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OpenTrials
Completed

NCT Number: NCT00807885

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

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.

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Key information

Conditions

Dehydration Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Water-Electrolyte Imbalance

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

MDS Pharma Services, Lincoln, Nebraska, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

hylenex-facilitated subcutaneous Lactated Ringer's infusion

Drug

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Attempts Needed to Successfully Place Subcutaneous Catheter/Button

    Time frame: from start of first attempt until completion of catheter/button placement

  2. Time Needed to Successfully Place Subcutaneous Catheter/Button

    Time frame: from start of first attempt until completion of catheter/button placement

  3. Time Required to Infuse 1000 mL Fluid

    Time frame: from start of Lactated Ringer's (LR) infusion until 1000 mL LR infused

Sponsors and collaborators

Lead sponsor

Baxter Healthcare Corporation

Industry

Collaborators

  • Halozyme Therapeutics

Registry information

Official study 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

Acronym: INFUSE-AT

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Dec 12, 2008
Registry last updated
Oct 26, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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