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

Dehydration Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00807885
• Other study ID #: 1838-007
• Status: Completed
• Phase: Phase 4
• First received: December 10, 2008
• Last updated: October 21, 2011
• Start date: December 2008
• Est. completion date: January 2009

Study information

• Verified date: October 2011
• Source: Baxter Healthcare Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Dehydration

Intervention

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

Locations

Country	Name	City	State
United States	MDS Pharma Services	Lincoln	Nebraska
United States	MDS Pharma Services	Neptune	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Baxter Healthcare Corporation	Halozyme Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	throughout subcutaneous hylenex and fluid administration period (continuous)	No
Secondary	Attempts Needed to Successfully Place Subcutaneous Catheter/Button		from start of first attempt until completion of catheter/button placement	No
Secondary	Time Needed to Successfully Place Subcutaneous Catheter/Button		from start of first attempt until completion of catheter/button placement	No
Secondary	Time Required to Infuse 1000 mL Fluid		from start of Lactated Ringer's (LR) infusion until 1000 mL LR infused	No