Subcutaneous Rehydration Compared to Intravenous Rehydration
PEDs-II
Subcutaneous Rehydration With Hylenex Compared to Intravenous Rehydration in Infants and Young Children With Mild to Moderate Dehydration
1 other identifier
interventional
148
1 country
25
Brief Summary
Randomized (1:1 ratio) study of subcutaneous (SC) versus intravenous (IV) fluid rehydration in mildly to moderately dehydrated pediatric patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Oct 2008
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 15, 2008
CompletedFirst Posted
Study publicly available on registry
October 16, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedResults Posted
Study results publicly available
November 7, 2018
CompletedNovember 7, 2018
October 1, 2018
1.1 years
October 15, 2008
September 5, 2018
October 10, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Mean Total Volume of Fluid Administered at a Single Infusion Site, From the Start to the Cessation of Fluid Administration, for All Randomized Participants
It was anticipated that most participants in this study would be hydrated through only one infusion site. For participants who received fluid at more than one administration site, a single infusion site was defined as the anatomical site at which the majority of the total infusion volume was infused. The term "anatomical site" was designated as: 1) the back; 2) left thigh; 3) right thigh; 4) abdomen; or 5) chest.
During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)
Mean Total Volume of Fluid Administered at a Single Infusion Site, From the Start to the Cessation of Fluid Administration, for Non-rescued Participants
It was anticipated that most participants in this study would be hydrated through only one infusion site. For participants who received fluid at more than one administration site, a single infusion site was defined as the anatomical site at which the majority of the total infusion volume was infused. The term "anatomical site" was designated as: 1) the back; 2) left thigh; 3) right thigh; 4) abdomen; or 5) chest. Participants randomized to receive intravenous isotonic fluid were permitted to receive subcutaneous fluid administration by hylenex-facilitated infusion as rescue.
During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)
Mean Total Volume of Fluid Administered at a Single Infusion Site, From the Start to the Cessation of Fluid Administration, for All Rescued Participants
It was anticipated that most participants in this study would be hydrated through only one infusion site. For participants who received fluid at more than one administration site, a single infusion site was defined as the anatomical site at which the majority of the total infusion volume was infused. The term "anatomical site" was designated as: 1) the back; 2) left thigh; 3) right thigh; 4) abdomen; or 5) chest. Participants randomized to receive intravenous isotonic fluid were permitted to receive subcutaneous fluid administration by hylenex-facilitated infusion as rescue.
During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)
Secondary Outcomes (37)
Mean Total Volume of Fluid Administered at All Infusion Sites, From the Start to the Cessation of Fluid Administration, for All Randomized Participants
During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)
Mean Total Volume of Fluid Administered at All Infusion Sites, From the Start to the Cessation of Fluid Administration, for All Randomized Participants Achieving > 200 mL
During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)
Mean Total Volume of Fluid Administered at All Infusion Sites, From the Start to the Cessation of Fluid Administration, for Non-rescued Participants Achieving > 200 mL
During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)
Mean Total Volume of Fluid Administered at All Infusion Sites, From the Start to the Cessation of Fluid Administration, for All Rescued Participants Achieving > 200 mL
During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)
Mean Flow Rate, Delivered Per Unit Time, for All Randomized Participants
During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)
- +32 more secondary outcomes
Study Arms (2)
Subcutaneous
ACTIVE COMPARATORIsotonic fluid rehydration by SC administration with hylenex (150 Units in 1 mL)
Intravenous
ACTIVE COMPARATORIsotonic fluid rehydration by IV
Interventions
Eligibility Criteria
You may qualify if:
- Children of either gender from one month to ≤10 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.
You may not qualify if:
- 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 milliequivalents per liter \[mEq/L\]) 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Halozyme Therapeuticslead
- Baxter Healthcare Corporationcollaborator
Study Sites (25)
Connecticut Children's Medical Center
Hartford, Connecticut, 06106, United States
Arnold Palmer Hospital for Children
Orlando, Florida, 32806, United States
Tampa General Hospital Children's Medical Center
Tampa, Florida, 33606, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322, United States
Children's Healthcare of Atlanta - Scottish Rite
Atlanta, Georgia, 30342, United States
North Georgia Clinical Research
Dalton, Georgia, 30721, United States
Children's Memorial Hospital
Chicago, Illinois, 60614, United States
Memorial Hospital
South Bend, Indiana, 46601, United States
University of Louisville
Louisville, Kentucky, 40202, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121, United States
William Beaumont Hospital
Troy, Michigan, 48085, United States
The Children's Mercy Hospital & Clinics
Kansas City, Missouri, 64108, United States
UMDNJ/Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08903, United States
St. Joseph's Children's Hospital
Paterson, New Jersey, 07503, United States
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, 87131, United States
New York Methodist Hospital
Brooklyn, New York, 11215, United States
Staten Island University Hospital Emergency Department
Staten Island, New York, 10305, United States
Children's Hospital at Montefiore
The Bronx, New York, 10956, United States
Rainbow Children's and Babies Hospital
Cleveland, Ohio, 44106, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
Dell Children's Medical Center
Austin, Texas, 78723, United States
Children's Medical Center Dallas
Dallas, Texas, 75235, United States
Cook Children's Medical Center
Fort Worth, Texas, 76104, United States
Texas Children's Hospital
Houston, Texas, 77030, United States
Related Publications (1)
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.
PMID: 23062548DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dimitrios Chondros, M.D., Chief Medical Officer
- Organization
- Halozyme Therapeutics
Study Officials
- PRINCIPAL INVESTIGATOR
Coburn H Allen, MD
Baylor College of Medicine
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 15, 2008
First Posted
October 16, 2008
Study Start
October 1, 2008
Primary Completion
November 1, 2009
Study Completion
December 1, 2009
Last Updated
November 7, 2018
Results First Posted
November 7, 2018
Record last verified: 2018-10