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

Baxter

Status and phase: Completed; Phase 4

Conditions: Dehydration

Treatments: Drug: hylenex-facilitated subcutaneous Lactated Ringer's infusion

Study type: Interventional

Funder types: Industry

Identifiers

NCT00807885

1838-007

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 9 patient groups

Tegaderm-secured 24 ga Teflon catheter

Experimental group

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

Treatment:

Drug: hylenex-facilitated subcutaneous Lactated Ringer's infusion

Tape-secured 24 ga Teflon catheter

Experimental group

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

Treatment:

Drug: hylenex-facilitated subcutaneous Lactated Ringer's infusion

Tegaderm-secured 24 ga polyurethane catheter

Experimental group

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

Treatment:

Drug: hylenex-facilitated subcutaneous Lactated Ringer's infusion

Tape-secured 24 ga polyurethane catheter

Experimental group

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

Treatment:

Drug: hylenex-facilitated subcutaneous Lactated Ringer's infusion

Tegaderm-secured 20 ga Teflon catheter

Experimental group

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

Treatment:

Drug: hylenex-facilitated subcutaneous Lactated Ringer's infusion

Tape-secured 20 ga Teflon catheter

Experimental group

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

Treatment:

Drug: hylenex-facilitated subcutaneous Lactated Ringer's infusion

Tegaderm-secured 20 ga polyurethane catheter

Experimental group

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

Treatment:

Drug: hylenex-facilitated subcutaneous Lactated Ringer's infusion

Tape-secured 20 ga polyurethane catheter

Experimental group

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

Treatment:

Drug: hylenex-facilitated subcutaneous Lactated Ringer's infusion

SC button with 27 ga X 9 mm needle

Experimental group

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)

Treatment:

Drug: hylenex-facilitated subcutaneous Lactated Ringer's infusion