Mannitol Versus Hypertonic Saline to Treat Intracranial Hypertension After Severe Traumatic Brain Injury : a Comparative Study on the Effects on PtiO2 and Microdialysis Values
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Effects of HS versus mannitol on lactate/pyruvate ratio
研究概览
简要总结
The purpose of this study is to determine whether hypertonic saline is as much effective as mannitol to treat intracranial hypertension after traumatic brain injury and has at least the same effects on PtiO2 and cerebral metabolism studied through microdialysis.
详细描述
Mannitol is frequently used to treat intracranial hypertension after TBI. However, it can be deleterious, particularly through hyperdiuresis and risks of hypovolemia. It also needs volume compensation and induces logistical problem because of needs of high infused volume to achieve osmolar load and avoid hypotension. Finally, some recent studies tend to prove superiority of hypertonic saline versus mannitol on the prognosis of TBI. especially through modulation of inflammatory reactions mechanisms and apoptosis.
We would like to prove non inferiority of hypertonic saline versus mannitol after TBI to allow its large utilization, especially by field military doctors with specific logistical problems. For that, more than the single Intracranial Pressure, we want to study effects of HS vs mannitol not only on PtiO2 but also on cerebral microdialysis which gives informations on focal metabolism with profiles of ischemia, metabolic crisis, hyperglycolysis (possible reflect of neuronal restoration) and normality.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe Traumatic brain injury monitored with ICP, PtiO2 and cerebral microdialysis
- •And ICP> 20 mm Hg needing osmotherapy
- •And approval of the next of kind
排除标准
- •Bilateral fixed dilated pupils
- •Contra-indication to multimodal neuromonitoring
- •Previous CNS disease
- •Contra-indication to HS (cardiac insufficiency,...)
- •Natremia > 155 mmol/L or osmolarity > 320 mOsm/L
研究组 & 干预措施
Mannitol
干预措施: Mannitol (Drug)
Hypertonic saline
干预措施: Hypertonic saline (Drug)
结局指标
主要结局
Effects of HS versus mannitol on lactate/pyruvate ratio
时间窗: 20 min, 40 min, H1, H2, H3 and H4
次要结局
- Metabolic profile evaluated thanks to measure of lactate/pyruvate ratio and cerebral glucose(20 min, 40 min, H1, H2, H3 and H4)
- Duration of PtiO2 > 15 mm Hg if PtiO2 was < 15 mm Hg before osmotherapy(20 min, 40 min, H1, H2, H3 et H4)
- Duration of ICP<20 mm Hg after osmotherapy(20 min, 40 min, H1, H2, H3 and H4)
- Interstitial osmolarity(20 min, 40 min and H1)
- Necessity of a third line therapy (hypothermia, craniectomy, propofol/barbiturate coma(Day after osmotherapy)
- Length of stay(After leaving the unit)
- Mortality(28th days)
- Glasgow outcome scale(6th month)
研究者
BORET Henry
Médecin en chef
Direction Centrale du Service de Santé des Armées