Continuous Infusion Versus Intermittent Boluses of Cisatracurium in the Early Management of Pediatric Acute Respiratory Distress Syndrome
试验速览
- 阶段
- 4 期
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Duration on mechanical ventilation
研究概览
简要总结
The aim of this work is to compare continuous infusion vs on need intermittent boluses of Cisatracurium in the early management of pediatric acute respiratory distress syndrome
详细描述
In the pediatric population, Acute respiratory distress syndrome (ARDS) has a high mortality rate of approximately 24%. In addition, there is a lack of high-quality data to guide the use of non-depolarizing neuromuscular blocking agents (NMBAs) in mechanically ventilated children. Hence, there is a need to evaluate its use in pediatrics.
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
- 1 Month 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with mild, moderate, and severe ARDS diagnosed according to criteria of Pediatric Acute Lung Injury Consensus Conference (PALICC) in
- •Children of both sexes aged from one month to 18 years.
- •Children diagnosed with ARDS <48 hours before enrollment
排除标准
- •Continuous neuromuscular blockade at enrollment
- •Children on phenytoin and carbamazepine
- •Severe liver cirrhosis
- •High-risk medical illness (Bone marrow transplantation within the last one-year, Diffuse alveolar hemorrhage from vasculitis, Chronic respiratory failure, Burns > 70% total body surface)
- •Previous hypersensitivity or anaphylactic reaction to Cisatracurium
- •Neuromuscular conditions that may potentiate neuromuscular blockade and/or impair effective spontaneous ventilation
研究组 & 干预措施
Intermittent boluses group
Thirty children with ARDS will be managed with intermittent boluses of Cisatracurium (0.1-0.15 mg/kg/dose).
干预措施: Intermittent boluses of Cisatracurium (Drug)
Intravenous infusion for 24 hours
Thirty children with ARDS will be treated with intravenous infusion of Cisatracurium titrated from 1 mic/kg/min till reaching the desired effect for 24 hours.
干预措施: Intravenous infusion of Cisatracurium for 24 hours (Drug)
结局指标
主要结局
Duration on mechanical ventilation
时间窗: Up to 10 days
Time from patient's intubation till extubation
次要结局
- Length of pediatric intensive care unit stay(28 days)
- Length of hospital stay(28 days)
- Mechanical ventilation complications follow-up(28 days)
- Pediatric intensive care unit acquired weakness(28 days)
- Organ failure free days to day 28(28 days)
- Ventilation follow-up(7 days)
- 28-day mortality(28 days)
- Serum Interleukin-8 assessment(48 hours)
研究者
Mohamed Khaled Talaat
Principal Investigator
Tanta University