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

NCT00807885 | Completed Phase 4 Results

• 1 other identifier: 1838-007
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

dehydration; fluid therapy; hyaluronoglucosaminidase; hyaluronidase; hypodermoclysis; clysis; subcutaneous hydration; subcutaneous rehydration; hyaluronan; rHuPH20

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (3)

• Attempts Needed to Successfully Place Subcutaneous Catheter/Button

  from start of first attempt until completion of catheter/button placement

• Time Needed to Successfully Place Subcutaneous Catheter/Button

  from start of first attempt until completion of catheter/button placement

• Time Required to Infuse 1000 mL Fluid

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

Study Arms (9)

Tegaderm-secured 24 ga Teflon catheter

EXPERIMENTAL

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

Tape-secured 24 ga Teflon catheter

EXPERIMENTAL

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

Tegaderm-secured 24 ga polyurethane catheter

EXPERIMENTAL

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

Tape-secured 24 ga polyurethane catheter

EXPERIMENTAL

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

Tegaderm-secured 20 ga Teflon catheter

EXPERIMENTAL

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

Tape-secured 20 ga Teflon catheter

EXPERIMENTAL

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

Tegaderm-secured 20 ga polyurethane catheter

EXPERIMENTAL

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

Tape-secured 20 ga polyurethane catheter

EXPERIMENTAL

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

SC button with 27 ga X 9 mm needle

EXPERIMENTAL

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

Interventions

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

Also known as: hylenex, rHuPH20, LR, LR solution

SC button with 27 ga X 9 mm needle; Tape-secured 20 ga Teflon catheter; Tape-secured 20 ga polyurethane catheter; Tape-secured 24 ga Teflon catheter; Tape-secured 24 ga polyurethane catheter; Tegaderm-secured 20 ga Teflon catheter; Tegaderm-secured 20 ga polyurethane catheter; Tegaderm-secured 24 ga Teflon catheter; Tegaderm-secured 24 ga polyurethane catheter

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Baxter Healthcare Corporation: lead
• Halozyme Therapeutics: collaborator

Study Sites (2)

MDS Pharma Services

Lincoln, Nebraska, 68502, United States

Location

MDS Pharma Services

Neptune City, New Jersey, 07753, United States

Location

MeSH Terms

Conditions

Dehydration

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: George Harb, MD, MPH
• Organization: Baxter Healthcare Corporation

george_harb@baxter.com

Study Officials

• George Harb, MD, MPH

  Baxter Healthcare Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2008
• First Posted: December 12, 2008
• Study Start: December 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: October 26, 2011
• Results First Posted: October 18, 2011

Record last verified: 2011-10

Locations

US (2)