk of intracranial hypertension.

Вмешательства

• Препарат Hypertonic saline solution
  Continuous infusion of HSS (NaCl 20%) for 48 hours (can be prolonged during the period of intracranial hypertension)

Первичные конечные точки

• Efficacy of early continuous of HSS [Срок оценки: 3 months]
• Efficacy of early continuous of HSS [Срок оценки: 6 months]

Вторичные конечные точки (12)

• Treatment of intracranial hypertension [Срок оценки: 7 days]
• Treatment of intracranial hypertension [Срок оценки: 7 days]
• Treatment of intracranial hypertension [Срок оценки: 7 days]
• Neurological recovery [Срок оценки: 7 days]
• Neurological recovery [Срок оценки: until 12 months]
• Quality of life [Срок оценки: until 12 month]
• Quality of life [Срок оценки: until 12 months]
• Anterograde amnesia [Срок оценки: until 6 months]
• Neurocognitive functioning [Срок оценки: 6 months]
• Neurological outcome [Срок оценки: 6 months]
• Tolerance [Срок оценки: 1 month]
• Tolerance [Срок оценки: 1 month]

Критерии участия

Критерии включения

• Patient admitted to intensive care unit
• Traumatic brain injury with Glasgow Coma Scale ≤ 12
• Intracranial pressure (ICP) monitoring based on the attending physician's clinical judgment, in accordance with guidelines or clinical/radiological signs considered at risk of intracranial hypertension
• Inclusion during the first 12 hours after Intracranial pressure monitoring placement
• Informed and signed consent
• National health insurance

Критерии исключения

• Glasgow Coma Scale (score = 3) and persistent abnormal pupillaryreactivity despite urgent therapy
• Associated cervical spinal cord injury
• Imminent death and do-not-resuscitate orders
• Coma secondary to cardiac arrest
• Pregnancy (serum or urine test performed in routine care)
• Severe Cardiac insufficiency
• Severe chronic renal insufficiency
• Severe hepatic insufficiency: patient presenting with oedemato-ascitic decompensation of liver cirrhosis or patient with Child-Pugh class C cirrhosis
• High risk of follow-up difficulties after ICU discharge
• Patients under court protection
• Patient who does not speak French

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Франция · 23 центра

• CHU d'Angers — Angers
• CHU de Brest — Brest
• CHU Caen Normandie — Caen
• CHU de Clermont- Ferrand — Clermont-Ferrand
• Hôpital BEAUJON APHP — Clichy
• CHU Henri Mondor APHP — Créteil
• CH de Annecy Genevois — Épagny
• CHU de Grenoble — Grenoble
• … и ещё 15 центров

Идентификаторы

NCT: NCT07319208 · RC24_0543 · 2024-520205-39-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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