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Subcutaneous Rehydration Compared to Intravenous Rehydration (PEDs-II)

This study has been completed.
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by:
Halozyme Therapeutics
ClinicalTrials.gov Identifier:
NCT00773175
First received: October 15, 2008
Last updated: December 2, 2011
Last verified: December 2011
History of Changes
  Purpose

Randomized (1:1 ratio) study of SC versus IV fluid rehydration in mildly to moderately dehydrated pediatric patients.


Condition Intervention Phase
Dehydration
 Drug: recombinant human hyaluronidase
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Subcutaneous Rehydration With Hylenex Compared to Intravenous Rehydration in Infants and Young Children With Mild to Moderate Dehydration

Resource links provided by NLM:

MedlinePlus related topics: Dehydration
U.S. FDA Resources

Further study details as provided by Halozyme Therapeutics:

Primary Outcome Measures:
  • Mean total volume of fluid administered at a single infusion site, from the start to the cessation of fluid administration. [ Time Frame: During the infusion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion (%) of patients administered at least 200 mL total volume at a single infusion site, from the start to the cessation of fluid administration. [ Time Frame: During the infusion ] [ Designated as safety issue: No ]
  • Total volume administered at all infusion sites, from start to cessation of fluid administration for (1) the mean volume and (2) the proportion achieving > 200 mL. [ Time Frame: During the infusion ] [ Designated as safety issue: No ]
  • Mean maximum flow rate achieved (averaged over any 60 minute period of time). [ Time Frame: During the infusion ] [ Designated as safety issue: No ]
  • Proportion (%) of patients achieving a maximum flow rate (averaged over any 60 minute period of time) of > 2 mL/min. [ Time Frame: During the infusion ] [ Designated as safety issue: No ]
  • Safety and tolerability of infusion based on AEs, physical examinations including assessment of infusion sites, vital signs, and pain assessments (FLACC scoring). [ Time Frame: During the infusion ] [ Designated as safety issue: No ]

Estimated Enrollment: 186
Study Start Date: October 2008
Study Completion Date: December 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Subcutaneous
Isotonic fluid rehydration by SC administration with hylenex (150 Units in 1 mL)
 Drug: recombinant human hyaluronidase
150 Units in 1 mL
Other Name: Hylenex
Active Comparator: Intravenous
Isotonic fluid rehydration by IV
 Drug: recombinant human hyaluronidase
150 Units in 1 mL
Other Name: Hylenex

Detailed Description:

This is a prospective, randomized (1:1 ratio), open-label, parallel group, multicenter, multi-national, study of SC versus IV fluid rehydration in mildly to moderately dehydrated pediatric patients treated in the Emergency Department (ED), inpatient pediatric unit, and/or outpatient urgent care facility. It is expected that up to 186 patients, in order to achieve 148 evaluable patients, will be randomized in a 1:1 ratio to receive isotonic fluid rehydration by either SC administration with hylenex (150 Units) or IV without hylenex.

  Eligibility

Ages Eligible for Study:   up to 3 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children of either gender from one month to <3 years of age.
  • Patients with mild or moderate dehydration
  • Healthy child except for the underlying etiology for dehydration
  • Pre-dehydration body weight ≥ 5th percentile for age
  • Parents or legal guardian(s) available to provide informed consent.

Exclusion Criteria:

  • Severe dehydration
  • Shock or life-threatening situation (life expectancy < 10 days).
  • Requirement for IV access for any indication other than for treatment of dehydration.
  • Indwelling IV catheter, except for one intended only for collection of clinical laboratory specimens.
  • Any condition precluding SC infusion or infusion site evaluation
  • Any reason (prior to study enrollment) for a hospital admission or an extended stay in the ED for other than dehydration.
  • Known hypersensitivity to hyaluronidase or hylenex.
  • Known hyponatremia (< 130 mEg/L) or hypernatremia (> 155 mEq/L).
  • Known hypokalemia (< 3.0 mEq/L).
  • Any medical condition likely to interfere with the patient's ability to fully complete all protocol-specified interventions, the ability to undergo all protocol-specified assessments, or likely to prolong the patient's need for medical attention beyond that required for treatment of dehydration.
  • Participation in an investigational drug or device study within 30 days prior to enrollment in this study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00773175

  Show 25 Study Locations
Sponsors and Collaborators
Halozyme Therapeutics
Baxter Healthcare Corporation
Investigators
Principal Investigator: Coburn H Allen, MD Texas Children's Hospital
  More Information

No publications provided by Halozyme Therapeutics

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: George Harb, Therapeutic Area Lead, Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT00773175     History of Changes
Other Study ID Numbers: HZ2-08-03
Study First Received: October 15, 2008
Last Updated: December 2, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Halozyme Therapeutics:
pediatric
hylenex
subcutaneous infusion
 hyaluronidase
rHuPH20
recombinant human hyaluronidase

Additional relevant MeSH terms:
Dehydration
Water-Electrolyte Imbalance
Metabolic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013