DehydrationPhase 4INFUSE-TMNCT01120431
Efficacy and Time and Resources for Hylenex-facilitated SC Rehydration Versus ORT for Dehydrated Children in the Emergency Department (ED)
A Phase 4 study testing Oral rehydration fluid and Isotonic hydration fluid and recombinant human hyaluronidase in people with Dehydration, run by Baxter Healthcare Corporation.
Trial summary
The purpose is to evaluate the safety and efficacy as well as the time and resources needed in the ED setting to achieve rehydration in young pediatric subjects with mild to moderate dehydration using hylenex-facilitated SC rehydration versus oral rehydration therapy. Read more about this study
- Who is it for?
- Ages 2 months to 2 years
- Conditions the study is for
- Dehydration
- What is being tested?
- Oral rehydration fluid and Isotonic hydration fluid and recombinant human hyaluronidase
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2010to May 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 2 months to 2 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female and aged 2 months to 2 years
- Presenting to ED with mild or moderate dehydration
- Candidate for both parenteral and oral rehydration therapies
- Healthy, except for underlying etiology for dehydration
- Naive to ORT or having received attempted ORT at home for current occurrence of dehydration.
- Pre-dehydration body weight greater than 5th percentile for age
Who cannot join
- Severe dehydration
- Shock or a life-threatening situation
- Any condition precluding SC infusion or infusion site evaluation in all possible anatomical locations (upper back, anterior thighs, abdomen, other potential areas) for SC infusion
- Medical reason or condition precluding administration of ORT
- Indwelling IV catheter (except one intended only for laboratory sample collection) or anticipated need for IV therapy during the study
- Anticipated need for hospitalization(other than for rehydration)
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- Known hypersensitivity to hyaluronidase or any other ingredient in the formulation of hylenex recombinant
- Known hyponatremia, hypernatremia or hypokalemia
- Medical condition likely to interfere with ability to fully complete protocol-specified interventions and assessments, or likely to prolong need for medical attention beyond that required for rehydration
- Participation in an investigational drug or device study within 30 days before participation in this study
About this study
Official title: The INcreased Flow Utilizing Subcutaneously-Enabled Time-Motion (INFUSE-TM) Study: A Randomized, Open-label, Parallel-group, Multicenter Study Evaluating Efficacy and Time and Resources in the Emergency Department for Hylenex-facilitated Subcutaneous Rehydration Versus Oral Rehydration Therapy in Pediatric Patients With Mild to Moderate Dehydration
The purpose is to evaluate the safety and efficacy as well as the time and resources needed in the ED setting to achieve rehydration in young pediatric subjects with mild to moderate dehydration using hylenex-facilitated SC rehydration versus oral rehydration therapy.
- Conditions
- Dehydration
- Being tested
- Oral rehydration fluid, Isotonic hydration fluid and recombinant human hyaluronidase
- Keywords
- dehydration, fluid therapy, hyaluronoglucosaminidase, hyaluronidase, hypodermoclysis, clysis, subcutaneous hydration, subcutaneous rehydration, hyaluronan, rHuPH20, pediatric, ORT
- Medical subject headings
- Dehydration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral rehydration fluidOther
Also called oral rehydration salts
Oral electrolyte solution or other clinically acceptable oral rehydration fluid, 5 to 10 mL of offered with encouragement every 5 to 10 minutes
Isotonic hydration fluid and recombinant human hyaluronidaseDrug
Also called hyelenx, rHuPH20, Lactated Ringer's solution, normal saline solution
Single subcutaneous dose of 150 U recombinant human hyaluronidase, followed by infusion pump-delivered subcutaneous isotonic hydration fluid
| Study group | Role | What they receive |
|---|---|---|
| Oral rehydration therapy | Active comparator | Not described Receives: Other: Oral rehydration fluid |
| hylenex-facilitated SC hydration | Experimental | Not described Receives: Drug: Isotonic hydration fluid and recombinant human hyaluronidase |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total resource utilization in the ED
Measured: 2 to 8 hours
Secondary outcomes (7)
Rate of successful rehydration in the ED
Clinical judgement of adequate hydration, and either: 1) stable or increased body weight or 2) urine production
Measured: 2 to 8 hours
Time to ED discharge
Measured: 2 to 8 hours
Amount of rehydration fluid administered
Measured: 2 to 8 hours
Global satisfaction and ease-of-use assessments by healthcare provider(s) and parent/caregiver
Measured: 2 to 8 hours
Occurrence of infusion site pain or other local reactions
Measured: 2 to 8 hours
Occurrence of other adverse events
Measured: 7 days
Vital signs
Blood pressure, heart rate, respiratory rate, temperature
Measured: 2 to 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2010 (estimated)
- Study startMay 2010 (estimated)
- Primary completionMay 2010 (estimated)
- Study completionMay 2010 (estimated)
Why it stopped: Strategic business decision (not related to safety or efficacy concerns)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baxter Healthcare Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Halozyme Therapeutics
- Responsible party
- Sponsor
- Investigators
- George Harb, MD, MPH, Study director, Baxter Healthcare Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01120431
- Sponsor's protocol ID
- 1838-008
- Acronym
- INFUSE-TM
- Status last verified
- May 2017
- First submitted
- 7 May 2010
- Last updated
- 8 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The INcreased Flow Utilizing Subcutaneously-Enabled Time-Motion (INFUSE-TM) Study: A Randomized, Open-label, Parallel-group, Multicenter Study Evaluating Efficacy and Time and Resources in the Emergency Department for Hylenex-facilitated Subcutaneous Rehydration Versus Oral Rehydration Therapy in Pediatric Patients With Mild to Moderate Dehydration
- ClinicalTrials.gov ID
- NCT01120431
- Acronym / sponsor ID
- INFUSE-TM / 1838-008
- Conditions
- Dehydration
- Keywords
- dehydration, fluid therapy, hyaluronoglucosaminidase, hyaluronidase, hypodermoclysis, clysis, subcutaneous hydration, subcutaneous rehydration
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Strategic business decision (not related to safety or efficacy concerns)
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Baxter Healthcare CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Halozyme Therapeutics
- Study start
- May 2010 (estimated)
- Primary completion
- May 2010 (estimated)
- Study completion
- May 2010 (estimated)
- First posted
- 11 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose is to evaluate the safety and efficacy as well as the time and resources needed in the ED setting to achieve rehydration in young pediatric subjects with mild to moderate dehydration using hylenex-facilitated SC rehydration versus oral rehydration therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral rehydration therapy | Active comparator | Other: Oral rehydration fluid |
| hylenex-facilitated SC hydration | Experimental | Drug: Isotonic hydration fluid and recombinant human hyaluronidase |
Who may qualify
- Ages
- 2 months to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Male or female and aged 2 months to 2 years
- Presenting to ED with mild or moderate dehydration
- Candidate for both parenteral and oral rehydration therapies
- Healthy, except for underlying etiology for dehydration
- Naive to ORT or having received attempted ORT at home for current occurrence of dehydration.
Key exclusion criteria (10 listed)
- Severe dehydration
- Shock or a life-threatening situation
- Any condition precluding SC infusion or infusion site evaluation in all possible anatomical locations (upper back, anterior thighs, abdomen, other potential areas) for SC infusion
- Medical reason or condition precluding administration of ORT
- Indwelling IV catheter (except one intended only for laboratory sample collection) or anticipated need for IV therapy during the study
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 |
|---|---|---|
| Oral rehydration fluidAlso: oral rehydration saltsOral electrolyte solution or other clinically acceptable oral rehydration fluid, 5 to 10 mL of offered with encouragement every 5 to 10 minutes | Other | Oral rehydration therapy |
| Isotonic hydration fluid and recombinant human hyaluronidaseAlso: hyelenx, rHuPH20, Lactated Ringer's solution, normal saline solutionSingle subcutaneous dose of 150 U recombinant human hyaluronidase, followed by infusion pump-delivered subcutaneous isotonic hydration fluid | Drug | hylenex-facilitated SC hydration |
Primary outcome
Total resource utilization in the ED
Time frame: 2 to 8 hours
7 secondary outcomes
Rate of successful rehydration in the ED
Time frame: 2 to 8 hours
Time to ED discharge
Time frame: 2 to 8 hours
Amount of rehydration fluid administered
Time frame: 2 to 8 hours
Global satisfaction and ease-of-use assessments by healthcare provider(s) and parent/caregiver
Time frame: 2 to 8 hours
Occurrence of infusion site pain or other local reactions
Time frame: 2 to 8 hours
Occurrence of other adverse events
Time frame: 7 days
Vital signs
Time frame: 2 to 8 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2017.
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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
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oral rehydration fluid and Isotonic hydration fluid and recombinant human hyaluronidase in people with Dehydration, run by Baxter Healthcare Corporation.
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 6 inclusion and 10 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: withdrawn, as of the sponsor's last update on 8 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Total resource utilization in the ED (time frame: 2 to 8 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 May 2017.