INcreased Flow Utilizing Subcutaneously-Enabled Fluids Administration Technique Study (INFUSE-AT): A Randomized, Open-Label, Parallel Group, Phase IV, Study Evaluating the Techniques of Administration of Subcutaneous Fluids Enabled by Human Recombinant Hyaluronidase (Hylenex) in Healthy Adult Volunteers
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Technical Challenges
研究概览
简要总结
The purpose is to evaluate the ease of use and technical challenges encountered during subcutaneous infusion of Lactated Ringer's (LR) solution, preceded by recombinant human hyaluronidase (hylenex), utilizing commonly used angiocatheter gauges and button delivery systems. The safety and tolerability of hylenex-augmented SC infusion of LR through these delivery systems is also being evaluated.
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
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •male or female, aged 18 to 60 years
- •intact normal skin without potentially obscuring features on both anterior thighs in the area intended for infusion
- •agreeing to no fluid intake for 12 hours prior to start of study infusion
- •vital signs within normal range or, if outside normal range, deemed not clinically significant
- •metabolic panel, hematology, virology and standard 10-test urine dipstick tests within normal range, or if outside normal range, deemed not clinically significant
- •if female of child-bearing potential,negative serum pregnancy tests
- •negative urine drug screens
- •written informed consent for participation
排除标准
- •lower extremity edema
- •lower extremity pathology that could interfere with study outcome
- •history of cardiovascular disease
- •rales on lung auscultation
- •known allergy to hyaluronidase or other ingredient in the formulation of hylenex
- •pregnancy or breast-feeding a child
- •exposure to any experimental drug within 30 days prior to study participation
- •previous participation in this study
研究组 & 干预措施
SC button with 27 ga X 9 mm needle
subcutaneous administration of a single 150 U dose of hylenex, followed by subcutaneous infusion (delivered by large volume infusion pump) of 1000 mL Lactated Ringer's solution, both delivered through a button-type subcutaneous delivery system (with a 27-gauge, 9 mm long metal needle)
干预措施: hylenex-facilitated subcutaneous Lactated Ringer's infusion (Drug)
Tegaderm-secured 24 ga Teflon catheter
subcutaneous administration of a single 150 U dose of hylenex, followed by subcutaneous infusion (delivered by large volume infusion pump) of 1000 mL Lactated Ringer's solution, both delivered through a 24-gauge, 0.75 inch long, Teflon angiocatheter secured with Tegaderm
干预措施: hylenex-facilitated subcutaneous Lactated Ringer's infusion (Drug)
Tape-secured 24 ga Teflon catheter
subcutaneous administration of a single 150 U dose of hylenex, followed by subcutaneous infusion (delivered by large volume infusion pump) of 1000 mL Lactated Ringer's solution, both delivered through a 24-gauge, 0.75 inch long, Teflon angiocatheter secured with a tape double chevron
干预措施: hylenex-facilitated subcutaneous Lactated Ringer's infusion (Drug)
Tegaderm-secured 24 ga polyurethane catheter
subcutaneous administration of a single 150 U dose of hylenex, followed by subcutaneous infusion (delivered by large volume infusion pump) of 1000 mL Lactated Ringer's solution, both delivered through a 24-gauge, 0.75 inch long, polyurethane angiocatheter secured with Tegaderm
干预措施: hylenex-facilitated subcutaneous Lactated Ringer's infusion (Drug)
Tape-secured 24 ga polyurethane catheter
subcutaneous administration of a single 150 U dose of hylenex, followed by subcutaneous infusion (delivered by large volume infusion pump) of 1000 mL Lactated Ringer's solution, both delivered through a 24-gauge, 0.75 inch long, polyurethane angiocatheter secured with a tape double chevron
干预措施: hylenex-facilitated subcutaneous Lactated Ringer's infusion (Drug)
Tegaderm-secured 20 ga Teflon catheter
subcutaneous administration of a single 150 U dose of hylenex, followed by subcutaneous infusion (delivered by large volume infusion pump) of 1000 mL Lactated Ringer's solution, both delivered through a 20-gauge, 1.0 inch long, Teflon angiocatheter secured with Tegaderm
干预措施: hylenex-facilitated subcutaneous Lactated Ringer's infusion (Drug)
Tape-secured 20 ga Teflon catheter
subcutaneous administration of a single 150 U dose of hylenex, followed by subcutaneous infusion (delivered by large volume infusion pump) of 1000 mL Lactated Ringer's solution, both delivered through a 20-gauge, 1.0 inch long, Teflon angiocatheter secured with a tape double chevron
干预措施: hylenex-facilitated subcutaneous Lactated Ringer's infusion (Drug)
Tegaderm-secured 20 ga polyurethane catheter
subcutaneous administration of a single 150 U dose of hylenex, followed by subcutaneous infusion (delivered by large volume infusion pump) of 1000 mL Lactated Ringer's solution, both delivered through a 20-gauge, 1.0 inch long, polyurethane angiocatheter secured with Tegaderm
干预措施: hylenex-facilitated subcutaneous Lactated Ringer's infusion (Drug)
Tape-secured 20 ga polyurethane catheter
subcutaneous administration of a single 150 U dose of hylenex, followed by subcutaneous infusion (delivered by large volume infusion pump) of 1000 mL Lactated Ringer's solution, both delivered through a 20-gauge, 1.0 inch long, polyurethane angiocatheter secured with a tape double chevron
干预措施: hylenex-facilitated subcutaneous Lactated Ringer's infusion (Drug)
结局指标
主要结局
Technical Challenges
时间窗: throughout subcutaneous hylenex and fluid administration period (continuous)
Protocol-specified challenges encountered during subcutaneous (SC) hylenex administration and/or SC infusion of Lactated Ringer's solution, including SC catheter kinking, catheter/button dislodgement, catheter/button pull-out, infusion pump alarm, other pump failure, healthcare provider intervention to secure/maintain SC infusion eg, re-taping, catheter/button manipulation, etc, and any other type of technical challenge encountered
次要结局
- Attempts Needed to Successfully Place Subcutaneous Catheter/Button(from start of first attempt until completion of catheter/button placement)
- Time Needed to Successfully Place Subcutaneous Catheter/Button(from start of first attempt until completion of catheter/button placement)
- Time Required to Infuse 1000 mL Fluid(from start of Lactated Ringer's (LR) infusion until 1000 mL LR infused)