Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Subcutaneous Rehydration Compared to Intravenous Rehydration (PEDs-II)

This study has been completed.
Baxter Healthcare Corporation
Information provided by:
Halozyme Therapeutics Identifier:
First received: October 15, 2008
Last updated: December 2, 2011
Last verified: December 2011
Randomized (1:1 ratio) study of SC versus IV fluid rehydration in mildly to moderately dehydrated pediatric patients.

Condition Intervention Phase
Drug: recombinant human hyaluronidase
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
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:

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 ]

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 ]
  • 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 ]
  • Mean maximum flow rate achieved (averaged over any 60 minute period of time). [ Time Frame: During the infusion ]
  • 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 ]
  • 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 ]

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.

Ages Eligible for Study:   up to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00773175

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: George Harb, Therapeutic Area Lead, Baxter Healthcare Corporation Identifier: NCT00773175     History of Changes
Other Study ID Numbers: HZ2-08-03
Study First Received: October 15, 2008
Last Updated: December 2, 2011

Keywords provided by Halozyme Therapeutics:
subcutaneous infusion
recombinant human hyaluronidase

Additional relevant MeSH terms:
Water-Electrolyte Imbalance
Metabolic Diseases
Pathologic Processes processed this record on April 27, 2017