ISRCTN11038397已完成2 期
Early intravenous beta-blockade with esmolol in adults with isolated severe traumatic brain injury: a Phase 2a intervention design study
orth Bristol NHS Trust0 个研究点目标入组 16 人开始时间: 2021年1月7日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
研究概览
简要总结
2023 Protocol article in https://doi.org/10.1007/s12028-023-01755-9 (added 13/06/2023) 2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38951446/ (added 02/07/2024)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Aged =18 years
- •2. Severe traumatic brain injury (Glasgow Coma Score of 8 or less after resuscitation or prior to intubation)
- •3. Within 24 h of injury
- •4. Intracranial pressure monitoring in situ
排除标准
- •1. Life or limb-threatening extra-cranial injury (as determined by treating intensivist)
- •2. Admitted with perceived devastating brain injury for the purposes of prognostication or organ donation
- •3. Current participation in another clinical trial of an investigational medicinal product or within the preceding 30 days
- •4. Pregnancy
- •5. Breastfeeding
- •6. Hypersensitivity to beta-blockers
- •7. Cardiogenic shock
- •8. Decompensated heart failure (New York Heart Association class 4)
- •9. Untreated sick sinus syndrome or AV nodal conduction disorders including second or third-degree heart block
- •10. Untreated phaeochromocytoma
- •11. Acute severe bronchospasm secondary to asthma or chronic obstructive airways disease
- •12. Severe pulmonary hypertension (mean pulmonary artery pressure >55 mmHg)
- •13. Prinzmetal’s angina
- •14. Severe metabolic acidosis (pH <7.1)
- •15. Use of verapamil within the preceding 48 h
研究者
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