Subcutaneous Rehydration Using Recombinant Human Hyaluronidase in Infants and Children

2.50
Hdl Handle:
http://hdl.handle.net/10755/162465
Type:
Presentation
Title:
Subcutaneous Rehydration Using Recombinant Human Hyaluronidase in Infants and Children
Abstract:
Subcutaneous Rehydration Using Recombinant Human Hyaluronidase in Infants and Children
Conference Sponsor:Emergency Nurses Association
Conference Year:2008
Author:Allen, Coburn, MD
P.I. Institution Name:Baylor College of Medicine
Title:Assistant Professor
Contact Address:6621 Fannin Street, Houston, TX, 77030, USA
Contact Telephone:(832) 824-5436
[Research Poster] Purpose: Emergency Department (ED) nurses and care providers face challenges in establishing intravenous (IV) access in dehydrated infants and children. The Increased Flow Utilizing Subcutaneously Enabled (INFUSE) Pediatric Rehydration Study is being conducted to evaluate the safety, efficacy, and ease of use of subcutaneous (SC) rehydration augmented with recombinant human hyaluronidase (rHuPH20), a spreading agent approved as an adjuvant to increase the dispersion and absorption of other injected drugs and SC fluids.

Design: Ongoing, prospective, Phase IV, open-label, multicenter trial

Setting: EDs with access to pediatric populations

Sample: Children 2 months to 10 years old with mild to moderate dehydration (1 to 5 signs on the Gorelick scale) requiring parenteral fluids. Subjects are excluded if they received adequate oral or any IV fluids immediately before enrollment; are in shock or another life-threatening situation; or have severe dehydration. Informed consent is required from the patient's legally authorized representative. Target sample size is 50.

Methodology: Patients receive a single 1 mL SC injection of rHuPH20 (150 U) through a 24-gauge angiocatheter in the upper back or other suitable region, followed by 20 mL/kg isotonic fluid over the first hour. Additional SC hydration is continued as needed. The primary efficacy measure is the percent of patients discharged from the ED to home without needing rescue therapy. Secondary measures include Gorelick score at the end of treatment, total fluid volume infused, time to discharge or transfer to hospital, change in body weight, time to first urine output, rescue therapy or readmission to the ED or hospital, and parent/caregiver satisfaction. Ease of use is evaluated in terms of the time needed for SC catheter placement and start of fluid infusion, the number of needle sticks required for SC catheterization, and the need for infusion site changes or flow rate reductions. Safety and tolerability are assessed in terms of infusion site pain, tenderness, erythema, pruritus, swelling, ecchymosis, rash, and adverse events.

Results: Early results in patients equal to or less than 3 years old receiving lactated Ringer's solution show 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 to 400 mL within the first 3 hours. The procedure is generally easy to perform.

Conclusions: In pediatric patients needing parenteral therapy, SC hydration can be a safe and effective option when augmented with rHuPH20. 2
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.titleSubcutaneous Rehydration Using Recombinant Human Hyaluronidase in Infants and Childrenen_GB
dc.identifier.urihttp://hdl.handle.net/10755/162465-
dc.description.abstract<table><tr><td colspan="2" class="item-title">Subcutaneous Rehydration Using Recombinant Human Hyaluronidase in Infants and Children</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">2008</td></tr><tr class="item-author"><td class="label">Author:</td><td class="value">Allen, Coburn, MD</td></tr><tr class="item-institute"><td class="label">P.I. Institution Name:</td><td class="value">Baylor College of Medicine</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 Street, 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><td colspan="2" class="item-abstract">[Research Poster] Purpose: Emergency Department (ED) nurses and care providers face challenges in establishing intravenous (IV) access in dehydrated infants and children. The Increased Flow Utilizing Subcutaneously Enabled (INFUSE) Pediatric Rehydration Study is being conducted to evaluate the safety, efficacy, and ease of use of subcutaneous (SC) rehydration augmented with recombinant human hyaluronidase (rHuPH20), a spreading agent approved as an adjuvant to increase the dispersion and absorption of other injected drugs and SC fluids. <br/><br/>Design: Ongoing, prospective, Phase IV, open-label, multicenter trial<br/><br/>Setting: EDs with access to pediatric populations<br/><br/>Sample: Children 2 months to 10 years old with mild to moderate dehydration (1 to 5 signs on the Gorelick scale) requiring parenteral fluids. Subjects are excluded if they received adequate oral or any IV fluids immediately before enrollment; are in shock or another life-threatening situation; or have severe dehydration. Informed consent is required from the patient's legally authorized representative. Target sample size is 50.<br/><br/>Methodology: Patients receive a single 1 mL SC injection of rHuPH20 (150 U) through a 24-gauge angiocatheter in the upper back or other suitable region, followed by 20 mL/kg isotonic fluid over the first hour. Additional SC hydration is continued as needed. The primary efficacy measure is the percent of patients discharged from the ED to home without needing rescue therapy. Secondary measures include Gorelick score at the end of treatment, total fluid volume infused, time to discharge or transfer to hospital, change in body weight, time to first urine output, rescue therapy or readmission to the ED or hospital, and parent/caregiver satisfaction. Ease of use is evaluated in terms of the time needed for SC catheter placement and start of fluid infusion, the number of needle sticks required for SC catheterization, and the need for infusion site changes or flow rate reductions. Safety and tolerability are assessed in terms of infusion site pain, tenderness, erythema, pruritus, swelling, ecchymosis, rash, and adverse events.<br/><br/>Results: Early results in patients equal to or less than 3 years old receiving lactated Ringer's solution show 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 to 400 mL within the first 3 hours. The procedure is generally easy to perform.<br/><br/>Conclusions: In pediatric patients needing parenteral therapy, SC hydration can be a safe and effective option when augmented with rHuPH20. 2</td></tr></table>en_GB
dc.date.available2011-10-27T10:28:40Z-
dc.date.issued2011-10-17en_GB
dc.date.accessioned2011-10-27T10:28:40Z-
dc.description.sponsorshipEmergency Nurses Associationen_GB
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