Study of Subcutaneous Rehydration With Recombinant Human Hyaluronidase for Infants and Children (INFUSE-PR)

November 22, 2011 updated by: Baxter Healthcare Corporation

INcreased Flow Utilizing Subcutaneously-Enabled Pediatric Rehydration (INFUSE-Pediatric Rehydration Study): Phase IV Study of Subcutaneous Rehydration With Recombinant Human Hyaluronidase (HYLENEX) for Infants and Children

The aim of the study is to evaluate the safety, effectiveness and ease of use of subcutaneous (SC) rehydration using HYLENEX-augmented SC infusion of fluids and electrolytes for the rehydration of pediatric patients with mild to moderate dehydration.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Pediatric patients (2 months to 10 years of age), presenting to the emergency department (ED) with mild to moderate dehydration and requiring parenteral rehydration, were treated with HYLENEX-augmented subcutaneous (SC) rehydration. An initial volume of 20 mL/kg of isotonic fluid was to be administered by continuous SC infusion over the first hour, and additional SC rehydration could be continued as clinically indicated. The preferred anatomic site for the SC infusion was the anterior thigh, unless there was an overriding preference for an alternate site.

The duration of HYLENEX-augmented SC rehydration was to be a minimum of 1 hour and a maximum of 72 hours. The investigator or designee performed a clinical assessment of the subject's hydration status at baseline and at the end of SC infusion or at discharge from the ED. Other assessments of effectiveness and safety were made directly during the rehydration period and ED stay, and by telephone on Days 3 and 7 after discharge from the ED.

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 months to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Child, 2 months to 10 years of age
  • Body weight less than 42 kg
  • Presenting at emergency department with mild to moderate dehydration (Gorelick dehydration classification: presence of 1 to 6 [of possible 10] moderate or severe signs and symptoms) requiring parenteral rehydration

Exclusion Criteria:

  • In shock or life-threatening situation (other than dehydration)
  • Severe dehydration
  • Requires intravenous (IV) therapy for another indication
  • Indwelling IV catheter (excepting one intended strictly for clinical laboratory sample collection)
  • Already received rehydration therapy IV within prior 48 hours or substantial oral fluid immediately before enrollment
  • Condition precluding subcutaneous injection or infusion site evaluation in anterior thigh or other elected infusion site
  • Reason for hospital admission or extended emergency department stay other than dehydration
  • Known hypersensitivity to hyaluronidase or another ingredient in HYLENEX
  • Hyponatremia or hypernatremia
  • Hypokalemia
  • Medical condition likely to interfere with ability to fully complete study or have protocol-specified assessments
  • Medical history, screening examination finding or historical clinical laboratory result precluding safe participation in study or which might adversely effect interpretation of study results
  • Participated in study of any investigational drug or device within 30 days prior to this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HYLENEX-augmented subcutaneous (SC ) rehydration
Single 150 U subcutaneous (SC) HYLENEX dose administered immediately prior to start of SC infusion of rehydration fluid. Additional 150 U HYLENEX dose to be administered prior to any additional fluid infusion beyond 24 hours.
Drug: hyaluronidase (human recombinant)/rehydration fluid
Single 150 U subcutaneous (SC) HYLENEX dose administered immediately prior to start of SC infusion of rehydration fluid. Additional 150 U HYLENEX dose to be administered prior to any additional fluid infusion beyond 24 hours.
Other Names:
  • HYLENEX recombinant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HYLENEX-facilitated Subcutaneous (SC) Rehydration Success
Time Frame: At emergency department discharge (mean time to discharge = 7.03 ± 7.57 hr)
Successfully rehydrated (as medically judged by treating physician) without rescue therapy (ie, without receiving fluids via an alternate route), and discharged to home
At emergency department discharge (mean time to discharge = 7.03 ± 7.57 hr)
Modified HYLENEX-facilitated Subcutaneous (SC) Rehydration Success
Time Frame: At emergency department discharge (mean time to discharge = 7.03 ± 7.57 hr)
Successfully rehydrated (as medically judged by treating physician) without rescue therapy (ie, without receiving fluids via an alternate route), regardless of emergency department discharge destination
At emergency department discharge (mean time to discharge = 7.03 ± 7.57 hr)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Attempts Needed to Successfully Place Subcutaneous (SC) Catheter
Time Frame: At end of placement of SC catheter
At end of placement of SC catheter
Post-treatment Gorelick Dehydration Score
Time Frame: At baseline and at either the end of subcutaneous infusion (mean duration = 5.73 ± 9.15 hr) or emergency department discharge (mean time to discharge = 7.03 ± 7.57 hr)
Score indicates the number of moderate-to-severe signs/symptoms of dehydration, based on assessment of each of the following 10 patient parameters: general condition, quality of radial pulse, quality of respiration, skin elasticity, eyes, tears, mucous membranes, urine output, heart rate and fingertip capillary refill time. Minimum score = 0; maximum score = 10.
At baseline and at either the end of subcutaneous infusion (mean duration = 5.73 ± 9.15 hr) or emergency department discharge (mean time to discharge = 7.03 ± 7.57 hr)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baxter Healthcare Corporation

Collaborators

PPD
Halozyme Therapeutics

Investigators

  • Study Director: George E Harb, MD, Baxter Healthcare Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

May 18, 2007

First Submitted That Met QC Criteria

May 18, 2007

First Posted (Estimate)

May 22, 2007

Study Record Updates

Last Update Posted (Estimate)

December 1, 2011

Last Update Submitted That Met QC Criteria

November 22, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1838-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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