This trial is active, not recruiting.

Conditions dehydration, cardiac output, pediatrics
Treatment hyaluronidase human injection
Phase phase 4
Sponsor Vanderbilt University
Collaborator Baxter Healthcare Corporation
Start date February 2010
End date April 2011
Trial size 75 participants
Trial identifier NCT01139294, 091087, Clinical Trial


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model factorial assignment
Masking open label
(No Intervention)
control arm of the study
(Active Comparator)
Patients receiving Hylenex subcutaneous are in the experimental group being compared to the control of standard IV
hyaluronidase human injection Hylenex recombinant
1ml sub-q with initiation of IVF's then every 24 hrs with a max dose of 3 inj. in 72 hours

Primary Outcomes

Cardiac output trends
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.

Secondary Outcomes

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.

Eligibility Criteria

Male or female participants from 2 months up to 3 years old.

Inclusion Criteria: - patients presenting to the 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 Exclusion Criteria: - patient in shock or a life-threatening situation - immunocompromised, history of abscess or cellulitis, abscess &/or cellulitis caused by 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 - 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 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

Additional Information

Official title Phase IV Randomized Study of Hylenex or Standard IV Hydration in the Pediatric Population With Moderate Dehydration
Principal investigator Thomas J Abramo, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2010.
Information provided to ClinicalTrials.gov by Vanderbilt University.