Sodium Lactate Versus Hypertonic Saline Solution in the Treatment of Intracranial Hypertensive Episodes in Severe Brain Injured Patients
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 52
- 主要终点
- intracranial pressure (ICP)
研究概览
简要总结
Brain oedema is a major complication of brain injury (TBI). It increases the risk of intracranial hypertension (ICH) and brain hypoxia, leading to an increase in mortality and poor neurologic outcome. Increased water content in the injured brain can be related to a vasogenic or cellular pathway. Osmotherapy, by using mannitol or hypertonic saline (HSS), is recommended and currently administered for the treatment of ICH in this setting. Beside these two usual treatments, sodium lactate (SL), a metabolic and neuroprotective solution, has recently been described as having similar effects on lowering intracranial pressure (ICP). In a previous study, conducted in patients with severe TBI, (1) Ichai et al. reported that a bolus of half-molar SL was as effective than equimolar doses of mannitol to reduce elevated ICP (less refractory ICH and higher and longer reduction of ICH).
Objective(s):
The purpose of the study is to analyze the effect on ICH of SL compared to a hypertonic saline solution (HSS).
Outcome(s):
The primary endpoint is the efficacy in lowering ICH after 4 h. Secondary endpoints were percentage of successfully treated episodes of intracranial hypertension and neurological status at discharge from ICU.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with an acute, isolated, severe brain injury (SAH, TBI, ICH)
- •Glasgow coma score <8
- •Monitored using ICP device
- •Presenting an episode of intracranial hypertension requiring osmotherapy. ( defined as increase in ICP 25 mmHg which persisted for more than 5 min in the absence of noxious stimulations)
- •Informed Consent as documented by signature
- •Exclusion criteria
- •Pregnant woman
- •Bilateral fixed dilatated pupils
- •Initial hypernatremia (>155 mmol/l)
- •Penetrating head injury
- •Active participation to another trial (Clin B, C)
排除标准
- 未提供
研究组 & 干预措施
lactate sodium
100 mL of Sodium lactate (Osmolality 2560 mOsm/L) in 15 mins of administration via a central venous catheter
干预措施: Lactate, Sodium (Drug)
Hypertonic Saline solution
single infusion of 100 mL of 7.5% saline (osmolarity, 2560 mOsm/L) (HSS group)in 15 mins of administration via a central venous catheter
干预措施: Hypertonic saline (Drug)
结局指标
主要结局
intracranial pressure (ICP)
时间窗: 240 minutes
Invasive monitoring of intracranial pressure
次要结局
- Percentage of successfully treated episodes(48 hours)
- Oxygen tissular pressure(240 minutes)
- Neurological status at discharge of ICU(through study completion, an average of 30 days)
- Number of episodes of intracranial hypertension(through study completion, an average of 30 days)
研究者
Hervé Quintard
Professor
University Hospital, Geneva