Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-29 @ 2:00 AM
Study NCT ID:
NCT01139294
Status:
COMPLETED
Last Update Posted:
2018-02-01
First Post:
2010-06-04
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Descriptive Study of Cardiac Output During Rehydration With Recombinant Human Hyaluronidase in Pediatrics
Sponsor:
Vanderbilt University Medical Center
Organization:
Study Overview
Official Title:
Phase IV Randomized Study of Hylenex or Standard IV Hydration in the Pediatric Population With Moderate Dehydration
Status:
COMPLETED
Status Verified Date:
2018-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Hylenex
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| Clinical Trial | OTHER_GRANT | Baxter | View |