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Study of Techniques of Subcutaneous Administration of Fluids Enabled by Human Recombinant Hyaluronidase (INFUSE-AT)

Primary Purpose

Dehydration

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
hylenex-facilitated subcutaneous Lactated Ringer's infusion
Sponsored by
Baxter Healthcare Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dehydration focused on measuring dehydration, fluid therapy, hyaluronoglucosaminidase, hyaluronidase, hypodermoclysis, clysis, subcutaneous hydration, subcutaneous rehydration, hyaluronan, rHuPH20

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • MDS Pharma Services
  • MDS Pharma Services

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Tegaderm-secured 24 ga Teflon catheter

Tape-secured 24 ga Teflon catheter

Tegaderm-secured 24 ga polyurethane catheter

Tape-secured 24 ga polyurethane catheter

Tegaderm-secured 20 ga Teflon catheter

Tape-secured 20 ga Teflon catheter

Tegaderm-secured 20 ga polyurethane catheter

Tape-secured 20 ga polyurethane catheter

SC button with 27 ga X 9 mm needle

Arm Description

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

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

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

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

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

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

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

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

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)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Attempts Needed to Successfully Place Subcutaneous Catheter/Button
Time Needed to Successfully Place Subcutaneous Catheter/Button
Time Required to Infuse 1000 mL Fluid

Full Information

First Posted
December 10, 2008
Last Updated
October 21, 2011
Sponsor
Baxter Healthcare Corporation
Collaborators
Halozyme Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT00807885
Brief Title
Study of Techniques of Subcutaneous Administration of Fluids Enabled by Human Recombinant Hyaluronidase
Acronym
INFUSE-AT
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

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baxter Healthcare Corporation
Collaborators
Halozyme Therapeutics

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dehydration
Keywords
dehydration, fluid therapy, hyaluronoglucosaminidase, hyaluronidase, hypodermoclysis, clysis, subcutaneous hydration, subcutaneous rehydration, hyaluronan, rHuPH20

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tegaderm-secured 24 ga Teflon catheter
Arm Type
Experimental
Arm Description
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
Arm Title
Tape-secured 24 ga Teflon catheter
Arm Type
Experimental
Arm Description
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
Arm Title
Tegaderm-secured 24 ga polyurethane catheter
Arm Type
Experimental
Arm Description
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
Arm Title
Tape-secured 24 ga polyurethane catheter
Arm Type
Experimental
Arm Description
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
Arm Title
Tegaderm-secured 20 ga Teflon catheter
Arm Type
Experimental
Arm Description
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
Arm Title
Tape-secured 20 ga Teflon catheter
Arm Type
Experimental
Arm Description
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
Arm Title
Tegaderm-secured 20 ga polyurethane catheter
Arm Type
Experimental
Arm Description
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
Arm Title
Tape-secured 20 ga polyurethane catheter
Arm Type
Experimental
Arm Description
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
Arm Title
SC button with 27 ga X 9 mm needle
Arm Type
Experimental
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
hylenex-facilitated subcutaneous Lactated Ringer's infusion
Other Intervention Name(s)
hylenex, rHuPH20, LR, LR solution
Intervention Description
single subcutaneous 150 U dose of hylenex, followed by subcutaneous infusion of 1000 mL Lactated Ringer's solution
Primary Outcome Measure Information:
Title
Technical Challenges
Description
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)
Secondary Outcome Measure Information:
Title
Attempts Needed to Successfully Place Subcutaneous Catheter/Button
Time Frame
from start of first attempt until completion of catheter/button placement
Title
Time Needed to Successfully Place Subcutaneous Catheter/Button
Time Frame
from start of first attempt until completion of catheter/button placement
Title
Time Required to Infuse 1000 mL Fluid
Time Frame
from start of Lactated Ringer's (LR) infusion until 1000 mL LR infused

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George Harb, MD, MPH
Organizational Affiliation
Baxter Healthcare Corporation
Official's Role
Study Director
Facility Information:
Facility Name
MDS Pharma Services
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68502
Country
United States
Facility Name
MDS Pharma Services
City
Neptune
State/Province
New Jersey
ZIP/Postal Code
07753
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Study of Techniques of Subcutaneous Administration of Fluids Enabled by Human Recombinant Hyaluronidase

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