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
  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:


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
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 ClinicalTrials.gov identifier: NCT00773175

  Hide Study Locations
Locations
United States, Connecticut
Connecticut Children's Medical Center
Hartford, Connecticut, United States, 06106
United States, Florida
Arnold Palmer Hospital for Children
Orlando, Florida, United States, 32806
Tampa General Hospital Children's Medical Center
Tampa, Florida, United States, 33606
United States, Georgia
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
Children's Healthcare of Atlanta - Scottish Rite
Atlanta, Georgia, United States, 30342
North Georgia Clinical Research
Dalton, Georgia, United States, 30721
United States, Illinois
Children's Memorial Hospital
Chicago, Illinois, United States, 60614
United States, Indiana
Memorial Hospital
South Bend, Indiana, United States, 46601
United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40202
United States, Louisiana
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
United States, Michigan
William Beaumont Hospital
Troy, Michigan, United States, 48085
United States, Missouri
The Children's Mercy Hospital & Clinics
Kansas City, Missouri, United States, 64108
United States, New Jersey
UMDNJ/Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903
St. Joseph's Children's Hospital
Paterson, New Jersey, United States, 07503
United States, New Mexico
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, United States, 87131
United States, New York
Children's Hospital at Montefiore
Bronx, New York, United States, 10956
New York Methodist Hospital
Brooklyn, New York, United States, 11215
Staten Island University Hospital Emergency Department
Staten Island, New York, United States, 10305
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Rainbow Children's and Babies Hospital
Cleveland, Ohio, United States, 44106
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
United States, Texas
Dell Children's Medical Center
Austin, Texas, United States, 78723
Children's Medical Center Dallas
Dallas, Texas, United States, 75235
Cook Children's Medical Center
Fort Worth, Texas, United States, 76104
Texas Children's Hospital
Houston, Texas, United States, 77030
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
Metabolic Diseases
Pathologic Processes
Water-Electrolyte Imbalance

ClinicalTrials.gov processed this record on October 23, 2014