NCT01139294

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Vanderbilt University Medical Center · Academic / Other
• Sex: All
• Age: 2 Months – 3 Years
• Healthy volunteers: Accepted

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

Interventions

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

Timeline

• Start date: 2010-02-01
• Primary completion: 2011-11-01
• Completion: 2011-11-01
• First posted: 2010-06-08
• Last updated: 2018-02-01
• Results posted: 2017-06-26

Locations

1 site across 1 country: United States