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

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.

Study Overview

• Status: Completed
• Conditions: Dehydration; Pediatrics; Cardiac Output
• Intervention / Treatment: Drug: Hylenex

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 Type: Interventional
• Enrollment (Actual): 17
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232-9001
      • Monroe Carell Jr. Children's Hospital at Vanderbilt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 months to 3 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: standard IV therapy; control arm of the study
EXPERIMENTAL: Hylenex; 1ml subcutaneous with initiation of intravenous fluids then every 24 hours with a maximum dose of 3 injections in 72 hours	Drug: Hylenex; 1ml subcutaneous with initiation of intravenous fluids then every 24 hrs with a maximum dose of 3 injections in 72 hours; Other Names: hyaluronidase human injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Collaborators: Baxter Healthcare Corporation
• Investigators: Principal Investigator: Thomas J Abramo, MD, Monroe Carell Jr. Children's Hospital at Vanderbilt

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (ACTUAL): November 1, 2011
• Study Completion (ACTUAL): November 1, 2011

Study Registration Dates

• First Submitted: June 4, 2010
• First Submitted That Met QC Criteria: June 7, 2010
• First Posted (ESTIMATE): June 8, 2010

Study Record Updates

• Last Update Posted (ACTUAL): February 1, 2018
• Last Update Submitted That Met QC Criteria: January 8, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: pediatrics; cardiac output; dehydration
• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Water-Electrolyte Imbalance; Dehydration
• Other Study ID Numbers: 091087; clinical trial (Registry Identifier: Minia University)