DehydrationPhase 4HylenexNCT01139294
Descriptive Study of Cardiac Output During Rehydration With Recombinant Human Hyaluronidase in Pediatrics
A Phase 4 study testing Hylenex in people with Dehydration and Cardiac Output, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to non-invasively study the reflective changes in cardiac output as response to fluid therapy in the pediatric moderate hypovolemia/dehydrated pediatric patients using sub-q rehydration using Hylenex augmented subcutaneous infusion of fluids and electrolytes compared to intravenous methods. Read more about this study
- Who is it for?
- Ages 2 months to 3 yearsHealthy volunteers can take part
- Conditions the study is for
- Dehydration, Cardiac Output, Pediatrics
- What is being tested?
- Hylenex
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Nov 2011
- 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 2 months to 3 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- patients presenting to the Emergency Department (ED) with moderate dehydration (gorelick dehydration classification : presence of 3-6 moderate signs and symptoms) requiring parenteral rehydration.
- Patient has not successfully received oral or IV fluids immediately prior to enrollment
- patient's legally authorized representative has signed the informed consent and is willing for the patient to receive Hylenex augmented sub-q rehydration
Who cannot join
- patient in shock or a life-threatening situation
- immunocompromised, history of abscess or cellulitis, abscess \&/or cellulitis caused by Methicillin-resistant Staphylococcus aureus (MRSA), family history of abscess or cellulitis
- requires IV therapy for another indication
- has an indwelling catheter
- has already received rehydration therapy by IV route within the last 48 hours or substantial oral fluid in the immediate time period of enrollment
- has a condition precluding sub-q injection or infusion site evaluation in the upper middle back area or at another elected site of infusion
Show all 13Show fewer
- has a reason for hospital admission or extended ED stay other than dehydration
- has an known hypersensitivity to hyaluronidase or another ingredient in the formulation of Hylenex
- has a know hyponatremia < 130 milliequivalents per liter (mEq/L) or hypernatremia >155 mEq/L
- has a know hypokalemia <3.0 mEq/L
- has a medical condition likely to interfere with the patients ability to fully complete the study protocol or the ability to have the protocol-specified assessments
- has a medical history, screening physical exam finding or historical clinical lab result that in the opinion of the investigator would preclude the patients safe participation in the is study or which might adversely effect the interpretation of the study results
- patient participated in a study of any investigational drug or device within 230 days prior to enrollment in this study
Trial locations and contacts
1 site in 1 country.
United States1 site
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, 37232-9001
About this study
Official title: Phase IV Randomized Study of Hylenex or Standard IV Hydration in the Pediatric Population With Moderate Dehydration
The purpose of this study is to non-invasively study the reflective changes in cardiac output as response to fluid therapy in the pediatric moderate hypovolemia/dehydrated pediatric patients using sub-q rehydration using Hylenex augmented subcutaneous infusion of fluids and electrolytes compared to intravenous methods.
Read the detailed description
This is an open-labeled, single-center Phase IV clinical trial. The study will consist of patients with moderate hypovolemia/dehydration requiring parenteral rehydration. It is expected that this study will describe the onset or change in cardiac output using Hylenex augmented subcutaneous rehydration from ages 2 months up to 3 years and at a flow rate satisfying clinical needs, especially in reference to changes in cardiac output observed in standard intravenous rehydration.
- Conditions
- Dehydration, Cardiac Output, Pediatrics
- Being tested
- Hylenex
- Keywords
- cardiac output, dehydration, pediatrics
- Medical subject headings
- Dehydration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HylenexDrug
Also called hyaluronidase human injection
1ml subcutaneous with initiation of intravenous fluids then every 24 hrs with a maximum dose of 3 injections in 72 hours
| Study group | Role | What they receive |
|---|---|---|
| standard IV therapy | No intervention | control arm of the study |
| Hylenex | Experimental | 1ml subcutaneous with initiation of intravenous fluids then every 24 hours with a maximum dose of 3 injections in 72 hours Receives: Drug: Hylenex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac Output Trends
Describe the cardiac output trends measured in liters per minute (onset and changes in slope over time) by noninvasively monitoring methods in pediatric patients being rehydrated by Hylenex augmented subcutaneous rehydration or routine IV rehydration
Measured: Measurements and data are recorded only while patient is receiving care in the Emergency Department (ED). A f/u call is made on day 3 and/or day 7 post enrollment into the study.
Secondary outcomes (1)
Gorelick Assessment
Gorelick assessment of hydration status at baseline, and at the end of sub-q or IV hydration treatment or at discharge from the emergency dept.
- volume of fluid infuse over time
- time to discharge from ED to home or transfer into the hospital
- discharge diagnosis from ED
- duration of any supplemental hospitalization for supplemental hydration
- time to first urine output observed
- requirement for rescue therapy and nature of the rescue therapy
- incidence of readmission to hospital/ED
- global assessment of overall satisfaction with rehydration therapy by parents and caregiver
Measured: Measurements and data are recorded only while patient is receiving care in the ED. A f/u call is made on day 3 and/or day 7 post enrollment into the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2010 (estimated)
- Study startFeb 2010
- Primary completionNov 2011
- Study completionNov 2011
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.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Responsible party
- Principal investigator, Thomas Abramo, Vanderbilt University Medical Center
- Investigators
- Thomas J Abramo, MD, Principal investigator, Monroe Carell Jr. Children's Hospital at Vanderbilt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01139294
- Sponsor's protocol ID
- 091087
- Other IDs
- Clinical Trial
- Acronym
- Hylenex
- Status last verified
- Jan 2018
- First submitted
- 4 Jun 2010
- Last updated
- 1 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV Randomized Study of Hylenex or Standard IV Hydration in the Pediatric Population With Moderate Dehydration
- ClinicalTrials.gov ID
- NCT01139294
- Acronym / sponsor ID
- Hylenex / 091087
- Conditions
- Dehydration, Cardiac Output, Pediatrics
- Keywords
- cardiac output, dehydration, pediatrics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Study start
- Feb 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 8 Jun 2010 (estimated)
- Results
- Posted 26 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to non-invasively study the reflective changes in cardiac output as response to fluid therapy in the pediatric moderate hypovolemia/dehydrated pediatric patients using sub-q rehydration using Hylenex augmented subcutaneous infusion of fluids and electrolytes compared to intravenous methods.
Detailed description
This is an open-labeled, single-center Phase IV clinical trial. The study will consist of patients with moderate hypovolemia/dehydration requiring parenteral rehydration. It is expected that this study will describe the onset or change in cardiac output using Hylenex augmented subcutaneous rehydration from ages 2 months up to 3 years and at a flow rate satisfying clinical needs, especially in reference to changes in cardiac output observed in standard intravenous rehydration.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard IV therapy | No intervention | –control arm of the study |
| Hylenex | Experimental | Drug: Hylenex1ml subcutaneous with initiation of intravenous fluids then every 24 hours with a maximum dose of 3 injections in 72 hours |
Who may qualify
- Ages
- 2 months to 3 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- patients presenting to the Emergency Department (ED) with moderate dehydration (gorelick dehydration classification : presence of 3-6 moderate signs and symptoms) requiring parenteral rehydration.
- Patient has not successfully received oral or IV fluids immediately prior to enrollment
- patient's legally authorized representative has signed the informed consent and is willing for the patient to receive Hylenex augmented sub-q rehydration
Key exclusion criteria (13 listed)
- patient in shock or a life-threatening situation
- immunocompromised, history of abscess or cellulitis, abscess \&/or cellulitis caused by Methicillin-resistant Staphylococcus aureus (MRSA), family history of abscess or cellulitis
- requires IV therapy for another indication
- has an indwelling catheter
- has already received rehydration therapy by IV route within the last 48 hours or substantial oral fluid in the immediate time period of enrollment
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 |
|---|---|---|
| HylenexAlso: hyaluronidase human injection1ml subcutaneous with initiation of intravenous fluids then every 24 hrs with a maximum dose of 3 injections in 72 hours | Drug | Hylenex |
Primary outcome
Cardiac Output Trends
Time frame: Measurements and data are recorded only while patient is receiving care in the Emergency Department (ED). A f/u call is made on day 3 and/or day 7 post enrollment into the study.
Describe the cardiac output trends measured in liters per minute (onset and changes in slope over time) by noninvasively monitoring methods in pediatric patients being rehydrated by Hylenex augmented subcutaneous rehydration or routine IV rehydration
1 secondary outcome
Gorelick Assessment
Time frame: Measurements and data are recorded only while patient is receiving care in the ED. A f/u call is made on day 3 and/or day 7 post enrollment into the study.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2018.
- 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.
Thomas J Abramo, MD principal investigator
Monroe Carell Jr. Children's Hospital at Vanderbilt
1 site 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 in people with Dehydration and Cardiac Output, run by Vanderbilt University Medical Center at 1 site 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 3 inclusion and 13 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 1 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 26 Jun 2017). 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?
Cardiac Output Trends (time frame: Measurements and data are recorded only while patient is receiving care in the Emergency Department (ED). A f/u call is made on day 3 and/or day 7 post enrollment into the study.). 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 1 Feb 2018.