Establishing intravenous (IV) access can be difficult, especially in children with dehydration, who often have small, volume‐depleted veins. Subcutaneous (SC) rehydration therapy is an alternative to IV rehydration therapy when parenteral treatment is indicated in patients with mild to moderate dehydration. A previously published clinical trial provided safety, efficacy, and tolerability data on recombinant human hyaluranidase (rHuPH20)–facilitated SC fluid administration in children. The objective of the INcreased Flow Utilizing Subcutaneously‐Enabled Pediatric Rehydration II (INFUSE‐Peds II) study is to evaluate whether rHuPH20‐facilitated SC fluid administration can be given safely and effectively in appropriate volumes, comparable to the IV route, in children with mild to moderate dehydration.
Children aged 1 month to 10 years with mild to moderate dehydration were enrolled in this ongoing, phase IV, open‐label noninferiority, company‐sponsored clinical trial. Patients were randomized to treatment groups (SC or IV). stratified based on baseline body weight and dehydration severity, Patients received 20 mL/kg isotonic fluid via the SC or IV route over 1 hour and additional fluid, up to 72 hours as needed, until clinically re‐hydrated. The primary end point was total fluid volume administered at a single infusion site; secondary end points included change from baseline in dehydration symptoms and dehydration score, ease of use outcomes, and safety evaluations, including adverse events (AEs).
Interim analysis is reported on 74 patients (37 SC, 37 IV), mean age 1.98 ± 1.56 years. Mean volume infused was 374 ± 92.1 mL SC versus 491 ± 645.3 mL IV. Mean duration of infusion at a single site was 2.8 ± 3.29 hours SC versus 6.0 ± 13.75 hours IV. Adjusted for duration of infusion, mean volume infused was 445 mL SC versus 419 mL IV. Mean improvement in dehydration score was −2.8 (−3.2, −2.4) SC and −2.4 (−3.0, −1.8) IV; mean weight change was +0.3 kg (+0.2, +0.4) in both groups. Table 1 summarizes ease‐of‐use assessments. Initial catheter placement was successful in 97% SC versus 49% IV (OR = 38.0; 4.7‐306.9) Crossover for rescue treatment occurred in 0 of 37 SC versus 8 of 37 IV patients; median catheter placement time was 0.6 minutes (0.25, 0.92 minutes) SC versus 5.0 minutes (1.0, 9.92 minutes) IV. AEs were mild to moderate in severity: pain (73% SC; 86% IV), erythema (73% SC; 6.9% IV), swelling (80% SC; 0% IV), and extravasation (0% SC; 3% IV).
Preliminary results reveal rHuPH20‐facilitated SC infusions were generally safe and well tolerated. Duration‐adjusted mean volume of fluids and resolution of dehydration were comparable for SC and IV. Catheter placement took less time and was more successful with the SC versus the IV route.
S. Mace, Baxter Healthcare Corporation, research funding; P. Spandorfer, Baxter Healthcare Corporation, research funding, speakers bureau; G. Harb, Baxter Healthcare Corporation, employee, none.
To cite this abstract:Mace S, Spandorfer P, Harb G. Rehydration Therapy in Infants and Children: Recombinant Human Hyaluronidase‐Facilitated Subcutaneous Versus Intravenous Fluid Administration. Abstract published at Hospital Medicine 2010, April 8-11, Washington, D.C. Abstract 89. Journal of Hospital Medicine. 2010; 5 (suppl 1). https://www.shmabstracts.com/abstract/rehydration-therapy-in-infants-and-children-recombinant-human-hyaluronidasefacilitated-subcutaneous-versus-intravenous-fluid-administration/. Accessed May 26, 2019.