Jiang Lidan, Qi Meng, Xu Yueqiao, Qu Xin, Chen Wenjin, Cheng Weitao, Zhao Hao, Shang Feng, Fu Xiaotong, Wang Chunxiu, Jiang Rongcai, Wang Ning
Department of Neurosurgery, Xuanwu Hospital Capital Medical University, Beijing, China.
China International Neuroscience Institute, Beijing, China.
BMJ Open. 2025 Jul 25;15(7):e099008. doi: 10.1136/bmjopen-2025-099008.
Hyperosmolar therapy is crucial for the management of cerebral oedema and high intracranial pressure. Mannitol and hypertonic saline (HTS) at different concentrations are commonly used in clinical practice, but evidence of their use is mostly derived from studies about traumatic brain injury. The aim of this study was to evaluate the efficacy and safety of hyperosmolar therapy for severe aneurysmal subarachnoid haemorrhage (SAH).
This is a prospective multicentre observational study in which adult patients with severe aneurysmal SAH (Hunt-Hess score ≥3) will be enrolled. At least 124 patients will be enrolled over 2 years. Each enrolled patient will be treated in accordance with relevant management guidelines. The hypertonic agent used will be 20% mannitol (3 mL/kg) or 10% sodium chloride (HTS) (1 mL/kg). The choice and daily dose of the hypertonic agent will be determined by the attending doctor. The primary outcome will be the modified Rankin scale (mRS) score at 30 days after ictus. The secondary outcomes will be the mRS score at 6 months and the incidence of complications during hospitalisation, including phlebitis, acute kidney injury (AKI), hypokalaemia, hyperkalaemia, hyponatraemia, hypernatraemia, vessel spasm, delayed cerebral ischaemia (DCI), subdural effusion and hydrocephalus. An mRS score 0-2 will indicate a favourable outcome, whereas an mRS score 3-6 will indicate an unfavourable outcome. Logistic analysis will be performed to evaluate the association between the hyperosmolar agent and outcome (favourable or unfavourable).
The aim of this multicentre observational study is to provide evidence on the efficacy and safety of hyperosmolar therapy for severe aneurysmal SAH.
This study was approved by the Ethics Committee of Xuanwu Hospital (approval date: 10 July 2023) under protocol V.2.0 (version date: 26 April 2023) (reference number: [2023]086). The results will be published in a peer-reviewed journal and reported at relevant professional conferences.
NCT05858060.
高渗疗法对于脑水肿和高颅内压的管理至关重要。不同浓度的甘露醇和高渗盐水（HTS）在临床实践中常用，但它们使用的证据大多来自关于创伤性脑损伤的研究。本研究的目的是评估高渗疗法对严重动脉瘤性蛛网膜下腔出血（SAH）的疗效和安全性。
这是一项前瞻性多中心观察性研究，将纳入患有严重动脉瘤性SAH（Hunt-Hess评分≥3）的成年患者。2年内至少将纳入124例患者。每个纳入的患者将按照相关管理指南进行治疗。使用的高渗药物将是20%甘露醇（3 mL/kg）或10%氯化钠（HTS）（1 mL/kg）。高渗药物的选择和每日剂量将由主治医生决定。主要结局将是发病后30天的改良Rankin量表（mRS）评分。次要结局将是6个月时的mRS评分以及住院期间并发症的发生率，包括静脉炎、急性肾损伤（AKI）、低钾血症、高钾血症、低钠血症、高钠血症、血管痉挛、迟发性脑缺血（DCI）、硬膜下积液和脑积水。mRS评分0 - 2表示良好结局，而mRS评分3 - 6表示不良结局。将进行逻辑分析以评估高渗药物与结局（良好或不良）之间的关联。
这项多中心观察性研究的目的是提供关于高渗疗法对严重动脉瘤性SAH的疗效和安全性的证据。
本研究已获得宣武医院伦理委员会批准（批准日期：2023年7月10日），遵循方案V.2.0（版本日期：2023年4月26日）（参考编号：[2023]086）。结果将发表在同行评审期刊上，并在相关专业会议上报告。
NCT05858060。
