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

Dehydration Clinical Trial

— Hylenex  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01139294
• Other study ID #: 091087
• Secondary ID: Clinical Trial
• Status: Completed
• Phase: Phase 4
• First received: June 4, 2010
• Last updated: January 8, 2018
• Start date: February 2010
• Est. completion date: November 2011

Study information

• Verified date: January 2018
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Months to 3 Years

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

Related Conditions & MeSH terms

• Cardiac Output
• Dehydration
• Pediatrics

Intervention

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

Locations

Country	Name	City	State
United States	Monroe Carell Jr. Children's Hospital at Vanderbilt	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	Baxter Healthcare Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.