Clinical trial NCT01139294: Descriptive Study of Cardiac Output During Rehydration With Recombinant Human Hyaluronidase in Pediatrics
Official title: Phase IV Randomized Study of Hylenex or Standard IV Hydration in the Pediatric Population With Moderate Dehydration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dehydration
Cardiac Output
Pediatrics
Keywords: cardiac output
dehydration
pediatrics
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: Baxter Healthcare Corporation
First posted: 2010-06-08
Enrollment: 17
Sex: ALL
Minimum age (years): 2
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Cardiac Output Trends
timeFrame: 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:
measure: Gorelick Assessment
timeFrame: 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.
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Monroe Carell Jr. Children's Hospital at Vanderbilt
state: Tennessee
Study officials:
affiliation: Monroe Carell Jr. Children's Hospital at Vanderbilt
name: Thomas J Abramo, MD
role: PRINCIPAL_INVESTIGATOR
References: