Recombinant Human Hyaluronidase-Facilitated Subcutaneous vs Intravenous Fluid Administration in Children

2.50
Hdl Handle:
http://hdl.handle.net/10755/162359
Type:
Presentation
Title:
Recombinant Human Hyaluronidase-Facilitated Subcutaneous vs Intravenous Fluid Administration in Children
Abstract:
Recombinant Human Hyaluronidase-Facilitated Subcutaneous vs
Intravenous Fluid Administration in Children
Conference Sponsor:Emergency Nurses Association
Conference Year:2010
Author:Allen, Coburn H., MD
P.I. Institution Name:Texas Children's Hospital
Title:Assistant Professor
Contact Address:6621 Fannin, Houston, TX, 77030, USA
Contact Telephone:832-824-5436
Co-Authors:Sharon E. Mace, MD, FACEP, FAAP; David Henderson, RN; George Harb, MD, MPH; Keith Friend, MD
[ENA Annual Conference - Research Presentation]
Purpose: Establishing intravenous (IV) access can be difficult in children, who often have small 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 hyaluronidase (rHuPH20)-facilitated SC fluid administration in children. The purpose of the INcreased Flow Utilizing Subcutaneously-Enabled Pediatric Rehydration II (INFUSE-Peds II) study was to demonstrate that in a pediatric population with mild to moderate dehydration, rHuPH20-facilitated SC fluid administration can be given safely and effectively in clinically-appropriate volumes, no less than that delivered IV.

Design: A Phase IV, randomized, open-label, non-inferiority, clinical trial.

Setting: This multicenter trial was conducted in patients presenting to emergency departments.

Participants/Subjects: Subjects were otherwise healthy children aged 1 month to 10 years with mild to moderate dehydration (Gorelick scores of 1 to 6).

Methods: 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 over 1 hr and additional fluid, as needed, until clinically rehydrated up to 72 hrs, via SC or IV administration. The primary end point was total fluid volume administered at a single infusion site. Secondary end points included dehydration symptoms, dehydration score, ease of use outcomes, and safety evaluations, including adverse events (AEs).

Results/Outcomes: Enrollment (N=148) was complete in December, 2009. Interim analysis is reported here on 74 patients (37 SC, 37 IV), mean age 1.98 years (+/- 1.56). Mean volume infused was 374 mL ( +/- 292.1) SC vs 491 mL (+/- 645.3) IV. Mean duration of infusion at a single site was 2.8 hours (+/- 3.29) SC vs 6.0 hours (+/- 13.75) IV. Adjusted for duration of infusion, mean volume infused was 445 mL SC vs 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. Initial catheter placement was successful in 97% SC vs 49% IV (OR=38.0; 4.7-306.9). Crossover for rescue treatment occurred in 0/37 SC vs 8/37 IV patients; median catheter placement time was 0.6 min (0.25, 0.92) SC vs 5.0 min (1.0, 9.92) 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). Final analysis of data from the total study population will be completed and presented at the Emergency Nurses Association (ENA) Annual Conference in September 2010.

Implications: Preliminary results revealed rHuPH20-facilitated SC infusions were generally safe and well tolerated, duration-adjusted mean volume of fluids and resolution of dehydration signs and symptoms were comparable for both routes of administration, while catheter placement was quicker and more often successful with SC than IV, suggesting the SC route represents a useful alternative to IV for isotonic fluid administration in this patient population. Final conclusions based on analysis of the full data set will be presented at the ENA conference.
Repository Posting Date:
27-Oct-2011
Date of Publication:
17-Oct-2011
Sponsors:
Emergency Nurses Association

Full metadata record

DC FieldValue Language
dc.typePresentationen_GB
dc.titleRecombinant Human Hyaluronidase-Facilitated Subcutaneous vs Intravenous Fluid Administration in Childrenen_GB
dc.identifier.urihttp://hdl.handle.net/10755/162359-
dc.description.abstract<table><tr><td colspan="2" class="item-title">Recombinant Human Hyaluronidase-Facilitated Subcutaneous vs <br/>Intravenous Fluid Administration in Children<br/></td></tr><tr class="item-sponsor"><td class="label">Conference Sponsor:</td><td class="value">Emergency Nurses Association</td></tr><tr class="item-year"><td class="label">Conference Year:</td><td class="value">2010</td></tr><tr class="item-author"><td class="label">Author:</td><td class="value">Allen, Coburn H., MD</td></tr><tr class="item-institute"><td class="label">P.I. Institution Name:</td><td class="value">Texas Children's Hospital</td></tr><tr class="item-author-title"><td class="label">Title:</td><td class="value">Assistant Professor</td></tr><tr class="item-address"><td class="label">Contact Address:</td><td class="value">6621 Fannin, Houston, TX, 77030, USA</td></tr><tr class="item-phone"><td class="label">Contact Telephone:</td><td class="value">832-824-5436</td></tr><tr class="item-email"><td class="label">Email:</td><td class="value">challen@bcm.edu</td></tr><tr class="item-co-authors"><td class="label">Co-Authors:</td><td class="value">Sharon E. Mace, MD, FACEP, FAAP; David Henderson, RN; George Harb, MD, MPH; Keith Friend, MD</td></tr><tr><td colspan="2" class="item-abstract">[ENA Annual Conference - Research Presentation] <br/>Purpose: Establishing intravenous (IV) access can be difficult in children, who often have small 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 hyaluronidase (rHuPH20)-facilitated SC fluid administration in children. The purpose of the INcreased Flow Utilizing Subcutaneously-Enabled Pediatric Rehydration II (INFUSE-Peds II) study was to demonstrate that in a pediatric population with mild to moderate dehydration, rHuPH20-facilitated SC fluid administration can be given safely and effectively in clinically-appropriate volumes, no less than that delivered IV.<br/><br/>Design: A Phase IV, randomized, open-label, non-inferiority, clinical trial. <br/><br/>Setting: This multicenter trial was conducted in patients presenting to emergency departments.<br/><br/>Participants/Subjects: Subjects were otherwise healthy children aged 1 month to 10 years with mild to moderate dehydration (Gorelick scores of 1 to 6).<br/><br/>Methods: 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 over 1 hr and additional fluid, as needed, until clinically rehydrated up to 72 hrs, via SC or IV administration. The primary end point was total fluid volume administered at a single infusion site. Secondary end points included dehydration symptoms, dehydration score, ease of use outcomes, and safety evaluations, including adverse events (AEs).<br/><br/>Results/Outcomes: Enrollment (N=148) was complete in December, 2009. Interim analysis is reported here on 74 patients (37 SC, 37 IV), mean age 1.98 years (+/- 1.56). Mean volume infused was 374 mL ( +/- 292.1) SC vs 491 mL (+/- 645.3) IV. Mean duration of infusion at a single site was 2.8 hours (+/- 3.29) SC vs 6.0 hours (+/- 13.75) IV. Adjusted for duration of infusion, mean volume infused was 445 mL SC vs 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. Initial catheter placement was successful in 97% SC vs 49% IV (OR=38.0; 4.7-306.9). Crossover for rescue treatment occurred in 0/37 SC vs 8/37 IV patients; median catheter placement time was 0.6 min (0.25, 0.92) SC vs 5.0 min (1.0, 9.92) 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). Final analysis of data from the total study population will be completed and presented at the Emergency Nurses Association (ENA) Annual Conference in September 2010. <br/><br/>Implications: Preliminary results revealed rHuPH20-facilitated SC infusions were generally safe and well tolerated, duration-adjusted mean volume of fluids and resolution of dehydration signs and symptoms were comparable for both routes of administration, while catheter placement was quicker and more often successful with SC than IV, suggesting the SC route represents a useful alternative to IV for isotonic fluid administration in this patient population. Final conclusions based on analysis of the full data set will be presented at the ENA conference.<br/></td></tr></table>en_GB
dc.date.available2011-10-27T10:26:48Z-
dc.date.issued2011-10-17en_GB
dc.date.accessioned2011-10-27T10:26:48Z-
dc.description.sponsorshipEmergency Nurses Associationen_GB
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