Clinical trial NCT01116102: Study of In-line Pressure Using Various Techniques of Subcutaneous Administration of Fluids Enabled by Human Recombinant Hyaluronidase (INFUSE-AT1A)
Official title: The INcreased Flow Utilizing Subcutaneously-Enabled Fluids Administration Technique 1A Study (INFUSE-AT 1A): A Randomized, Parallel Group Study to Evaluate the In-line Pressure, Flow Rate, Safety and Tolerability of Hylenex-facilitated Subcutaneous Fluid Administration In Healthy Volunteers Using Various Subcutaneous Infusion Techniques
Study type: INTERVENTIONAL
Overall status: TERMINATED
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: 2010-05-04
Enrollment: 20
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 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.


Eligibility criteria: Inclusion Criteria:

* Male or female, aged 18 to 60 years, inclusive.
* Body mass index 19.0 to 35.0 kg/m2
* Intact normal skin without potentially obscuring tattoos, pigmentation, or lesions on the upper back in the area intended for infusion
* Free from any clinically significant abnormality on the basis of medical/medication history or physical examination
* Vital signs and clinical laboratory parameters within normal range or, if outside normal range, deemed not clinically significant
* Negative urine drug and alcohol screens.

Exclusion Criteria:

* Upper back pathology that could interfere with study outcome.
* History of congestive heart failure, known coronary heart disease, active or recent pulmonary disease, or renal insufficiency.
* Rales on lung auscultation.
* Known allergy to hyaluronidase or any other ingredient in the formulation of hylenex recombinant
* Treatment with furosemide, benzodiazepines, or phenytoin.
* Pregnancy or breastfeeding.
* Exposure to any experimental drug within 30 days prior to study admission, or previous participation in this study.
* Any other reason which, in the investigator's opinion, would prevent the safe participation in the study.

Primary outcomes:
measure: Maximum Measured In-line Fluid Pressure
timeFrame: 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
Secondary outcomes:
measure: Number of Attempts Needed for Successful Subcutaneous Catheter/Needle Placement
timeFrame: end of catheter/needle placement
measure: Cumulative Fluid Volume Delivered
timeFrame: 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
measure: Technical Challenges Encountered During Fluid Infusion
timeFrame: at any occurence of a defined challenge or at end of infusion if no challenges occurred
Other outcomes:
Locations:
city: Morgantown
country: United States
facility: Kendle International, Inc. Drug Study Unit
state: West Virginia
Study officials:
affiliation: Baxter Healthcare Corporation
name: George Harb, MD, MPH
role: STUDY_DIRECTOR
References: