NCT02790164已完成2 期
Continuous Neuromuscular Blocking Agent for out-of Hospital Cardiac Arrest; Multicenter Randomized Controlled Trial
Chun Song Youn1 个研究点 分布在 1 个国家目标入组 81 人开始时间: 2016年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Lactate levels 24 hours after initiation of study drug
研究概览
简要总结
The main purpose of this study is to test the hypothesis that continuous NMB could improve outcome in cardiac arrest patients treated with therapeutic hypothermia.
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
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult (older than 19)
- •OHCA with sustained ROSC
- •Comatose (i.e., not following commands) following ROSC
- •Undergoing targeted temperature management (TTM)
- •Time of enrollment ≤ 6hrs from ROSC
排除标准
- •Pre-existing dementia, brain injury, or dependence on others for ADLs (CPC > 3)
- •Traumatic etiology for cardiac arrest
- •Protected population (pregnant, prisoner)
研究组 & 干预措施
Rocuronium
Experimental
Patients will receive a bolus dose of 0.6 mg/kg, then a continuous I.V. infusion of 0.3-0.6 mg/kg/hr as per standard intensive care unit practice.
干预措施: Esmeron (Drug)
Usual Care
Placebo Comparator
Patients will receive 100 mL of normal saline over 5-10 minutes at the beginning of the study in addition to usual care.
干预措施: Saline (Drug)
结局指标
主要结局
Lactate levels 24 hours after initiation of study drug
时间窗: 24 hours
次要结局
- Lactate change over time(0, 12, 24, 36 hrs)
- Survival(Duration of hospitalization, limit 180 days)
- Good neurological outcome(Duration of hospitalization, limit 180 days)
- Length of intensive care unit stay(Duration of ICU stay, limit 180 days)
研究者
Chun Song Youn
Professor
Seoul St. Mary's Hospital
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Sparing in Neuromuscular Blockade in COVID 19 ICUNeuromuscular BlockadeHuman CharacteristicsComplication of Medical CareIntensive Care Unit Acquired WeaknessNCT04459533Hospices Civils de Lyon250
已完成
3 期
Comparison of Sugammadex (MK-8616/Org 25969) With Neostigmine Administered at 1-2 Post-tetanic Counts (PTCs) After Administration of Rocuronium or Vecuronium (19.4.302/P05945/MK-8616-025)Anesthesia, GeneralNCT00473694Merck Sharp & Dohme LLC182
已完成
3 期
Comparison of Sugammadex With Neostigmine During Laparoscopic Cholecystectomy or Appendectomy (P05699)Anesthesia, GeneralNCT00724932Merck Sharp & Dohme LLC140
Unknown
不适用
Neuromuscular Blockade and Surgical ConditionsMorbid ObesityNCT01564576Sheba Medical Center40
已完成
不适用
Neuromuscular Blockade Improves Surgical ConditionsNeuromuscular BlockadeNCT00895778Technical University of Munich57