INcreased Flow Utilizing Subcutaneously-Enabled Pediatric Rehydration (INFUSE-Pediatric Rehydration Study): Phase IV Study of Subcutaneous Rehydration With Recombinant Human Hyaluronidase (HYLENEX) for Infants and Children
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 52
- 主要终点
- HYLENEX-facilitated Subcutaneous (SC) Rehydration Success
研究概览
简要总结
The aim of the study is to evaluate the safety, effectiveness and ease of use of subcutaneous (SC) rehydration using HYLENEX-augmented SC infusion of fluids and electrolytes for the rehydration of pediatric patients with mild to moderate dehydration.
详细描述
Pediatric patients (2 months to 10 years of age), presenting to the emergency department (ED) with mild to moderate dehydration and requiring parenteral rehydration, were treated with HYLENEX-augmented subcutaneous (SC) rehydration. An initial volume of 20 mL/kg of isotonic fluid was to be administered by continuous SC infusion over the first hour, and additional SC rehydration could be continued as clinically indicated. The preferred anatomic site for the SC infusion was the anterior thigh, unless there was an overriding preference for an alternate site.
The duration of HYLENEX-augmented SC rehydration was to be a minimum of 1 hour and a maximum of 72 hours. The investigator or designee performed a clinical assessment of the subject's hydration status at baseline and at the end of SC infusion or at discharge from the ED. Other assessments of effectiveness and safety were made directly during the rehydration period and ED stay, and by telephone on Days 3 and 7 after discharge from the ED.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Months 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child, 2 months to 10 years of age
- •Body weight less than 42 kg
- •Presenting at emergency department with mild to moderate dehydration (Gorelick dehydration classification: presence of 1 to 6 [of possible 10] moderate or severe signs and symptoms) requiring parenteral rehydration
排除标准
- •In shock or life-threatening situation (other than dehydration)
- •Severe dehydration
- •Requires intravenous (IV) therapy for another indication
- •Indwelling IV catheter (excepting one intended strictly for clinical laboratory sample collection)
- •Already received rehydration therapy IV within prior 48 hours or substantial oral fluid immediately before enrollment
- •Condition precluding subcutaneous injection or infusion site evaluation in anterior thigh or other elected infusion site
- •Reason for hospital admission or extended emergency department stay other than dehydration
- •Known hypersensitivity to hyaluronidase or another ingredient in HYLENEX
- •Hyponatremia or hypernatremia
- •Hypokalemia
- •Medical condition likely to interfere with ability to fully complete study or have protocol-specified assessments
- •Medical history, screening examination finding or historical clinical laboratory result precluding safe participation in study or which might adversely effect interpretation of study results
- •Participated in study of any investigational drug or device within 30 days prior to this study
研究组 & 干预措施
HYLENEX-augmented subcutaneous (SC ) rehydration
Single 150 U subcutaneous (SC) HYLENEX dose administered immediately prior to start of SC infusion of rehydration fluid. Additional 150 U HYLENEX dose to be administered prior to any additional fluid infusion beyond 24 hours.
干预措施: hyaluronidase (human recombinant)/rehydration fluid (Drug)
结局指标
主要结局
HYLENEX-facilitated Subcutaneous (SC) Rehydration Success
时间窗: At emergency department discharge (mean time to discharge = 7.03 ± 7.57 hr)
Successfully rehydrated (as medically judged by treating physician) without rescue therapy (ie, without receiving fluids via an alternate route), and discharged to home
Modified HYLENEX-facilitated Subcutaneous (SC) Rehydration Success
时间窗: At emergency department discharge (mean time to discharge = 7.03 ± 7.57 hr)
Successfully rehydrated (as medically judged by treating physician) without rescue therapy (ie, without receiving fluids via an alternate route), regardless of emergency department discharge destination
次要结局
- Number of Attempts Needed to Successfully Place Subcutaneous (SC) Catheter(At end of placement of SC catheter)
- Post-treatment Gorelick Dehydration Score(At baseline and at either the end of subcutaneous infusion (mean duration = 5.73 ± 9.15 hr) or emergency department discharge (mean time to discharge = 7.03 ± 7.57 hr))