Study of Subcutaneous Rehydration With Recombinant Human Hyaluronidase for Infants and Children - Full Text View

Sponsor:	Baxter Healthcare Corporation
Collaborators:	Halozyme Therapeutics PPD
Information provided by (Responsible Party):	Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:	NCT00477152

Purpose

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.

Condition	Intervention	Phase
Dehydration	Drug: hyaluronidase (human recombinant)/rehydration fluid	Phase IV

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

Drug Information available for: Hyaluronidase

U.S. FDA Resources

Further study details as provided by Baxter Healthcare Corporation:

Primary Outcome Measures:

HYLENEX-facilitated Subcutaneous (SC) Rehydration Success [ Time Frame: At emergency department discharge (mean time to discharge = 7.03 ± 7.57 hr) ] [ Designated as safety issue: No ]
Successfully rehydrated (as medically judged by treating physician) without rescue therapy (ie, without receiving fluids via an alternate route), and discharged to home
Modified HYLENEX-facilitated Subcutaneous (SC) Rehydration Success [ Time Frame: At emergency department discharge (mean time to discharge = 7.03 ± 7.57 hr) ] [ Designated as safety issue: No ]
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

Secondary Outcome Measures:

Number of Attempts Needed to Successfully Place Subcutaneous (SC) Catheter [ Time Frame: At end of placement of SC catheter ] [ Designated as safety issue: No ]
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) ] [ Designated as safety issue: No ]
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.

Enrollment:	52
Study Start Date:	August 2007
Study Completion Date:	June 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: HYLENEX recombinant

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.

Eligibility

Ages Eligible for Study:	2 Months to 10 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00477152

Sponsors and Collaborators

Baxter Healthcare Corporation

Halozyme Therapeutics

PPD

Investigators

Study Director:

George E Harb, MD

Baxter Healthcare Corporation

More Information

Publications:

Allen CH, Etzwiler LS, Miller MK, Maher G, Mace S, Hostetler MA, Smith SR, Reinhardt N, Hahn B, Harb G; INcreased Flow Utilizing Subcutaneously-Enabled Pediatric Rehydration Study Collaborative Research Group. Recombinant human hyaluronidase-enabled subcutaneous pediatric rehydration. Pediatrics. 2009 Nov;124(5):e858-67. Epub 2009 Oct 5.

Gorelick MH, Shaw KN, Murphy KO. Validity and reliability of clinical signs in the diagnosis of dehydration in children. Pediatrics. 1997 May;99(5):E6.

Responsible Party:	Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:	NCT00477152 History of Changes
Other Study ID Numbers:	1838-003
Study First Received:	May 18, 2007
Results First Received:	September 12, 2011
Last Updated:	November 22, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Baxter Healthcare Corporation:

dehydration
fluid therapy
pediatrics
emergency medicine
hyaluronoglucosaminidase
hyaluronidase

hypodermoclysis
clysis
subcutaneous hydration
subcutaneous rehydration
hyaluronan
rHuPH20

Additional relevant MeSH terms:

Dehydration
Water-Electrolyte Imbalance
Metabolic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on February 12, 2012