Clinical trial NCT00773175: Subcutaneous Rehydration Compared to Intravenous Rehydration
Official title: Subcutaneous Rehydration With Hylenex Compared to Intravenous Rehydration in Infants and Young Children With Mild to Moderate Dehydration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dehydration
Keywords: pediatric
hylenex
subcutaneous infusion
hyaluronidase
rHuPH20
recombinant human hyaluronidase
Lead sponsor: Halozyme Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: Baxter Healthcare Corporation
First posted: 2008-10-16
Enrollment: 148
Sex: ALL
Minimum age (years): 30
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 criteria: Inclusion Criteria:

* 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.

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 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.

Primary outcomes:
measure: Mean Total Volume of Fluid Administered at a Single Infusion Site, From the Start to the Cessation of Fluid Administration, for All Randomized Participants
timeFrame: During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)
measure: Mean Total Volume of Fluid Administered at a Single Infusion Site, From the Start to the Cessation of Fluid Administration, for Non-rescued Participants
timeFrame: During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)
measure: Mean Total Volume of Fluid Administered at a Single Infusion Site, From the Start to the Cessation of Fluid Administration, for All Rescued Participants
timeFrame: During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)
Secondary outcomes:
measure: Mean Total Volume of Fluid Administered at All Infusion Sites, From the Start to the Cessation of Fluid Administration, for All Randomized Participants
timeFrame: During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)
measure: 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
timeFrame: During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)
measure: 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
timeFrame: During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)
measure: 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
timeFrame: During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)
measure: Mean Flow Rate, Delivered Per Unit Time, for All Randomized Participants
timeFrame: During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)
measure: Mean Flow Rate, Delivered Per Unit Time, for All Non-rescued Participants
timeFrame: During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)
measure: Mean Flow Rate, Delivered Per Unit Time, for All Rescued Participants
timeFrame: During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)
measure: Mean Flow Rate, Delivered by Volume Per Unit Body Weight Per Unit Time, for All Randomized Participants
timeFrame: During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)
measure: Mean Flow Rate, Delivered by Volume Per Unit Body Weight Per Unit Time, for All Non-rescued Participants
timeFrame: During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)
measure: Mean Flow Rate, Delivered by Volume Per Unit Body Weight Per Unit Time, for All Rescued Participants
timeFrame: During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)
measure: Number of Participants Achieving a Maximum Flow Rate of > 2 Milliliters Per Minute (mL/Min), as an Indication of Successful Hydration
timeFrame: During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)
measure: Number of Participants Administered at Least 200 Milliliter (mL) Total Volume at a Single Infusion Site, From the Start to the Cessation of Fluid Administration
timeFrame: During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)
measure: Number of Participants With the Indicated Type of Adverse Events
timeFrame: up to 7 days after hospital discharge
measure: Number of Participants With Normal Physical Examination Findings at Baseline That Shifted to Abnormal at the End of Fluid Administration
timeFrame: Baseline; after infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)
measure: Mean Change From Baseline in Heart Rate
timeFrame: Baseline; after infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)
measure: Mean Change From Baseline in Respiratory Rate
timeFrame: Baseline; after infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)
measure: Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure
timeFrame: Baseline; after infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)
measure: Mean Change From Baseline in the Face, Legs, Activity, Cry, Consolability (FLACC) Pain Scale Score
timeFrame: Before infusion (Baseline); after infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)
measure: Number of Participants With the Indicated Type of Fluid Administered
timeFrame: During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)
measure: Infusion Duration During the Initial Infusion
timeFrame: first hour of infusion
measure: Change From Baseline in Hydration Status According to the Gorelick Assessment at the End of Fluid Infusion
timeFrame: Baseline; during the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)
measure: Percent Change From Baseline in Body Weight
timeFrame: Baseline; during the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)
measure: Number of Participants With the Indicated Type of Rescue Route Therapy Administered
timeFrame: During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)
measure: Number of Participants Classified With the Indicated Healthcare Provider Responses to the Questions Comprising the Healthcare Provider Global Satisfaction Questionnaire
timeFrame: During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)
measure: Number of Participants Classified With the Indicated Healthcare Provider Responses to the Question: How Does This Therapy Compare to Your Experience With IV (for SC Group) / SC (for IV Group) Therapy?
timeFrame: During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)
measure: Number of Participants Classified With the Indicated Parent/Guardian Responses to the Questions Comprising the Parent / Guardian Global Satisfaction Questionnaire
timeFrame: During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)
measure: Number of Participants With the Indicated Number of Different Anatomical Administration Sites Needed After the Start of Fluid Administration
timeFrame: During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)
measure: Number of Participants Experiencing Reductions in Flow Rate
timeFrame: During the infusion (single bolus dose of hylenex [1 hr], followed by subcutaneous fluid for 1 hour to 72 hours)
measure: Number of Participants Who Received Needle Placement by People With the Indicated Level of Staff Training
timeFrame: average of approximately 3 minutes
measure: Number of Participants for Which the Indicated Number of Additional Personnel Was Involved in Needle Placement
timeFrame: average of approximately 3 minutes
measure: Time From the Start of Infusion to the Time of Emergency Department (ED) Discharge
timeFrame: up to approximately 26 hours
measure: Time From Randomization to the First Drop of Fluid Infusion
timeFrame: up to approximately 110 and 220 minutes for the SC and IV arms, respectively
measure: Number of Participants With the Indicated Number of Needle Stick Attempts Needed to Initiate Fluid Administration
timeFrame: average of approximately 3 minutes
measure: Number of Participants for Which the Indicated Type of Infusion Device Was Used
timeFrame: average of approximately 3 minutes
measure: Number of Participants for Which the Indicated Gauge for Infusion Device Was Used
timeFrame: average of approximately 3 minutes
measure: Number of Participants Discharged From the ED to Home or the Hospital
timeFrame: up to approximately 26 hours
measure: Number of Participants With the Indicated Reason for Rehospitalization Within 48 and 72 Hours After Discharge
timeFrame: from randomization up to approximately 98 hours
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Connecticut Children's Medical Center
state: Connecticut
city: Orlando
country: United States
facility: Arnold Palmer Hospital for Children
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital Children's Medical Center
state: Florida
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta - Scottish Rite
state: Georgia
city: Dalton
country: United States
facility: North Georgia Clinical Research
state: Georgia
city: Chicago
country: United States
facility: Children's Memorial Hospital
state: Illinois
city: South Bend
country: United States
facility: Memorial Hospital
state: Indiana
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Troy
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Kansas City
country: United States
facility: The Children's Mercy Hospital & Clinics
state: Missouri
city: New Brunswick
country: United States
facility: UMDNJ/Robert Wood Johnson Medical School
state: New Jersey
city: Paterson
country: United States
facility: St. Joseph's Children's Hospital
state: New Jersey
city: Albuquerque
country: United States
facility: University of New Mexico Health Sciences Center
state: New Mexico
city: Bronx
country: United States
facility: Children's Hospital at Montefiore
state: New York
city: Brooklyn
country: United States
facility: New York Methodist Hospital
state: New York
city: Staten Island
country: United States
facility: Staten Island University Hospital Emergency Department
state: New York
city: Cleveland
country: United States
facility: Rainbow Children's and Babies Hospital
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Austin
country: United States
facility: Dell Children's Medical Center
state: Texas
city: Dallas
country: United States
facility: Children's Medical Center Dallas
state: Texas
city: Fort Worth
country: United States
facility: Cook Children's Medical Center
state: Texas
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Coburn H Allen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.