NCT00807885

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Baxter Healthcare Corporation · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Dehydration

Interventions

Type	Name	Description
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

Timeline

• Start date: 2008-12-01
• Primary completion: 2009-01-01
• Completion: 2009-01-01
• First posted: 2008-12-12
• Last updated: 2011-10-26
• Results posted: 2011-10-18

Locations

2 sites across 1 country: United States