Clinical trial NCT00807885: Study of Techniques of Subcutaneous Administration of Fluids Enabled by Human Recombinant Hyaluronidase
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dehydration
Keywords: dehydration
fluid therapy
hyaluronoglucosaminidase
hyaluronidase
hypodermoclysis
clysis
subcutaneous hydration
subcutaneous rehydration
hyaluronan
rHuPH20
Lead sponsor: Baxter Healthcare Corporation
Sponsor class: INDUSTRY
Collaborators: name: Halozyme Therapeutics
First posted: 2008-12-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Technical Challenges
timeFrame: throughout subcutaneous hylenex and fluid administration period (continuous)
Secondary outcomes:
measure: Attempts Needed to Successfully Place Subcutaneous Catheter/Button
timeFrame: from start of first attempt until completion of catheter/button placement
measure: Time Needed to Successfully Place Subcutaneous Catheter/Button
timeFrame: from start of first attempt until completion of catheter/button placement
measure: Time Required to Infuse 1000 mL Fluid
timeFrame: from start of Lactated Ringer's (LR) infusion until 1000 mL LR infused
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: MDS Pharma Services
state: Nebraska
city: Neptune
country: United States
facility: MDS Pharma Services
state: New Jersey
Study officials:
affiliation: Baxter Healthcare Corporation
name: George Harb, MD, MPH
role: STUDY_DIRECTOR
References: