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NCT01139294 · ClinicalTrials.gov registry record · Phase 4

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

A Phase 4 study, sponsored by Vanderbilt University Medical Center.

Completed
Registry status
Phase 4
Development phase
17
Enrollment target

NCT01139294: Completed Phase 4 study, sponsored by Vanderbilt University Medical Center.

NCT01139294 is a Phase 4 study that has completed, run by Vanderbilt University Medical Center. The registered enrollment target is 17 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01139294, a Phase 4 study, has completed, sponsored by Vanderbilt University Medical Center.

COMPLETED
Registry status
Phase 4
Development phase
17 participants
Enrollment target

Study 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.

Primary Outcome

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

Interventions

  • DRUG Hylenex

Trial Details

FieldValue
Enrollment Target 17 participants
Start Date 2010-02
Est. Completion 2011-11
Phase Phase 4

What the finished NCT01139294 record still lists

NCT01139294 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).

The record links to 0 conditions, and to 1 intervention - of which Hylenex is the first listed.

NCT01139294 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01139294 about?

NCT01139294 is a clinical study titled "Descriptive Study of Cardiac Output During Rehydration With Recombinant Human Hyaluronidase in Pediatrics". 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 ...

What is the current status of trial NCT01139294?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 17 participants. The study started on 2010-02. Estimated completion is 2011-11.

What interventions are being tested in trial NCT01139294?

The interventions under investigation include: Hylenex (DRUG).

Who is sponsoring clinical trial NCT01139294?

This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01139294's enrollment target sits among peer trials

17 1854th of 2000 higher than 132 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01139294, the US trial registry maintained by the National Library of Medicine. NCT01139294 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.