Study of Techniques of Subcutaneous Administration of Fluids Enabled by Human Recombinant Hyaluronidase (INFUSE-AT)
October 21, 2011 updated by: Baxter Healthcare Corporation
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
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Nebraska
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Lincoln, Nebraska, United States, 68502
- MDS Pharma Services
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-
New Jersey
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Neptune, New Jersey, United States, 07753
- MDS Pharma Services
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Tegaderm-secured 24 ga Teflon catheter
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
|
single subcutaneous 150 U dose of hylenex, followed by subcutaneous infusion of 1000 mL Lactated Ringer's solution
Other Names:
|
|
EXPERIMENTAL: Tape-secured 24 ga Teflon catheter
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
|
single subcutaneous 150 U dose of hylenex, followed by subcutaneous infusion of 1000 mL Lactated Ringer's solution
Other Names:
|
|
EXPERIMENTAL: Tegaderm-secured 24 ga polyurethane catheter
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
|
single subcutaneous 150 U dose of hylenex, followed by subcutaneous infusion of 1000 mL Lactated Ringer's solution
Other Names:
|
|
EXPERIMENTAL: Tape-secured 24 ga polyurethane catheter
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
|
single subcutaneous 150 U dose of hylenex, followed by subcutaneous infusion of 1000 mL Lactated Ringer's solution
Other Names:
|
|
EXPERIMENTAL: Tegaderm-secured 20 ga Teflon catheter
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
|
single subcutaneous 150 U dose of hylenex, followed by subcutaneous infusion of 1000 mL Lactated Ringer's solution
Other Names:
|
|
EXPERIMENTAL: Tape-secured 20 ga Teflon catheter
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
|
single subcutaneous 150 U dose of hylenex, followed by subcutaneous infusion of 1000 mL Lactated Ringer's solution
Other Names:
|
|
EXPERIMENTAL: Tegaderm-secured 20 ga polyurethane catheter
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
|
single subcutaneous 150 U dose of hylenex, followed by subcutaneous infusion of 1000 mL Lactated Ringer's solution
Other Names:
|
|
EXPERIMENTAL: Tape-secured 20 ga polyurethane catheter
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
|
single subcutaneous 150 U dose of hylenex, followed by subcutaneous infusion of 1000 mL Lactated Ringer's solution
Other Names:
|
|
EXPERIMENTAL: SC button with 27 ga X 9 mm needle
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)
|
single subcutaneous 150 U dose of hylenex, followed by subcutaneous infusion of 1000 mL Lactated Ringer's solution
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Technical Challenges
Time Frame: 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
|
throughout subcutaneous hylenex and fluid administration period (continuous)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Attempts Needed to Successfully Place Subcutaneous Catheter/Button
Time Frame: from start of first attempt until completion of catheter/button placement
|
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
|
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
|
from start of Lactated Ringer's (LR) infusion until 1000 mL LR infused
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2008
Primary Completion (ACTUAL)
January 1, 2009
Study Completion (ACTUAL)
January 1, 2009
Study Registration Dates
First Submitted
December 10, 2008
First Submitted That Met QC Criteria
December 11, 2008
First Posted (ESTIMATE)
December 12, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
October 26, 2011
Last Update Submitted That Met QC Criteria
October 21, 2011
Last Verified
October 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1838-007
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.