NCT07319208招募中3 期
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.
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 760
- 试验地点
- 48
- 主要终点
- Efficacy of early continuous of HSS
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Hypertonic Saline Solution
Experimental
Continuous infusion of HSS (NaCl 20%) for 48 hours (can be prolonged during the period of intracranial hypertension)
干预措施: Hypertonic saline solution (Drug)
Standard
No Intervention
Standard of care
结局指标
主要结局
Efficacy of early continuous of HSS
时间窗: 6 months
Rate of moderate to no dependency in activities in daily living at 6 months is defined as a Barthel Index of independence in activities in daily living ≥ 61.
Efficacy of early continuous of HSS
时间窗: 3 months
Survival : number of patients still alive
次要结局
- Quality of life(until 12 months)
- Neurological recovery(until 12 months)
- Anterograde amnesia(until 6 months)
- Neurocognitive functioning(6 months)
- Cost-effectiveness analysis(12 months)
- Neurological outcome(6 months)
- Genetic biomarkers(12 months)
- Treatment of intracranial hypertension(7 days)
- Tolerance(1 month)
- Neurological recovery(7 days)
- Quality of life(until 12 month)
研究者
研究点 (48)
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