Skip to content

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
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00807885
Acronym
INFUSE-AT
Enrollment
100
Registered
2008-12-12
Start date
2008-12-31
Completion date
2009-01-31
Last updated
2011-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dehydration

Keywords

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

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.

Interventions

DRUGhylenex-facilitated subcutaneous Lactated Ringer's infusion

single subcutaneous 150 U dose of hylenex, followed by subcutaneous infusion of 1000 mL Lactated Ringer's solution

Sponsors

Halozyme Therapeutics
CollaboratorINDUSTRY
Baxter Healthcare Corporation
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Technical Challengesthroughout 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

MeasureTime frame
Attempts Needed to Successfully Place Subcutaneous Catheter/Buttonfrom start of first attempt until completion of catheter/button placement
Time Needed to Successfully Place Subcutaneous Catheter/Buttonfrom start of first attempt until completion of catheter/button placement
Time Required to Infuse 1000 mL Fluidfrom start of Lactated Ringer's (LR) infusion until 1000 mL LR infused

Countries

United States

Participant flow

Participants by arm

ArmCount
Tegaderm-secured 24 ga Teflon Catheter10
Tape-secured 24 ga Teflon Catheter11
Tegaderm-secured 24 ga Polyurethane Catheter11
Tape-secured 24 ga Polyurethane Catheter10
Tegaderm-secured 20 ga Teflon Catheter12
Tape-secured 20 ga Teflon Catheter12
Tegaderm-secured 20 ga Polyurethane Catheter12
Tape-secured 20 ga Polyurethane Catheter11
SC Button With 27 ga X 9 mm Needle11
Total100

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003FG004FG005FG006FG007FG008
Overall StudyLost to Follow-up000001000

Baseline characteristics

CharacteristicSC Button With 27 ga X 9 mm NeedleTape-secured 20 ga Polyurethane CatheterTegaderm-secured 20 ga Polyurethane CatheterTape-secured 20 ga Teflon CatheterTegaderm-secured 20 ga Teflon CatheterTape-secured 24 ga Polyurethane CatheterTegaderm-secured 24 ga Polyurethane CatheterTape-secured 24 ga Teflon CatheterTegaderm-secured 24 ga Teflon CatheterTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
11 Participants11 Participants12 Participants12 Participants12 Participants10 Participants11 Participants11 Participants10 Participants100 Participants
Age Continuous36.6 years
STANDARD_DEVIATION 12.3
32.4 years
STANDARD_DEVIATION 12.7
33.6 years
STANDARD_DEVIATION 10.7
34.3 years
STANDARD_DEVIATION 10.3
34.0 years
STANDARD_DEVIATION 12.5
35.3 years
STANDARD_DEVIATION 10.9
33.8 years
STANDARD_DEVIATION 10.4
36.0 years
STANDARD_DEVIATION 10.6
34.6 years
STANDARD_DEVIATION 9.39
34.5 years
STANDARD_DEVIATION 10.8
Region of Enrollment
United States
11 participants11 participants12 participants12 participants12 participants10 participants11 participants11 participants10 participants100 participants
Sex: Female, Male
Female
5 Participants4 Participants5 Participants6 Participants3 Participants3 Participants8 Participants1 Participants3 Participants38 Participants
Sex: Female, Male
Male
6 Participants7 Participants7 Participants6 Participants9 Participants7 Participants3 Participants10 Participants7 Participants62 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
EG006
affected / at risk
EG007
affected / at risk
EG008
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —— / —— / —— / —— / —— / —— / —
other
Total, other adverse events
6 / 105 / 119 / 117 / 109 / 1210 / 1210 / 1210 / 118 / 11
serious
Total, serious adverse events
0 / 100 / 110 / 110 / 101 / 120 / 120 / 120 / 110 / 11

Outcome results

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

Time frame: throughout subcutaneous hylenex and fluid administration period (continuous)

Population: ITT (all treated subjects)

ArmMeasureGroupValue (NUMBER)
Tegaderm-secured 24 ga Teflon CatheterTechnical ChallengesSubjects with 2 Technical Challenges0 participants
Tegaderm-secured 24 ga Teflon CatheterTechnical ChallengesSubjects with Catheter Dislodgement0 participants
Tegaderm-secured 24 ga Teflon CatheterTechnical ChallengesSubjects with Infusion Pump Alarm2 participants
Tegaderm-secured 24 ga Teflon CatheterTechnical ChallengesSubjects with at Least One Technical Challenge2 participants
Tegaderm-secured 24 ga Teflon CatheterTechnical ChallengesSubjects with 3 Technical Challenges0 participants
Tegaderm-secured 24 ga Teflon CatheterTechnical ChallengesSubjects with No Technical Challenges8 participants
Tegaderm-secured 24 ga Teflon CatheterTechnical ChallengesSubjects with Catheter Pulled Out0 participants
Tegaderm-secured 24 ga Teflon CatheterTechnical ChallengesSubjects with Catheter Kinking0 participants
Tegaderm-secured 24 ga Teflon CatheterTechnical ChallengesSubjects with Infusion Pump Failure0 participants
Tegaderm-secured 24 ga Teflon CatheterTechnical ChallengesSubjects with 1 TEchnical Challenge2 participants
Tape-secured 24 ga Teflon CatheterTechnical ChallengesSubjects with Catheter Kinking1 participants
Tape-secured 24 ga Teflon CatheterTechnical ChallengesSubjects with 1 TEchnical Challenge3 participants
Tape-secured 24 ga Teflon CatheterTechnical ChallengesSubjects with Infusion Pump Failure0 participants
Tape-secured 24 ga Teflon CatheterTechnical ChallengesSubjects with No Technical Challenges8 participants
Tape-secured 24 ga Teflon CatheterTechnical ChallengesSubjects with Infusion Pump Alarm2 participants
Tape-secured 24 ga Teflon CatheterTechnical ChallengesSubjects with Catheter Dislodgement0 participants
Tape-secured 24 ga Teflon CatheterTechnical ChallengesSubjects with at Least One Technical Challenge3 participants
Tape-secured 24 ga Teflon CatheterTechnical ChallengesSubjects with 3 Technical Challenges0 participants
Tape-secured 24 ga Teflon CatheterTechnical ChallengesSubjects with 2 Technical Challenges0 participants
Tape-secured 24 ga Teflon CatheterTechnical ChallengesSubjects with Catheter Pulled Out0 participants
Tegaderm-secured 24 ga Polyurethane CatheterTechnical ChallengesSubjects with 2 Technical Challenges0 participants
Tegaderm-secured 24 ga Polyurethane CatheterTechnical ChallengesSubjects with Catheter Dislodgement0 participants
Tegaderm-secured 24 ga Polyurethane CatheterTechnical ChallengesSubjects with Infusion Pump Failure0 participants
Tegaderm-secured 24 ga Polyurethane CatheterTechnical ChallengesSubjects with No Technical Challenges9 participants
Tegaderm-secured 24 ga Polyurethane CatheterTechnical ChallengesSubjects with 1 TEchnical Challenge2 participants
Tegaderm-secured 24 ga Polyurethane CatheterTechnical ChallengesSubjects with at Least One Technical Challenge2 participants
Tegaderm-secured 24 ga Polyurethane CatheterTechnical ChallengesSubjects with Infusion Pump Alarm2 participants
Tegaderm-secured 24 ga Polyurethane CatheterTechnical ChallengesSubjects with Catheter Pulled Out0 participants
Tegaderm-secured 24 ga Polyurethane CatheterTechnical ChallengesSubjects with 3 Technical Challenges0 participants
Tegaderm-secured 24 ga Polyurethane CatheterTechnical ChallengesSubjects with Catheter Kinking0 participants
Tape-secured 24 ga Polyurethane CatheterTechnical ChallengesSubjects with No Technical Challenges8 participants
Tape-secured 24 ga Polyurethane CatheterTechnical ChallengesSubjects with Catheter Kinking2 participants
Tape-secured 24 ga Polyurethane CatheterTechnical ChallengesSubjects with 3 Technical Challenges1 participants
Tape-secured 24 ga Polyurethane CatheterTechnical ChallengesSubjects with Catheter Pulled Out0 participants
Tape-secured 24 ga Polyurethane CatheterTechnical ChallengesSubjects with at Least One Technical Challenge2 participants
Tape-secured 24 ga Polyurethane CatheterTechnical ChallengesSubjects with Catheter Dislodgement1 participants
Tape-secured 24 ga Polyurethane CatheterTechnical ChallengesSubjects with 2 Technical Challenges0 participants
Tape-secured 24 ga Polyurethane CatheterTechnical ChallengesSubjects with Infusion Pump Failure0 participants
Tape-secured 24 ga Polyurethane CatheterTechnical ChallengesSubjects with 1 TEchnical Challenge1 participants
Tape-secured 24 ga Polyurethane CatheterTechnical ChallengesSubjects with Infusion Pump Alarm1 participants
Tegaderm-secured 20 ga Teflon CatheterTechnical ChallengesSubjects with Infusion Pump Failure0 participants
Tegaderm-secured 20 ga Teflon CatheterTechnical ChallengesSubjects with at Least One Technical Challenge2 participants
Tegaderm-secured 20 ga Teflon CatheterTechnical ChallengesSubjects with 2 Technical Challenges0 participants
Tegaderm-secured 20 ga Teflon CatheterTechnical ChallengesSubjects with No Technical Challenges10 participants
Tegaderm-secured 20 ga Teflon CatheterTechnical ChallengesSubjects with Catheter Pulled Out0 participants
Tegaderm-secured 20 ga Teflon CatheterTechnical ChallengesSubjects with Catheter Kinking0 participants
Tegaderm-secured 20 ga Teflon CatheterTechnical ChallengesSubjects with Infusion Pump Alarm2 participants
Tegaderm-secured 20 ga Teflon CatheterTechnical ChallengesSubjects with 3 Technical Challenges0 participants
Tegaderm-secured 20 ga Teflon CatheterTechnical ChallengesSubjects with Catheter Dislodgement0 participants
Tegaderm-secured 20 ga Teflon CatheterTechnical ChallengesSubjects with 1 TEchnical Challenge2 participants
Tape-secured 20 ga Teflon CatheterTechnical ChallengesSubjects with 2 Technical Challenges0 participants
Tape-secured 20 ga Teflon CatheterTechnical ChallengesSubjects with at Least One Technical Challenge2 participants
Tape-secured 20 ga Teflon CatheterTechnical ChallengesSubjects with No Technical Challenges10 participants
Tape-secured 20 ga Teflon CatheterTechnical ChallengesSubjects with 1 TEchnical Challenge2 participants
Tape-secured 20 ga Teflon CatheterTechnical ChallengesSubjects with 3 Technical Challenges0 participants
Tape-secured 20 ga Teflon CatheterTechnical ChallengesSubjects with Catheter Kinking0 participants
Tape-secured 20 ga Teflon CatheterTechnical ChallengesSubjects with Catheter Dislodgement0 participants
Tape-secured 20 ga Teflon CatheterTechnical ChallengesSubjects with Catheter Pulled Out0 participants
Tape-secured 20 ga Teflon CatheterTechnical ChallengesSubjects with Infusion Pump Alarm2 participants
Tape-secured 20 ga Teflon CatheterTechnical ChallengesSubjects with Infusion Pump Failure0 participants
Tegaderm-secured 20 ga Polyurethane CatheterTechnical ChallengesSubjects with Infusion Pump Failure0 participants
Tegaderm-secured 20 ga Polyurethane CatheterTechnical ChallengesSubjects with No Technical Challenges9 participants
Tegaderm-secured 20 ga Polyurethane CatheterTechnical ChallengesSubjects with 3 Technical Challenges0 participants
Tegaderm-secured 20 ga Polyurethane CatheterTechnical ChallengesSubjects with at Least One Technical Challenge3 participants
Tegaderm-secured 20 ga Polyurethane CatheterTechnical ChallengesSubjects with 1 TEchnical Challenge3 participants
Tegaderm-secured 20 ga Polyurethane CatheterTechnical ChallengesSubjects with Catheter Pulled Out0 participants
Tegaderm-secured 20 ga Polyurethane CatheterTechnical ChallengesSubjects with 2 Technical Challenges0 participants
Tegaderm-secured 20 ga Polyurethane CatheterTechnical ChallengesSubjects with Catheter Kinking0 participants
Tegaderm-secured 20 ga Polyurethane CatheterTechnical ChallengesSubjects with Infusion Pump Alarm3 participants
Tegaderm-secured 20 ga Polyurethane CatheterTechnical ChallengesSubjects with Catheter Dislodgement0 participants
Tape-secured 20 ga Polyurethane CatheterTechnical ChallengesSubjects with Infusion Pump Alarm1 participants
Tape-secured 20 ga Polyurethane CatheterTechnical ChallengesSubjects with at Least One Technical Challenge2 participants
Tape-secured 20 ga Polyurethane CatheterTechnical ChallengesSubjects with Catheter Kinking2 participants
Tape-secured 20 ga Polyurethane CatheterTechnical ChallengesSubjects with Catheter Pulled Out1 participants
Tape-secured 20 ga Polyurethane CatheterTechnical ChallengesSubjects with 3 Technical Challenges0 participants
Tape-secured 20 ga Polyurethane CatheterTechnical ChallengesSubjects with 1 TEchnical Challenge0 participants
Tape-secured 20 ga Polyurethane CatheterTechnical ChallengesSubjects with Catheter Dislodgement0 participants
Tape-secured 20 ga Polyurethane CatheterTechnical ChallengesSubjects with No Technical Challenges9 participants
Tape-secured 20 ga Polyurethane CatheterTechnical ChallengesSubjects with Infusion Pump Failure0 participants
Tape-secured 20 ga Polyurethane CatheterTechnical ChallengesSubjects with 2 Technical Challenges2 participants
SC Button With 27 ga X 9 mm NeedleTechnical ChallengesSubjects with Infusion Pump Failure0 participants
SC Button With 27 ga X 9 mm NeedleTechnical ChallengesSubjects with Catheter Dislodgement0 participants
SC Button With 27 ga X 9 mm NeedleTechnical ChallengesSubjects with 2 Technical Challenges0 participants
SC Button With 27 ga X 9 mm NeedleTechnical ChallengesSubjects with Catheter Pulled Out0 participants
SC Button With 27 ga X 9 mm NeedleTechnical ChallengesSubjects with 1 TEchnical Challenge3 participants
SC Button With 27 ga X 9 mm NeedleTechnical ChallengesSubjects with No Technical Challenges8 participants
SC Button With 27 ga X 9 mm NeedleTechnical ChallengesSubjects with Infusion Pump Alarm3 participants
SC Button With 27 ga X 9 mm NeedleTechnical ChallengesSubjects with 3 Technical Challenges0 participants
SC Button With 27 ga X 9 mm NeedleTechnical ChallengesSubjects with at Least One Technical Challenge3 participants
SC Button With 27 ga X 9 mm NeedleTechnical ChallengesSubjects with Catheter Kinking0 participants
Secondary

Attempts Needed to Successfully Place Subcutaneous Catheter/Button

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

Population: ITT (all treated subjects)

ArmMeasureGroupValue (NUMBER)
Tegaderm-secured 24 ga Teflon CatheterAttempts Needed to Successfully Place Subcutaneous Catheter/Button2 Attempts0 participants
Tegaderm-secured 24 ga Teflon CatheterAttempts Needed to Successfully Place Subcutaneous Catheter/Button1 Attempt10 participants
Tape-secured 24 ga Teflon CatheterAttempts Needed to Successfully Place Subcutaneous Catheter/Button2 Attempts0 participants
Tape-secured 24 ga Teflon CatheterAttempts Needed to Successfully Place Subcutaneous Catheter/Button1 Attempt11 participants
Tegaderm-secured 24 ga Polyurethane CatheterAttempts Needed to Successfully Place Subcutaneous Catheter/Button1 Attempt10 participants
Tegaderm-secured 24 ga Polyurethane CatheterAttempts Needed to Successfully Place Subcutaneous Catheter/Button2 Attempts1 participants
Tape-secured 24 ga Polyurethane CatheterAttempts Needed to Successfully Place Subcutaneous Catheter/Button2 Attempts0 participants
Tape-secured 24 ga Polyurethane CatheterAttempts Needed to Successfully Place Subcutaneous Catheter/Button1 Attempt10 participants
Tegaderm-secured 20 ga Teflon CatheterAttempts Needed to Successfully Place Subcutaneous Catheter/Button1 Attempt12 participants
Tegaderm-secured 20 ga Teflon CatheterAttempts Needed to Successfully Place Subcutaneous Catheter/Button2 Attempts0 participants
Tape-secured 20 ga Teflon CatheterAttempts Needed to Successfully Place Subcutaneous Catheter/Button1 Attempt11 participants
Tape-secured 20 ga Teflon CatheterAttempts Needed to Successfully Place Subcutaneous Catheter/Button2 Attempts1 participants
Tegaderm-secured 20 ga Polyurethane CatheterAttempts Needed to Successfully Place Subcutaneous Catheter/Button2 Attempts0 participants
Tegaderm-secured 20 ga Polyurethane CatheterAttempts Needed to Successfully Place Subcutaneous Catheter/Button1 Attempt12 participants
Tape-secured 20 ga Polyurethane CatheterAttempts Needed to Successfully Place Subcutaneous Catheter/Button1 Attempt11 participants
Tape-secured 20 ga Polyurethane CatheterAttempts Needed to Successfully Place Subcutaneous Catheter/Button2 Attempts0 participants
SC Button With 27 ga X 9 mm NeedleAttempts Needed to Successfully Place Subcutaneous Catheter/Button2 Attempts0 participants
SC Button With 27 ga X 9 mm NeedleAttempts Needed to Successfully Place Subcutaneous Catheter/Button1 Attempt11 participants
Secondary

Time Needed to Successfully Place Subcutaneous Catheter/Button

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

Population: ITT (all treated subjects)

ArmMeasureValue (MEDIAN)
Tegaderm-secured 24 ga Teflon CatheterTime Needed to Successfully Place Subcutaneous Catheter/Button23 seconds
Tape-secured 24 ga Teflon CatheterTime Needed to Successfully Place Subcutaneous Catheter/Button43 seconds
Tegaderm-secured 24 ga Polyurethane CatheterTime Needed to Successfully Place Subcutaneous Catheter/Button30 seconds
Tape-secured 24 ga Polyurethane CatheterTime Needed to Successfully Place Subcutaneous Catheter/Button34 seconds
Tegaderm-secured 20 ga Teflon CatheterTime Needed to Successfully Place Subcutaneous Catheter/Button30 seconds
Tape-secured 20 ga Teflon CatheterTime Needed to Successfully Place Subcutaneous Catheter/Button49 seconds
Tegaderm-secured 20 ga Polyurethane CatheterTime Needed to Successfully Place Subcutaneous Catheter/Button31 seconds
Tape-secured 20 ga Polyurethane CatheterTime Needed to Successfully Place Subcutaneous Catheter/Button15 seconds
SC Button With 27 ga X 9 mm NeedleTime Needed to Successfully Place Subcutaneous Catheter/Button9 seconds
Secondary

Time Required to Infuse 1000 mL Fluid

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

Population: ITT (all treated subjects)

ArmMeasureValue (MEAN)Dispersion
Tegaderm-secured 24 ga Teflon CatheterTime Required to Infuse 1000 mL Fluid6.82 hoursStandard Deviation 0.058
Tape-secured 24 ga Teflon CatheterTime Required to Infuse 1000 mL Fluid6.78 hoursStandard Deviation 0.098
Tegaderm-secured 24 ga Polyurethane CatheterTime Required to Infuse 1000 mL Fluid6.81 hoursStandard Deviation 0.013
Tape-secured 24 ga Polyurethane CatheterTime Required to Infuse 1000 mL Fluid6.80 hoursStandard Deviation 0.114
Tegaderm-secured 20 ga Teflon CatheterTime Required to Infuse 1000 mL Fluid6.78 hoursStandard Deviation 0.071
Tape-secured 20 ga Teflon CatheterTime Required to Infuse 1000 mL Fluid6.80 hoursStandard Deviation 0.013
Tegaderm-secured 20 ga Polyurethane CatheterTime Required to Infuse 1000 mL Fluid6.81 hoursStandard Deviation 0.078
Tape-secured 20 ga Polyurethane CatheterTime Required to Infuse 1000 mL Fluid6.79 hoursStandard Deviation 0.108
SC Button With 27 ga X 9 mm NeedleTime Required to Infuse 1000 mL Fluid6.82 hoursStandard Deviation 0.078

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026