Treatment of dehydration in the Emergency Department (ED) presents special challenges in infants and children. Their veins can be too small or fragile to allow easy intravenous (IV) access, especially if the vessels are collapsed. In patients who need parenteral fluid therapy, subcutaneous (SC) hydration has been a safe and effective option. Hyaluronidase is an enzyme that depolymerizes hyaluronan, the major SC barrier to diffusion. Recombinant human hyaluronidase (rHuPH20) is now approved as an adjuvant to increase the dispersion and absorption of other injected drugs and SC fluids. Several clinical studies attest to its effectiveness, safety, and tolerability in adults. The objective of the Increased Flow Utilizing Subcutaneously Enabled (INFUSE) Pediatric Rehydration Study is to assess the clinical utility of adjunctive rHuPH20 in infants and children 2 months to 10 years old needing parenteral fluids and electrolytes.
In this ongoing phase IV, open‐label, multicenter study, hydration status is assessed using the 10‐item Gorelick scale. Eligible patients present to the ED with 1‐5 signs of dehydration (mild to moderate) and are either not candidates for oral replacement therapy (ORT) or have failed ORT. They are given 1 mL (150 U) SC rHuPH20 through a 24‐gauge angiocatheter placed in the anterior thigh or other suitable region, followed by a 20 mL/kg SC isotonic fluid bolus delivered over the first hour. Additional SC hydration may be continued as needed. Successful rehydration is defined as the point at which the patient can be discharged from the ED to home without the need for rescue therapy. Ease of SC catheter insertion, number of SC needle stick attempts, and time to start infusion are recorded. Total volume infused, infusion site reactions, adverse events, vital signs, temperature, and body weight are monitored throughout the study and 7‐day follow‐up. Parents' satisfaction with the procedure is recorded.
Early results in patients under 3 years receiving lactated Ringer's solution indicate that clinically indicated fluid volumes can be given with good tolerability. In most cases, this consists of a 20 mL/kg bolus in the first hour of treatment followed by maintenance fluids, for a total of approximately 200‐400 mL within the first 3 hours.
In young children with mild to moderate dehydration, SC fluid administration with adjunctive rHuPH20 may be an effective, well‐tolerated, and convenient approach to treatment.
C. Allen, Baxter Healthcare Corporation, research Funding; A. Cruz, Baxter Healthcare Corporation, research funding; B. Patel, Baxter Healthcare Corporation, research funding; E. Endom, Baxter Healthcare Corporation, research funding.
To cite this abstract:Allen C, Cruz A, Patel B, Endom E. Recombinant Human Hyaluronidase Enabled Hydration Therapy in Infants and Children. Abstract published at Hospital Medicine 2008, April 3-5, San Diego, Calif. Abstract 3. Journal of Hospital Medicine. 2008; 3 (suppl 1). https://www.shmabstracts.com/abstract/recombinant-human-hyaluronidase-enabled-hydration-therapy-in-infants-and-children/. Accessed September 17, 2019.