Comparing Outcome of Early Versus Conventional Intubation Practice in Children with Fluids Refractory Septic Shock-An Open Label Randomized Control Trial.
试验速览
- 阶段
- 1/2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- To Compare Mortality in Early versus Conventional Intubation in Children with Fluids Refractory Septic Shock
研究概览
简要总结
This Study is An Open Label Randomized Controlled Trial With a Expected Sample Size Of 104 Patients Comparing Outcome of Early Intubation Versus Conventional Intubation in Children With Fluids Refractory Septic Shock Presenting in Pediatric Emergency Medicine After Taking Consent from parents and Patients Satisfying Inclusion and Exclusion Criteria. Patients Will be Randomized to Early Intubation and Conventional Intubation Arm. Stratified Block Randomization with Block Size 4 Will be used as Randomization method and Serially Numbered, Opaque, Sealed Envelopes will be used as Allocation Concealment. Primary Outcome- Comparision of 28 days Mortality and Seconadry outcomes includes Shock Resolution Time, Mechanical Ventilation Durations, Inotropes Supports Durations, Hospital Stay Durations, Vasoactive Inotropes Score(VIS), Ventilation Free Days, Percentage Fluids Overloads, Needs of Renal Replacement Therapy(RRT).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 1.00 Month(s) 至 14.00 Year(s)（—）
- 性别
- All
入选标准
- •Children with age 1 months -14 years age with Fluids Refractory Septic Shock will be enrolled after taking Consents from Parents/LAR.
排除标准
- •Severe Anemia with CHF 2)Known cardiac Structural defect 3)known case of End Stage CKD 4)Children already Received Intubated from outside hospital 5)Children already received Fluids bolus from outside hospital 6)Children already received on Inotropes support from outside hospital 7)Post Cardiac Arrest patients.
结局指标
主要结局
To Compare Mortality in Early versus Conventional Intubation in Children with Fluids Refractory Septic Shock
时间窗: 28 days Mortality Comparison
次要结局
- 1)Shock Resolution Time(2)Durations of Mechanical Ventilations)
研究者
Dr Himmat Ram Siyag
AIIMS, Raipur