DehydrationPhase 4INFUSE-ATNCT00807885

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

A Phase 4 study testing hylenex-facilitated subcutaneous Lactated Ringer's infusion in people with Dehydration, run by Baxter Healthcare Corporation at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Dehydration
What is being tested?: hylenex-facilitated subcutaneous Lactated Ringer's infusion
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 2 sitesUnited States
Study dates: Dec 2008to Jan 2009
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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 locations and contacts

2 sites in 1 country.

United States2 sites

MDS Pharma Services
Lincoln, Nebraska, 68502
MDS Pharma Services
Neptune City, New Jersey, 07753

Other trials in United States

About this study

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

Conditions: Dehydration
Being tested: hylenex-facilitated subcutaneous Lactated Ringer's infusion
Keywords: dehydration, fluid therapy, hyaluronoglucosaminidase, hyaluronidase, hypodermoclysis, clysis, subcutaneous hydration, subcutaneous rehydration, hyaluronan, rHuPH20
Medical subject headings: Dehydration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

hylenex-facilitated subcutaneous Lactated Ringer's infusionDrug
Also called hylenex, rHuPH20, LR, LR solution
single subcutaneous 150 U dose of hylenex, followed by subcutaneous infusion of 1000 mL Lactated Ringer's solution

Study groups in NCT00807885
Study group	Role	What they receive
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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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) Receives: Drug: hylenex-facilitated subcutaneous Lactated Ringer's infusion

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: throughout subcutaneous hylenex and fluid administration period (continuous)

Secondary outcomes (3)

Attempts Needed to Successfully Place Subcutaneous Catheter/Button
Measured: from start of first attempt until completion of catheter/button placement
Time Needed to Successfully Place Subcutaneous Catheter/Button
Measured: from start of first attempt until completion of catheter/button placement
Time Required to Infuse 1000 mL Fluid
Measured: from start of Lactated Ringer's (LR) infusion until 1000 mL LR infused

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2008Jan 2009

First posted12 Dec 2008 (estimated)
Study startDec 2008
Primary completionJan 2009
Study completionJan 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for DehydrationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00807885
Sponsor's protocol ID: 1838-007
Acronym: INFUSE-AT
Status last verified: Oct 2011
First submitted: 10 Dec 2008
Last updated: 26 Oct 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Dehydrated, Water-Electrolyte Imbalance, Malnutrition, Dehydration (Physiology)
Not yet recruitingPhase 2
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Cholera (Disorder)
Recruiting
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Recruiting
Hydration & Female Life Stages
Dehydration, Menstruation
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All Dehydration trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00807885
Acronym / sponsor ID: INFUSE-AT / 1838-007
Conditions: Dehydration
Keywords: dehydration, fluid therapy, hyaluronoglucosaminidase, hyaluronidase, hypodermoclysis, clysis, subcutaneous hydration, subcutaneous rehydration
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Baxter Healthcare CorporationIndustry (pharma, biotech, devices)
Collaborators: Halozyme Therapeutics
Study start: Dec 2008
Primary completion: Jan 2009 (actual)
Study completion: Jan 2009 (actual)
First posted: 12 Dec 2008 (estimated)
Results: Posted 18 Oct 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 9

Arm	Type	Receives
Tegaderm-secured 24 ga Teflon catheter	Experimental	Drug: hylenex-facilitated subcutaneous Lactated Ringer's infusionsubcutaneous 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
Tape-secured 24 ga Teflon catheter	Experimental	Drug: hylenex-facilitated subcutaneous Lactated Ringer's infusionsubcutaneous 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
Tegaderm-secured 24 ga polyurethane catheter	Experimental	Drug: hylenex-facilitated subcutaneous Lactated Ringer's infusionsubcutaneous 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
Tape-secured 24 ga polyurethane catheter	Experimental	Drug: hylenex-facilitated subcutaneous Lactated Ringer's infusionsubcutaneous 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
Tegaderm-secured 20 ga Teflon catheter	Experimental	Drug: hylenex-facilitated subcutaneous Lactated Ringer's infusionsubcutaneous 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
Tape-secured 20 ga Teflon catheter	Experimental	Drug: hylenex-facilitated subcutaneous Lactated Ringer's infusionsubcutaneous 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
Tegaderm-secured 20 ga polyurethane catheter	Experimental	Drug: hylenex-facilitated subcutaneous Lactated Ringer's infusionsubcutaneous 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
Tape-secured 20 ga polyurethane catheter	Experimental	Drug: hylenex-facilitated subcutaneous Lactated Ringer's infusionsubcutaneous 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
SC button with 27 ga X 9 mm needle	Experimental	Drug: hylenex-facilitated subcutaneous Lactated Ringer's infusionsubcutaneous 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)

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (8 listed)

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

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
hylenex-facilitated subcutaneous Lactated Ringer's infusionAlso: hylenex, rHuPH20, LR, LR solutionsingle subcutaneous 150 U dose of hylenex, followed by subcutaneous infusion of 1000 mL Lactated Ringer's solution	Drug	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

Primary outcome

Technical Challenges
Time frame: throughout 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

3 secondary outcomes

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

Results and safety

Results posted to the registry on 18 Oct 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Tegaderm-secured 24 ga Teflon Catheter	10	10
Tape-secured 24 ga Teflon Catheter	11	11
Tegaderm-secured 24 ga Polyurethane Catheter	11	11
Tape-secured 24 ga Polyurethane Catheter	10	10
Tegaderm-secured 20 ga Teflon Catheter	12	12
Tape-secured 20 ga Teflon Catheter	12	11
Tegaderm-secured 20 ga Polyurethane Catheter	12	12
Tape-secured 20 ga Polyurethane Catheter	11	11
SC Button With 27 ga X 9 mm Needle	11	11

Primary outcome: Technical Challenges

Time frame: throughout subcutaneous hylenex and fluid administration period (continuous). Number. Unit: participants

Measure	Tegaderm-secured 24 ga Teflon Catheter n = 10	Tape-secured 24 ga Teflon Catheter n = 11	Tegaderm-secured 24 ga Polyurethane Catheter n = 11	Tape-secured 24 ga Polyurethane Catheter n = 10	Tegaderm-secured 20 ga Teflon Catheter n = 12	Tape-secured 20 ga Teflon Catheter n = 12	Tegaderm-secured 20 ga Polyurethane Catheter n = 12	Tape-secured 20 ga Polyurethane Catheter n = 11	SC Button With 27 ga X 9 mm Needle n = 11
Subjects with at Least One Technical Challenge	2	3	2	2	2	2	3	2	3
Subjects with No Technical Challenges	8	8	9	8	10	10	9	9	8
Subjects with 1 TEchnical Challenge	2	3	2	1	2	2	3	0	3
Subjects with 2 Technical Challenges	0	0	0	0	0	0	0	2	0
Subjects with 3 Technical Challenges	0	0	0	1	0	0	0	0	0
Subjects with Catheter Kinking	0	1	0	2	0	0	0	2	0
Subjects with Catheter Dislodgement	0	0	0	1	0	0	0	0	0
Subjects with Catheter Pulled Out	0	0	0	0	0	0	0	1	0

Population analysed: ITT (all treated subjects)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 d post-treatment. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tegaderm-secured 24 ga Teflon Catheter	0 of 10 (0%)	6 of 10 (60%)	Not reported
Tape-secured 24 ga Teflon Catheter	0 of 11 (0%)	5 of 11 (45.5%)	Not reported
Tegaderm-secured 24 ga Polyurethane Catheter	0 of 11 (0%)	9 of 11 (81.8%)	Not reported
Tape-secured 24 ga Polyurethane Catheter	0 of 10 (0%)	7 of 10 (70%)	Not reported
Tegaderm-secured 20 ga Teflon Catheter	1 of 12 (8.3%)	9 of 12 (75%)	Not reported
Tape-secured 20 ga Teflon Catheter	0 of 12 (0%)	10 of 12 (83.3%)	Not reported
Tegaderm-secured 20 ga Polyurethane Catheter	0 of 12 (0%)	10 of 12 (83.3%)	Not reported
Tape-secured 20 ga Polyurethane Catheter	0 of 11 (0%)	10 of 11 (90.9%)	Not reported
SC Button With 27 ga X 9 mm Needle	0 of 11 (0%)	8 of 11 (72.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

George Harb, MD, MPH study director

Baxter Healthcare Corporation

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing hylenex-facilitated subcutaneous Lactated Ringer's infusion in people with Dehydration, run by Baxter Healthcare Corporation at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Oct 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Technical Challenges (time frame: throughout subcutaneous hylenex and fluid administration period (continuous)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00807885.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2011; AzTrials last refreshed its copy on 7 Nov 2026.