2024-520205-39-00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.
Centre Hospitalier Universitaire De Nantes22 个研究点 分布在 1 个国家目标入组 760 人开始时间: 2025年8月22日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 760
- 试验地点
- 22
- 主要终点
- The co-primary hierarchic endpoints will be survival at 3 months and moderate to no dependency in activities in daily living at 6 months, which will be assessed centrally by a blinded evaluator.
研究概览
简要总结
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.
入排标准
- 年龄范围
- 0 years 至 65+ years（18-64 Years, 0-17 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Age between 18 – 75 years old
- •Patient admitted to intensive care unit
- •Traumatic brain injury with Glasgow Coma Scale ≤ 12
- •Inclusion during the first 12 hours after Intracranial pressure monitoring placement
- •Informed and signed consent
- •National health insurance
- •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
排除标准
- •Glasgow Coma Scale (score = 3) and persistent abnormal pupillary reactivity despite urgent therapy
- •Patients under court protection
- •Severe hepatic insufficiency: patient presenting with oedemato-ascitic decompensation of liver cirrhosis or patient with Child-Pugh class C cirrhosis
- •Patient who does not speak French
- •Associated cervical spinal cord injury
- •Imminent death and do-not-resuscitate ordersc
- •Coma secondary to cardiac arrest
- •Pregnancy (serum or urine test performed in routine care)
- •Severe Cardiac insufficiency
- •Severe chronic renal insufficiency
- •High risk of follow-up difficulties after ICU discharge
结局指标
主要结局
The co-primary hierarchic endpoints will be survival at 3 months and moderate to no dependency in activities in daily living at 6 months, which will be assessed centrally by a blinded evaluator.
The co-primary hierarchic endpoints will be survival at 3 months and moderate to no dependency in activities in daily living at 6 months, which will be assessed centrally by a blinded evaluator.
次要结局
- Evolution of natremia, chloremia, and plasma osmolarity (7 days)
- Therapeutic intensity level during the first 7 days
- Survival at 1, 6 and 12 months
- EQ-5D-5L at 1, 3, 6 and 12 months (quality-adjusted life year)
- Residency at 1, 3, 6 and 12 months
- G.O.A.T at 1, 3 and 6 months
- MOCA, GOS-E at 6 months
- Rates severe hypernatremia (Na> 160 mmol/L) at Month 1
- Rates of acute kidney injury at Month 1 (KDIGO score 2-3)
- Safety (thrombotic events, central-pontine myelinolysis)
- Incremental cost-effectiveness ratio with a one-year time horizon
- Single nucleotide polymorphism correlated with the clinical outcome
研究者
Pr Antoine ROQUILLY
Scientific
Centre Hospitalier Universitaire De Nantes
研究点 (22)
Loading locations...
相似试验
尚未招募
3 期
Intravenous Hypertonic saline solution in management of patients with Diuretic Resistant Generalized EdemaGENERALIZED EDEMA RESISTANT TO THERAPY.IRCT20200812048380N1Shahid Beheshti University of Medical Sciences28
已完成
不适用
Evaluation of a Hypertonic Seawater Aerosol Therapy Solution in Adults and ChildrenNCT07267689Laboratoires Gilbert110
已完成
3 期
Comparison of the Effects of an Hypertonic Solution With Ringer Lactate on Right Ventricular Function Following Cardiac SurgeryRight Ventricular Impaired FunctionHypovolemiaNCT02782520University Hospital, Grenoble30
已完成
2 期
Preventive Inhalation of Hypertonic Saline in Infants With Cystic FibrosisCystic Fibrosis Lung DiseaseNCT01619657Heidelberg University42
已完成
2 期
Safety & Tolerability of Hypertonic Saline Administration Via Intraosseous AccessIntracranial HypotensionStrokeCerebral EdemaNCT03276494Ohio State University6