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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01139294
Recruitment Status : Completed
First Posted : June 8, 2010
Results First Posted : June 26, 2017
Last Update Posted : February 1, 2018
Baxter Healthcare Corporation
Information provided by (Responsible Party):
Thomas Abramo, Vanderbilt University Medical Center

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.

Condition or disease Intervention/treatment Phase
Dehydration Cardiac Output Pediatrics Drug: Hylenex Phase 4

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  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Phase IV Randomized Study of Hylenex or Standard IV Hydration in the Pediatric Population With Moderate Dehydration
Study Start Date : February 2010
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

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 Name: hyaluronidase human injection

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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. ]

    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

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Ages Eligible for Study:   2 Months to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01139294

United States, Tennessee
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, United States, 37232-9001
Sponsors and Collaborators
Vanderbilt University Medical Center
Baxter Healthcare Corporation
Principal Investigator: Thomas J Abramo, MD Monroe Carell Jr. Children's Hospital at Vanderbilt

Responsible Party: Thomas Abramo, Professor, Vanderbilt University Medical Center Identifier: NCT01139294     History of Changes
Other Study ID Numbers: 091087
Clinical Trial ( Other Grant/Funding Number: Baxter )
First Posted: June 8, 2010    Key Record Dates
Results First Posted: June 26, 2017
Last Update Posted: February 1, 2018
Last Verified: January 2018

Keywords provided by Thomas Abramo, Vanderbilt University Medical Center:
cardiac output

Additional relevant MeSH terms:
Water-Electrolyte Imbalance
Metabolic Diseases
Pathologic Processes