NCT01120431撤回4 期
The INcreased Flow Utilizing Subcutaneously-Enabled Time-Motion (INFUSE-TM) Study: A Randomized, Open-label, Parallel-group, Multicenter Study Evaluating Efficacy and Time and Resources in the Emergency Department for Hylenex-facilitated Subcutaneous Rehydration Versus Oral Rehydration Therapy in Pediatric Patients With Mild to Moderate Dehydration
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 主要终点
- Total resource utilization in the ED
研究概览
简要总结
The purpose is to evaluate the safety and efficacy as well as the time and resources needed in the ED setting to achieve rehydration in young pediatric subjects with mild to moderate dehydration using hylenex-facilitated SC rehydration versus oral rehydration therapy.
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
- 2 Months 至 2 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female and aged 2 months to 2 years
- •Presenting to ED with mild or moderate dehydration
- •Candidate for both parenteral and oral rehydration therapies
- •Healthy, except for underlying etiology for dehydration
- •Naive to ORT or having received attempted ORT at home for current occurrence of dehydration.
- •Pre-dehydration body weight greater than 5th percentile for age
排除标准
- •Severe dehydration
- •Shock or a life-threatening situation
- •Any condition precluding SC infusion or infusion site evaluation in all possible anatomical locations (upper back, anterior thighs, abdomen, other potential areas) for SC infusion
- •Medical reason or condition precluding administration of ORT
- •Indwelling IV catheter (except one intended only for laboratory sample collection) or anticipated need for IV therapy during the study
- •Anticipated need for hospitalization(other than for rehydration)
- •Known hypersensitivity to hyaluronidase or any other ingredient in the formulation of hylenex recombinant
- •Known hyponatremia, hypernatremia or hypokalemia
- •Medical condition likely to interfere with ability to fully complete protocol-specified interventions and assessments, or likely to prolong need for medical attention beyond that required for rehydration
- •Participation in an investigational drug or device study within 30 days before participation in this study
研究组 & 干预措施
Oral rehydration therapy
Active Comparator
干预措施: Oral rehydration fluid (Other)
hylenex-facilitated SC hydration
Experimental
干预措施: Isotonic hydration fluid and recombinant human hyaluronidase (Drug)
结局指标
主要结局
Total resource utilization in the ED
时间窗: 2 to 8 hours
次要结局
- Rate of successful rehydration in the ED(2 to 8 hours)
- Occurrence of other adverse events(7 days)
- Time to ED discharge(2 to 8 hours)
- Global satisfaction and ease-of-use assessments by healthcare provider(s) and parent/caregiver(2 to 8 hours)
- Occurrence of infusion site pain or other local reactions(2 to 8 hours)
- Amount of rehydration fluid administered(2 to 8 hours)
- Vital signs(2 to 8 hours)
研究者
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终止
不适用
Emergency Department (ED) Flow-directed Fluid Optimization Resuscitation Trial (EFFORT)ShockNCT01128413Washington University School of Medicine22