Study of Techniques of Subcutaneous Administration of Fluids Enabled by Human Recombinant Hyaluronidase
Phase 4
Completed
- Conditions
- Dehydration
- Interventions
- Drug: hylenex-facilitated subcutaneous Lactated Ringer's infusion
- Registration Number
- NCT00807885
- Lead Sponsor
- Baxter Healthcare Corporation
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tegaderm-secured 24 ga Teflon catheter hylenex-facilitated subcutaneous Lactated Ringer's infusion 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 Tape-secured 24 ga Teflon catheter hylenex-facilitated subcutaneous Lactated Ringer's infusion 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 Tegaderm-secured 24 ga polyurethane catheter hylenex-facilitated subcutaneous Lactated Ringer's infusion 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 Tape-secured 24 ga polyurethane catheter hylenex-facilitated subcutaneous Lactated Ringer's infusion 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 Tegaderm-secured 20 ga Teflon catheter hylenex-facilitated subcutaneous Lactated Ringer's infusion 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 Tape-secured 20 ga Teflon catheter hylenex-facilitated subcutaneous Lactated Ringer's infusion 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 Tegaderm-secured 20 ga polyurethane catheter hylenex-facilitated subcutaneous Lactated Ringer's infusion 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 Tape-secured 20 ga polyurethane catheter hylenex-facilitated subcutaneous Lactated Ringer's infusion 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 SC button with 27 ga X 9 mm needle hylenex-facilitated subcutaneous Lactated Ringer's infusion 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)
- Primary Outcome Measures
Name Time Method Technical Challenges 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
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
MDS Pharma Services
🇺🇸Neptune, New Jersey, United States