Practice of Osmotherapy in Severe SubArachnoid Hemorrhage Patients: Multicenter Observational Study (OSMO-SAH Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- modified Rankin score
研究概览
简要总结
The goal of this prospective multi-center observational study is to learn about the osmotic therapy in severe subarachnoid hemorrhage (SAH). The main question[s] it aims to answer are:
• whether the two osmotic therapy, 20% mannitol and 10% hypertonic saline(HTS), under the same osmotic equivalent, has similar influence on the outcome of SAH patients?
Participants will be given proper treatment according to local expert consensus, including the choice of osmotic medicine. Investigators just record and analyse the data, compare mannitol group and HTS group to see if the outcome of latter is not worse than the former.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •①age ≥18； ②aneurysmal subarachnoid hemorrhage; ③Hunt-Hess 3-5 级
排除标准
- •previous cranial decompression surgery, cerebrospinal fluid leakage or drainage,
- •bilateral pupils fixed or dilated,
- •hemodynamic instability,
- •hemoglobin < 8g / L,
- •serum osmolality > 320 mOsm / L,
- •⑥ combined with severe organ dysfunction (cardiac, pulmonary, hepatic, renal and so on);
- •⑦ serious electrolyte disorders (serum sodium concentration <125 mmol / L or >170 mmol / L), and difficult to correct within limited time;
- •⑧ serious acid-base balance disorders, and difficult to correct within limited time;
- •⑨ use of mannitol or HSS within previous six hours;
- •⑩ being pregnant.
结局指标
主要结局
modified Rankin score
时间窗: 6 months
The Modified Rankin Score (mRS) is the most widely used outcome measure for brain injured patients, which ranges from 0-6. Score of 6 means that patient is dead.
次要结局
未报告次要终点
研究者
Lidan Jiang
Principal Investigator
Xuanwu Hospital, Beijing