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

NCT ID: NCT01139294

Last Updated: 2018-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2011-11-30

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.

Conditions

Dehydration; Cardiac Output; Pediatrics

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

standard IV therapy

control arm of the study

Group Type: NO_INTERVENTION

No interventions assigned to this group

Hylenex

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

Group Type: EXPERIMENTAL

Hylenex

Intervention Type: DRUG

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

Interventions

Hylenex

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

Intervention Type: DRUG

Other Intervention Names

hyaluronidase human injection

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

• Minimum Eligible Age: 2 Months
• Maximum Eligible Age: 3 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Baxter Healthcare Corporation

INDUSTRY

Sponsor Role: collaborator

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Thomas Abramo

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thomas J Abramo, MD

Role: PRINCIPAL_INVESTIGATOR

Monroe Carell Jr. Children's Hospital at Vanderbilt

Locations

Monroe Carell Jr. Children's Hospital at Vanderbilt

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

Clinical Trial

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

091087

Identifier Type: -

Identifier Source: org_study_id