Subcutaneous Rehydration Compared to Intravenous Rehydration (PEDs-II)
This study has been completed.
Sponsor:
Halozyme Therapeutics
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
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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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00773175
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Hide Study LocationsLocations
| 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 | |
| Rainbow Children's and Babies Hospital | |
| Cleveland, Ohio, United States, 44106 | |
| Cleveland Clinic Foundation | |
| Cleveland, Ohio, United States, 44195 | |
| 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 Water-Electrolyte Imbalance Metabolic Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on June 13, 2013