Recombinant Human Hyaluronidase-Facilitated Subcutaneous Versus Intravenous Rehydration Therapy In Infants And Children

2.50
Hdl Handle:
http://hdl.handle.net/10755/157053
Category:
Abstract
Type:
Presentation
Title:
Recombinant Human Hyaluronidase-Facilitated Subcutaneous Versus Intravenous Rehydration Therapy In Infants And Children
Author(s):
Spandorfer, Philip; Simon, Harold
Author Details:
Dr. Philip Spandorfer, Children's Healthcare of Atlanta, Atlanta, Georgia, USA, email: pip.spandorfer@yahoo.com; Harold Simon
Abstract:
POSTER PURPOSE: The objective of the INcreased Flow Utilizing Subcutaneously-Enabled Pediatric Rehydration II (INFUSE-Peds II) study is to evaluate whether recombinant human hyaluronidase (rHuPH20)-facilitated subcutaneous fluid administration can be done safely and effectively in appropriate volumes, compared with the intravenous route, in children with mild to moderate dehydration. BACKGROUND/SIGNIFICANCE: Establishing intravenous access can be difficult, especially in children with dehydration, who often have small, volume-depleted veins. Subcutaneous rehydration therapy is an alternative to intravenous rehydration therapy when parenteral treatment is indicated in patients with mild to moderate dehydration. A previously published clinical trial demonstrated the safety, efficacy, and tolerability of rHuPH20-facilitated subcutaneous fluid administration in children. METHOD: Children aged 1 month to 10 years with mild to moderate dehydration were enrolled in an ongoing, phase IV, open-label, noninferiority, company-sponsored clinical trial. Patients were randomized to treatment groups (subcutaneous or intravenous), stratified on the basis of baseline body weight and severity of dehydration. Patients received 20 mL/kg isotonic fluid over 1 hour and additional fluid, as needed, until clinically rehydrated after up to 72 hours, via subcutaneous or intravenous administration of fluids. 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. RESULTS: Interim analysis is reported on 74 patients (37 subcutaneous, 37 intravenous), with a mean age of 1.98 (SD, 1.56) years. Mean volume infused was 374 (SD, 292.1) mL subcutaneously vs 491 (SD, 645.3) mL intravenously, and 445 mL subcutaneously vs 419 mL intravenously when adjusted for duration. Mean improvement in dehydration score was -2.8 (-3.2, -2.4) subcutaneously and -2.4 (-3.0, -1.8) intravenously; mean weight change was +0.3 kg (+0.2, +0.4) in both groups. Initial catheter placement was successful in 97% of the subcutaneous group vs 49% of the intravenous group (odds ratio, 38.0; range, 4.7 -306.9). Catheter placement failed in 0 of 37 patients in the subcutaneous group vs 8/37 patients in the intravenous group; median placement time, 0.6 min (0.25, 0.92) in the subcutaneous group vs 5.0 min (1.0, 9.92) in the intravenous group. Adverse events (subcutaneous, intravenous) were mild to moderate: pain (73%, 86%), erythema (73%, 6.9%), swelling (80%, 0%), extravasation (0%, 3%). CONCLUSIONS: Preliminary results reveal that rHuPH20-facilitated subcutaneous infusions were generally safe and well tolerated. Duration-adjusted mean volume of fluids and resolution of dehydration were comparable for both routes of administration. Catheter placement was quicker and more often successful with subcutaneous than intravenous administration.
Repository Posting Date:
26-Oct-2011
Date of Publication:
26-Oct-2011
Citation:
2010 National Teaching Institute Research Abstracts. American Journal of Critical Care, 19(3), e15-e28. doi:10.4037/ajcc2010866
Conference Date:
2010
Conference Name:
National Teaching Institute and Critical Care Exposition
Conference Host:
American Association of Critical-Care Nurses
Conference Location:
Washington, D.C., USA
Note:
This is an abstract-only submission. If the author has submitted a full-text item based on this abstract, you may find it by browsing the Virginia Henderson Global Nursing e-Repository by author. If author contact information is available in this abstract, please feel free to contact him or her with your queries regarding this submission. Alternatively, please contact the conference host, journal, or publisher (according to the circumstance) for further details regarding this item. If a citation is listed in this record, the item has been published and is available via open-access avenues or a journal/database subscription. Contact your library for assistance in obtaining the as-published article.

Full metadata record

DC FieldValue Language
dc.type.categoryAbstracten_GB
dc.typePresentationen_GB
dc.titleRecombinant Human Hyaluronidase-Facilitated Subcutaneous Versus Intravenous Rehydration Therapy In Infants And Childrenen_GB
dc.contributor.authorSpandorfer, Philipen_GB
dc.contributor.authorSimon, Harolden_GB
dc.author.detailsDr. Philip Spandorfer, Children's Healthcare of Atlanta, Atlanta, Georgia, USA, email: pip.spandorfer@yahoo.com; Harold Simonen_GB
dc.identifier.urihttp://hdl.handle.net/10755/157053-
dc.description.abstractPOSTER PURPOSE: The objective of the INcreased Flow Utilizing Subcutaneously-Enabled Pediatric Rehydration II (INFUSE-Peds II) study is to evaluate whether recombinant human hyaluronidase (rHuPH20)-facilitated subcutaneous fluid administration can be done safely and effectively in appropriate volumes, compared with the intravenous route, in children with mild to moderate dehydration. BACKGROUND/SIGNIFICANCE: Establishing intravenous access can be difficult, especially in children with dehydration, who often have small, volume-depleted veins. Subcutaneous rehydration therapy is an alternative to intravenous rehydration therapy when parenteral treatment is indicated in patients with mild to moderate dehydration. A previously published clinical trial demonstrated the safety, efficacy, and tolerability of rHuPH20-facilitated subcutaneous fluid administration in children. METHOD: Children aged 1 month to 10 years with mild to moderate dehydration were enrolled in an ongoing, phase IV, open-label, noninferiority, company-sponsored clinical trial. Patients were randomized to treatment groups (subcutaneous or intravenous), stratified on the basis of baseline body weight and severity of dehydration. Patients received 20 mL/kg isotonic fluid over 1 hour and additional fluid, as needed, until clinically rehydrated after up to 72 hours, via subcutaneous or intravenous administration of fluids. 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. RESULTS: Interim analysis is reported on 74 patients (37 subcutaneous, 37 intravenous), with a mean age of 1.98 (SD, 1.56) years. Mean volume infused was 374 (SD, 292.1) mL subcutaneously vs 491 (SD, 645.3) mL intravenously, and 445 mL subcutaneously vs 419 mL intravenously when adjusted for duration. Mean improvement in dehydration score was -2.8 (-3.2, -2.4) subcutaneously and -2.4 (-3.0, -1.8) intravenously; mean weight change was +0.3 kg (+0.2, +0.4) in both groups. Initial catheter placement was successful in 97% of the subcutaneous group vs 49% of the intravenous group (odds ratio, 38.0; range, 4.7 -306.9). Catheter placement failed in 0 of 37 patients in the subcutaneous group vs 8/37 patients in the intravenous group; median placement time, 0.6 min (0.25, 0.92) in the subcutaneous group vs 5.0 min (1.0, 9.92) in the intravenous group. Adverse events (subcutaneous, intravenous) were mild to moderate: pain (73%, 86%), erythema (73%, 6.9%), swelling (80%, 0%), extravasation (0%, 3%). CONCLUSIONS: Preliminary results reveal that rHuPH20-facilitated subcutaneous infusions were generally safe and well tolerated. Duration-adjusted mean volume of fluids and resolution of dehydration were comparable for both routes of administration. Catheter placement was quicker and more often successful with subcutaneous than intravenous administration.en_GB
dc.date.available2011-10-26T19:22:47Z-
dc.date.issued2011-10-26en_GB
dc.date.accessioned2011-10-26T19:22:47Z-
dc.identifier.citation2010 National Teaching Institute Research Abstracts. American Journal of Critical Care, 19(3), e15-e28. doi:10.4037/ajcc2010866en_GB
dc.conference.date2010en_GB
dc.conference.nameNational Teaching Institute and Critical Care Expositionen_GB
dc.conference.hostAmerican Association of Critical-Care Nursesen_GB
dc.conference.locationWashington, D.C., USAen_GB
dc.identifier.citation2010 National Teaching Institute Research Abstracts. American Journal of Critical Care, 19(3), e15-e28. doi:10.4037/ajcc2010866en_GB
dc.description.noteThis is an abstract-only submission. If the author has submitted a full-text item based on this abstract, you may find it by browsing the Virginia Henderson Global Nursing e-Repository by author. If author contact information is available in this abstract, please feel free to contact him or her with your queries regarding this submission. Alternatively, please contact the conference host, journal, or publisher (according to the circumstance) for further details regarding this item. If a citation is listed in this record, the item has been published and is available via open-access avenues or a journal/database subscription. Contact your library for assistance in obtaining the as-published article.-
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