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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

October 15, 2008
December 2, 2011
October 2008
November 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00773175 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Subcutaneous Rehydration Compared to Intravenous Rehydration
Subcutaneous Rehydration With Hylenex Compared to Intravenous Rehydration in Infants and Young Children With Mild to Moderate Dehydration

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

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Dehydration
Drug: recombinant human hyaluronidase
150 Units in 1 mL
Other Name: Hylenex
  • Active Comparator: Subcutaneous
    Isotonic fluid rehydration by SC administration with hylenex (150 Units in 1 mL)
    Intervention: Drug: recombinant human hyaluronidase
  • Active Comparator: Intravenous
    Isotonic fluid rehydration by IV
    Intervention: Drug: recombinant human hyaluronidase
Spandorfer PR, Mace SE, Okada PJ, Simon HK, Allen CH, Spiro DM, Friend K, Harb G, Lebel F; Increased Flow Utilizing Subcutaneously-Enabled Pediatric Rehydration II (INFUSE-Peds II) Study Group. A randomized clinical trial of recombinant human hyaluronidase-facilitated subcutaneous versus intravenous rehydration in mild to moderately dehydrated children in the emergency department. Clin Ther. 2012 Nov;34(11):2232-45. doi: 10.1016/j.clinthera.2012.09.011. Epub 2012 Oct 11.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
186
December 2009
November 2009   (final data collection date for primary outcome measure)

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.
Both
up to 3 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00773175
HZ2-08-03
No
George Harb, Therapeutic Area Lead, Baxter Healthcare Corporation
Halozyme Therapeutics
Baxter Healthcare Corporation
Principal Investigator: Coburn H Allen, MD Texas Children's Hospital
Halozyme Therapeutics
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP