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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
single subcutaneous 150 U dose of hylenex, followed by subcutaneous infusion of 1000 mL Lactated Ringer's solution
MDS Pharma Services
Lincoln, Nebraska, United States
MDS Pharma Services
Neptune City, New Jersey, United States
Technical Challenges
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
Time frame: throughout subcutaneous hylenex and fluid administration period (continuous)
Attempts Needed to Successfully Place Subcutaneous Catheter/Button
Time frame: from start of first attempt until completion of catheter/button placement
Time Needed to Successfully Place Subcutaneous Catheter/Button
Time frame: from start of first attempt until completion of catheter/button placement
Time Required to Infuse 1000 mL Fluid
Time frame: from start of Lactated Ringer's (LR) infusion until 1000 mL LR infused
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