The aim of the study is to evaluate the safety, effectiveness and ease of use of subcutaneous (SC) rehydration using HYLENEX-augmented SC infusion of fluids and electrolytes for the rehydration of pediatric patients with mild to moderate dehydration.
Pediatric patients (2 months to 10 years of age), presenting to the emergency department (ED) with mild to moderate dehydration and requiring parenteral rehydration, were treated with HYLENEX-augmented subcutaneous (SC) rehydration. An initial volume of 20 mL/kg of isotonic fluid was to be administered by continuous SC infusion over the first hour, and additional SC rehydration could be continued as clinically indicated. The preferred anatomic site for the SC infusion was the anterior thigh, unless there was an overriding preference for an alternate site. The duration of HYLENEX-augmented SC rehydration was to be a minimum of 1 hour and a maximum of 72 hours. The investigator or designee performed a clinical assessment of the subject's hydration status at baseline and at the end of SC infusion or at discharge from the ED. Other assessments of effectiveness and safety were made directly during the rehydration period and ED stay, and by telephone on Days 3 and 7 after discharge from the ED.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
52
Single 150 U subcutaneous (SC) HYLENEX dose administered immediately prior to start of SC infusion of rehydration fluid. Additional 150 U HYLENEX dose to be administered prior to any additional fluid infusion beyond 24 hours.
HYLENEX-facilitated Subcutaneous (SC) Rehydration Success
Successfully rehydrated (as medically judged by treating physician) without rescue therapy (ie, without receiving fluids via an alternate route), and discharged to home
Time frame: At emergency department discharge (mean time to discharge = 7.03 ± 7.57 hr)
Modified HYLENEX-facilitated Subcutaneous (SC) Rehydration Success
Successfully rehydrated (as medically judged by treating physician) without rescue therapy (ie, without receiving fluids via an alternate route), regardless of emergency department discharge destination
Time frame: At emergency department discharge (mean time to discharge = 7.03 ± 7.57 hr)
Number of Attempts Needed to Successfully Place Subcutaneous (SC) Catheter
Time frame: At end of placement of SC catheter
Post-treatment Gorelick Dehydration Score
Score indicates the number of moderate-to-severe signs/symptoms of dehydration, based on assessment of each of the following 10 patient parameters: general condition, quality of radial pulse, quality of respiration, skin elasticity, eyes, tears, mucous membranes, urine output, heart rate and fingertip capillary refill time. Minimum score = 0; maximum score = 10.
Time frame: At baseline and at either the end of subcutaneous infusion (mean duration = 5.73 ± 9.15 hr) or emergency department discharge (mean time to discharge = 7.03 ± 7.57 hr)
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