Phase IV Randomized Study of Hylenex or Standard IV Hydration in the Pediatric Population With Moderate Dehydration
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Cardiac Output Trends
研究概览
简要总结
The purpose of this study is to non-invasively study the reflective changes in cardiac output as response to fluid therapy in the pediatric moderate hypovolemia/dehydrated pediatric patients using sub-q rehydration using Hylenex augmented subcutaneous infusion of fluids and electrolytes compared to intravenous methods.
详细描述
This is an open-labeled, single-center Phase IV clinical trial. The study will consist of patients with moderate hypovolemia/dehydration requiring parenteral rehydration. It is expected that this study will describe the onset or change in cardiac output using Hylenex augmented subcutaneous rehydration from ages 2 months up to 3 years and at a flow rate satisfying clinical needs, especially in reference to changes in cardiac output observed in standard intravenous rehydration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 2 Months 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients presenting to the Emergency Department (ED) with moderate dehydration (gorelick dehydration classification : presence of 3-6 moderate signs and symptoms) requiring parenteral rehydration.
- •Patient has not successfully received oral or IV fluids immediately prior to enrollment
- •patient's legally authorized representative has signed the informed consent and is willing for the patient to receive Hylenex augmented sub-q rehydration
排除标准
- •patient in shock or a life-threatening situation
- •immunocompromised, history of abscess or cellulitis, abscess &/or cellulitis caused by Methicillin-resistant Staphylococcus aureus (MRSA), family history of abscess or cellulitis
- •requires IV therapy for another indication
- •has an indwelling catheter
- •has already received rehydration therapy by IV route within the last 48 hours or substantial oral fluid in the immediate time period of enrollment
- •has a condition precluding sub-q injection or infusion site evaluation in the upper middle back area or at another elected site of infusion
- •has a reason for hospital admission or extended ED stay other than dehydration
- •has an known hypersensitivity to hyaluronidase or another ingredient in the formulation of Hylenex
- •has a know hyponatremia < 130 milliequivalents per liter (mEq/L) or hypernatremia >155 mEq/L
- •has a know hypokalemia <3.0 mEq/L
- •has a medical condition likely to interfere with the patients ability to fully complete the study protocol or the ability to have the protocol-specified assessments
- •has a medical history, screening physical exam finding or historical clinical lab result that in the opinion of the investigator would preclude the patients safe participation in the is study or which might adversely effect the interpretation of the study results
- •patient participated in a study of any investigational drug or device within 230 days prior to enrollment in this study
研究组 & 干预措施
Hylenex
1ml subcutaneous with initiation of intravenous fluids then every 24 hours with a maximum dose of 3 injections in 72 hours
干预措施: Hylenex (Drug)
结局指标
主要结局
Cardiac Output Trends
时间窗: Measurements and data are recorded only while patient is receiving care in the Emergency Department (ED). A f/u call is made on day 3 and/or day 7 post enrollment into the study.
Describe the cardiac output trends measured in liters per minute (onset and changes in slope over time) by noninvasively monitoring methods in pediatric patients being rehydrated by Hylenex augmented subcutaneous rehydration or routine IV rehydration
次要结局
- Gorelick Assessment(Measurements and data are recorded only while patient is receiving care in the ED. A f/u call is made on day 3 and/or day 7 post enrollment into the study.)
研究者
Thomas Abramo
Professor
Vanderbilt University Medical Center