The purpose is to characterize the in-line pressure profiles associated with several infusion technique factors during subcutaneous (SC) infusion of Lactated Ringer's solution, preceded by recombinant human hyaluronidase (hylenex). The safety and tolerability of hylenex-augmented SC infusion of Lactated Ringer's solution fluid is also being evaluated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Subcutaneous administration of 150 U HYLENEX, followed by 1000 mL Lactated Ringer's solution
Kendle International, Inc. Drug Study Unit
Morgantown, West Virginia, United States
Maximum Measured In-line Fluid Pressure
Maximum fluid pressure measured (15 sec period) in delivery line during subcutaneous fluid infusion at specified time point after start of infusion
Time frame: each minute for the first 15 minutes of fluid infusion, every 5 minutes for the next 45 minutes of infusion, and every 15 minutes thereafter until the end of infusion
Number of Attempts Needed for Successful Subcutaneous Catheter/Needle Placement
Time frame: end of catheter/needle placement
Cumulative Fluid Volume Delivered
Time frame: each minute for the first 15 minutes of fluid infusion, every 5 minutes for the next 45 minutes of infusion, and every 15 minutes thereafter until the end of infusion
Technical Challenges Encountered During Fluid Infusion
Observed challenges, including catheter kinking, catheter/needle dislodgement/pull-out, infusion pump alarm, other technical problems
Time frame: at any occurence of a defined challenge or at end of infusion if no challenges occurred
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