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

Primary Purpose

Dehydration, Cardiac Output, Pediatrics

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Hylenex

About this trial

This is an interventional other trial for Dehydration focused on measuring cardiac output, dehydration, pediatrics

Eligibility Criteria

2 Months - 3 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Monroe Carell Jr. Children's Hospital at Vanderbilt

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

standard IV therapy

Hylenex

Arm Description

control arm of the study

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT01139294

First Posted

June 4, 2010

Last Updated

January 8, 2018

Sponsor

Vanderbilt University Medical Center

Collaborators

Baxter Healthcare Corporation

1. Study Identification

Unique Protocol Identification Number

NCT01139294

Brief Title

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

Acronym

Hylenex

Official Title

Phase IV Randomized Study of Hylenex or Standard IV Hydration in the Pediatric Population With Moderate Dehydration

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Completed

Study Start Date

February 2010 (undefined)

Primary Completion Date

November 2011 (Actual)

Study Completion Date

November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Vanderbilt University Medical Center

Collaborators

Baxter Healthcare Corporation

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dehydration, Cardiac Output, Pediatrics

Keywords

cardiac output, dehydration, pediatrics

7. Study Design

Primary Purpose

Other

Study Phase

Phase 4

Interventional Study Model

Factorial Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

17 (Actual)

8. Arms, Groups, and Interventions

Arm Title

standard IV therapy

Arm Type

No Intervention

Arm Description

control arm of the study

Arm Title

Hylenex

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Hylenex

Other Intervention Name(s)

hyaluronidase human injection

Intervention Description

1ml subcutaneous with initiation of intravenous fluids then every 24 hrs with a maximum dose of 3 injections in 72 hours

Primary Outcome Measure Information:

Title

Cardiac Output Trends

Description

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.

Secondary Outcome Measure Information:

Title

Gorelick Assessment

Description

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Months

Maximum Age & Unit of Time

3 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thomas J Abramo, MD

Organizational Affiliation

Monroe Carell Jr. Children's Hospital at Vanderbilt

Official's Role

Principal Investigator

Facility Information:

Facility Name

Monroe Carell Jr. Children's Hospital at Vanderbilt

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232-9001

Country

United States

12. IPD Sharing Statement

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

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