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临床试验/NCT02546947
NCT02546947已完成不适用

Monitoring in Intensive Care Unit of Neuromuscular Blocking Agents (NMBA) Used for Acute Respiratory Distress Syndrome (ARDS) After Cardiothoracic Surgery

Centre Chirurgical Marie Lannelongue2 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2015年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
82
试验地点
2
主要终点
cumulative total dose of atracurium (mg per kg per hour, administered from the initial phase of ARDS until disruption ≥48 hours)

研究概览

简要总结

Mortality in Acute Respiratory Distress Syndrome (ARDS) is high (40 to 60 %). Protective mechanical ventilation is the cornerstone of the ARDS therapeutic strategies. Recently, a prospective multicenter study demonstrates that short-term infusion of neuromuscular blocking agents (NMBA) reduces hospital mortality. However, the mechanisms through which NMBAs could improve survival remain speculative and the dose of NMBA needed to observe a beneficial effect is still debated. In hypoxemic ventilated patients, continuous cisatracurium infusion with an objective of no response at orbicularis oculi to train-of-four (TOF) stimulation and an objective of two responses had similar effects on respiratory parameters. In their study, Papazian and colleagues used cisatracurium with an initial standard dose of 15 mg followed by a continuous infusion of 37.5mg/h, based on previous results of studies with patients monitored for paralysis. Atracurium and its stereoisomer cisatracurium are non-depolarizing neuromuscular blocking drugs, both used in anaesthesia and intensive care units.

The aim of this study was to compare in ARDS patients a dose adjustment of continuous-atracurium intravenous infusion with an end point of one or two response at orbicularis oculi to TOF stimulation, and a dose adjustment to achieve clinical goals of protective ventilation without monitoring of TOF stimulation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ARDS with a PaO2 / FiO2 < 200 with a PEEP > 5 since less than 48 hrs
  • Informed consent

排除标准

  • NMBA allergy
  • Continuous administration of NMBA for ARDS prior inclusion
  • Age < 18 yrs

结局指标

主要结局

cumulative total dose of atracurium (mg per kg per hour, administered from the initial phase of ARDS until disruption ≥48 hours)

时间窗: 2 years

was the primary outcome, calculated by the following formula:(Initial bolus dose +(standard bolus dose x number of repetition doses)+cumulative continuous infusion dose (mg/h x number of hours))/ weight (kg) x duration of administration (hour).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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