Subcutaneous Rehydration With Hylenex Compared to Intravenous Rehydration in Infants and Young Children With Mild to Moderate Dehydration
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 148
- 试验地点
- 25
- 主要终点
- Mean Total Volume of Fluid Administered at a Single Infusion Site, From the Start to the Cessation of Fluid Administration, for All Randomized Participants
研究概览
简要总结
Randomized (1:1 ratio) study of subcutaneous (SC) versus intravenous (IV) fluid rehydration in mildly to moderately dehydrated pediatric patients.
详细描述
This is a prospective, randomized (1:1 ratio), open-label, parallel group, multicenter, multi-national, study of SC versus IV fluid rehydration in mildly to moderately dehydrated pediatric patients treated in the Emergency Department (ED), inpatient pediatric unit, and/or outpatient urgent care facility. It is expected that up to 186 patients, in order to achieve 148 evaluable patients, will be randomized in a 1:1 ratio to receive isotonic fluid rehydration by either SC administration with hylenex (150 Units) or IV without hylenex.
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
- 30 Days 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children of either gender from one month to ≤10 years of age.
- •Patients with mild or moderate dehydration
- •Healthy child except for the underlying etiology for dehydration
- •Pre-dehydration body weight ≥ 5th percentile for age
- •Parents or legal guardian(s) available to provide informed consent.
排除标准
- •Severe dehydration
- •Shock or life-threatening situation (life expectancy < 10 days).
- •Requirement for IV access for any indication other than for treatment of dehydration.
- •Indwelling IV catheter, except for one intended only for collection of clinical laboratory specimens.
- •Any condition precluding SC infusion or infusion site evaluation
- •Any reason (prior to study enrollment) for a hospital admission or an extended stay in the ED for other than dehydration.
- •Known hypersensitivity to hyaluronidase or hylenex.
- •Known hyponatremia (< 130 milliequivalents per liter [mEq/L]) or hypernatremia (> 155 mEq/L).
- •Known hypokalemia (< 3.0 mEq/L).
- •Any medical condition likely to interfere with the patient's ability to fully complete all protocol-specified interventions, the ability to undergo all protocol-specified assessments, or likely to prolong the patient's need for medical attention beyond that required for treatment of dehydration.
- •Participation in an investigational drug or device study within 30 days prior to enrollment in this study.
研究组 & 干预措施
Subcutaneous
Isotonic fluid rehydration by SC administration with hylenex (150 Units in 1 mL)
干预措施: recombinant human hyaluronidase (Drug)
Intravenous
Isotonic fluid rehydration by IV
干预措施: recombinant human hyaluronidase (Drug)
结局指标
主要结局
Mean Total Volume of Fluid Administered at a Single Infusion Site, From the Start to the Cessation of Fluid Administration, for All Randomized Participants
时间窗: During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)
It was anticipated that most participants in this study would be hydrated through only one infusion site. For participants who received fluid at more than one administration site, a single infusion site was defined as the anatomical site at which the majority of the total infusion volume was infused. The term "anatomical site" was designated as: 1) the back; 2) left thigh; 3) right thigh; 4) abdomen; or 5) chest.
Mean Total Volume of Fluid Administered at a Single Infusion Site, From the Start to the Cessation of Fluid Administration, for Non-rescued Participants
时间窗: During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)
It was anticipated that most participants in this study would be hydrated through only one infusion site. For participants who received fluid at more than one administration site, a single infusion site was defined as the anatomical site at which the majority of the total infusion volume was infused. The term "anatomical site" was designated as: 1) the back; 2) left thigh; 3) right thigh; 4) abdomen; or 5) chest. Participants randomized to receive intravenous isotonic fluid were permitted to receive subcutaneous fluid administration by hylenex-facilitated infusion as rescue.
Mean Total Volume of Fluid Administered at a Single Infusion Site, From the Start to the Cessation of Fluid Administration, for All Rescued Participants
时间窗: During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)
It was anticipated that most participants in this study would be hydrated through only one infusion site. For participants who received fluid at more than one administration site, a single infusion site was defined as the anatomical site at which the majority of the total infusion volume was infused. The term "anatomical site" was designated as: 1) the back; 2) left thigh; 3) right thigh; 4) abdomen; or 5) chest. Participants randomized to receive intravenous isotonic fluid were permitted to receive subcutaneous fluid administration by hylenex-facilitated infusion as rescue.
次要结局
- Mean Total Volume of Fluid Administered at All Infusion Sites, From the Start to the Cessation of Fluid Administration, for All Randomized Participants(During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours))
- Mean Total Volume of Fluid Administered at All Infusion Sites, From the Start to the Cessation of Fluid Administration, for All Randomized Participants Achieving > 200 mL(During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours))
- Mean Total Volume of Fluid Administered at All Infusion Sites, From the Start to the Cessation of Fluid Administration, for Non-rescued Participants Achieving > 200 mL(During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours))
- Mean Total Volume of Fluid Administered at All Infusion Sites, From the Start to the Cessation of Fluid Administration, for All Rescued Participants Achieving > 200 mL(During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours))
- Mean Flow Rate, Delivered Per Unit Time, for All Rescued Participants(During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours))
- Mean Flow Rate, Delivered by Volume Per Unit Body Weight Per Unit Time, for All Non-rescued Participants(During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours))
- Mean Flow Rate, Delivered Per Unit Time, for All Randomized Participants(During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours))
- Mean Flow Rate, Delivered Per Unit Time, for All Non-rescued Participants(During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours))
- Mean Flow Rate, Delivered by Volume Per Unit Body Weight Per Unit Time, for All Rescued Participants(During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours))
- Mean Flow Rate, Delivered by Volume Per Unit Body Weight Per Unit Time, for All Randomized Participants(During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours))
- Number of Participants Achieving a Maximum Flow Rate of > 2 Milliliters Per Minute (mL/Min), as an Indication of Successful Hydration(During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours))
- Number of Participants Administered at Least 200 Milliliter (mL) Total Volume at a Single Infusion Site, From the Start to the Cessation of Fluid Administration(During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours))
- Number of Participants With the Indicated Type of Adverse Events(up to 7 days after hospital discharge)
- Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration(Baseline; after infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours))
- Mean Change From Baseline in Heart Rate(Baseline; after infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours))
- Mean Change From Baseline in Respiratory Rate(Baseline; after infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours))
- Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure(Baseline; after infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours))
- Mean Change From Baseline in the Face, Legs, Activity, Cry, Consolability (FLACC) Pain Scale Score(Before infusion (Baseline); after infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours))
- Number of Participants With the Indicated Type of Fluid Administered(During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours))
- Infusion Duration During the Initial Infusion(first hour of infusion)
- Change From Baseline in Hydration Status According to the Gorelick Assessment at the End of Fluid Infusion(Baseline; during the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours))
- Percent Change From Baseline in Body Weight(Baseline; during the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours))
- Number of Participants With the Indicated Type of Rescue Route Therapy Administered(During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours))
- Number of Participants Classified With the Indicated Healthcare Provider Responses to the Questions Comprising the Healthcare Provider Global Satisfaction Questionnaire(During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours))
- Number of Participants for Which the Indicated Number of Additional Personnel Was Involved in Needle Placement(average of approximately 3 minutes)
- Number of Participants Classified With the Indicated Healthcare Provider Responses to the Question: How Does This Therapy Compare to Your Experience With IV (for SC Group) / SC (for IV Group) Therapy?(During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours))
- Number of Participants Classified With the Indicated Parent/Guardian Responses to the Questions Comprising the Parent / Guardian Global Satisfaction Questionnaire(During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours))
- Number of Participants With the Indicated Number of Different Anatomical Administration Sites Needed After the Start of Fluid Administration(During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours))
- Number of Participants Experiencing Reductions in Flow Rate(During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours))
- Number of Participants Who Received Needle Placement by People With the Indicated Level of Staff Training(average of approximately 3 minutes)
- Time From the Start of Infusion to the Time of Emergency Department (ED) Discharge(up to approximately 26 hours)
- Time From Randomization to the First Drop of Fluid Infusion(up to approximately 110 and 220 minutes for the SC and IV arms, respectively)
- Number of Participants With the Indicated Number of Needle Stick Attempts Needed to Initiate Fluid Administration(average of approximately 3 minutes)
- Number of Participants for Which the Indicated Type of Infusion Device Was Used(average of approximately 3 minutes)
- Number of Participants for Which the Indicated Gauge for Infusion Device Was Used(average of approximately 3 minutes)
- Number of Participants Discharged From the ED to Home or the Hospital(up to approximately 26 hours)
- Number of Participants With the Indicated Reason for Rehospitalization Within 48 and 72 Hours After Discharge(from randomization up to approximately 98 hours)