Descriptive Study of Cardiac Output During Rehydration With Recombinant Human Hyaluronidase in Pediatrics

Phase 4

Completed

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Hylenex	Hylenex	1ml subcutaneous with initiation of intravenous fluids then every 24 hours with a maximum dose of 3 injections in 72 hours

Primary Outcome Measures

Name	Time	Method
Cardiac Output Trends	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

Secondary Outcome Measures

Name	Time	Method
Gorelick Assessment	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.	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