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

This study has been completed.
Sponsor:
Collaborator:
Halozyme Therapeutics
Information provided by (Responsible Party):
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT00807885
First received: December 10, 2008
Last updated: October 21, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention Phase
Dehydration
Drug: hylenex-facilitated subcutaneous Lactated Ringer's infusion
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Baxter Healthcare Corporation:

Primary Outcome Measures:
  • Technical Challenges [ Time Frame: throughout subcutaneous hylenex and fluid administration period (continuous) ] [ Designated as safety issue: No ]
    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 Frame: from start of first attempt until completion of catheter/button placement ] [ Designated as safety issue: No ]
  • Time Needed to Successfully Place Subcutaneous Catheter/Button [ Time Frame: from start of first attempt until completion of catheter/button placement ] [ Designated as safety issue: No ]
  • Time Required to Infuse 1000 mL Fluid [ Time Frame: from start of Lactated Ringer's (LR) infusion until 1000 mL LR infused ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: December 2008
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Drug: hylenex-facilitated subcutaneous Lactated Ringer's infusion
single subcutaneous 150 U dose of hylenex, followed by subcutaneous infusion of 1000 mL Lactated Ringer's solution
Other Names:
  • hylenex
  • rHuPH20
  • LR
  • LR solution
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
Drug: hylenex-facilitated subcutaneous Lactated Ringer's infusion
single subcutaneous 150 U dose of hylenex, followed by subcutaneous infusion of 1000 mL Lactated Ringer's solution
Other Names:
  • hylenex
  • rHuPH20
  • LR
  • LR solution
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
Drug: hylenex-facilitated subcutaneous Lactated Ringer's infusion
single subcutaneous 150 U dose of hylenex, followed by subcutaneous infusion of 1000 mL Lactated Ringer's solution
Other Names:
  • hylenex
  • rHuPH20
  • LR
  • LR solution
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
Drug: hylenex-facilitated subcutaneous Lactated Ringer's infusion
single subcutaneous 150 U dose of hylenex, followed by subcutaneous infusion of 1000 mL Lactated Ringer's solution
Other Names:
  • hylenex
  • rHuPH20
  • LR
  • LR solution
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
Drug: hylenex-facilitated subcutaneous Lactated Ringer's infusion
single subcutaneous 150 U dose of hylenex, followed by subcutaneous infusion of 1000 mL Lactated Ringer's solution
Other Names:
  • hylenex
  • rHuPH20
  • LR
  • LR solution
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
Drug: hylenex-facilitated subcutaneous Lactated Ringer's infusion
single subcutaneous 150 U dose of hylenex, followed by subcutaneous infusion of 1000 mL Lactated Ringer's solution
Other Names:
  • hylenex
  • rHuPH20
  • LR
  • LR solution
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
Drug: hylenex-facilitated subcutaneous Lactated Ringer's infusion
single subcutaneous 150 U dose of hylenex, followed by subcutaneous infusion of 1000 mL Lactated Ringer's solution
Other Names:
  • hylenex
  • rHuPH20
  • LR
  • LR solution
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
Drug: hylenex-facilitated subcutaneous Lactated Ringer's infusion
single subcutaneous 150 U dose of hylenex, followed by subcutaneous infusion of 1000 mL Lactated Ringer's solution
Other Names:
  • hylenex
  • rHuPH20
  • LR
  • LR solution
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)
Drug: hylenex-facilitated subcutaneous Lactated Ringer's infusion
single subcutaneous 150 U dose of hylenex, followed by subcutaneous infusion of 1000 mL Lactated Ringer's solution
Other Names:
  • hylenex
  • rHuPH20
  • LR
  • LR solution

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00807885

Locations
United States, Nebraska
MDS Pharma Services
Lincoln, Nebraska, United States, 68502
United States, New Jersey
MDS Pharma Services
Neptune, New Jersey, United States, 07753
Sponsors and Collaborators
Baxter Healthcare Corporation
Halozyme Therapeutics
Investigators
Study Director: George Harb, MD, MPH Baxter Healthcare Corporation
  More Information

No publications provided

Responsible Party: Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT00807885     History of Changes
Other Study ID Numbers: 1838-007
Study First Received: December 10, 2008
Results First Received: September 12, 2011
Last Updated: October 21, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Baxter Healthcare Corporation:
dehydration
fluid therapy
hyaluronoglucosaminidase
hyaluronidase
hypodermoclysis
clysis
subcutaneous hydration
subcutaneous rehydration
hyaluronan
rHuPH20

Additional relevant MeSH terms:
Dehydration
Water-Electrolyte Imbalance
Metabolic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 29, 2014