Recombinant Human Hyaluronidase Enabled Subcutaneous Rehydration in Pediatric Patients

2.50
Hdl Handle:
http://hdl.handle.net/10755/162523
Type:
Presentation
Title:
Recombinant Human Hyaluronidase Enabled Subcutaneous Rehydration in Pediatric Patients
Abstract:
Recombinant Human Hyaluronidase Enabled Subcutaneous Rehydration in Pediatric Patients


Conference Sponsor:Emergency Nurses Association
Conference Year:2009
Author:Hahn, Barry, MD, FACEP
P.I. Institution Name:Staten Island University Hospital
Title:Research Director
Contact Address:Dept. of Emergency Medicine, 475 Seaview Ave., Staten Island, NY, 10305, USA
Contact Telephone:718-226-6033
[Annual Conference Research Poster]
Purpose: Subcutaneous (SC) rehydration is an option for dehydrated infants and children, in situations where establishing intravenous (IV) access is challenging. Recombinant human hyaluronidase (rHuPH20) is a United States Food and Drug Administration (FDA)-approved adjuvant that increases dispersion and absorption of injectables from the subcutaneous space. The Increased Flow Utilizing Subcutaneously Enabled (INFUSE) Pediatric Rehydration Study is being conducted to compare the safety, efficacy, and ease of use of rHuPH20 enabled SC hydration versus IV fluid administration.

Design: Ongoing, prospective, phase IV, randomized, stratified, parallel group, open-label trial

Setting: Emergency departments with access to pediatric patients or inpatient pediatric units

Sample: Children aged 1 month to <3 years with mild to moderate dehydration (Gorelick dehydration scores 1-6) who require parenteral fluids. Excluded are patients who require IV access for another indication, are in shock or another life-threatening situation, or exhibit severe dehydration (Gorelick dehydration scores >6). Informed consent is required from the patient's legally authorized representative. The main objective is to demonstrate that rHuPH20 enabled SC administration of fluids can be given safely and effectively in clinically-appropriate volumes no less than that delivered IV. The target sample size is 148 evaluable patients.

Methodology: Patients are stratified based on body weight (<10 kg or >10 kg), and dehydration severity (Gorelick score 1-2 or 3-6), then randomized (1:1 ratio) to receive isotonic fluid rehydration via SC administration with rHuPH20 or via IV, without rHuPH20. The rHuPH20 enabled SC group first receives a single 1 mL SC injection of rHuPH20 (150 U) through an angiocatheter in the upper back or other suitable region, immediately followed by fluid infusion. All patients are given 20 mL/kg isotonic fluid over the first hour and additional fluid as needed up to 72 hours. The primary efficacy measure is total fluid volume administered at a single infusion site. Secondary measures include percentage (%) of patients successfully hydrated, and % achieving a maximum flow rate >2 mL/min. Ease of use is evaluated based on total time to start fluid infusion; the number of needle sticks/catheterization attempts; and infusion site change or flow rate reduction. Safety and tolerability are evaluated on Days 1, 2, and 7 based on pain assessments, infusion site reactions, adverse events, and vital signs.

Results: An interim data analysis was conducted on 74 subjects (37 randomized to SC; 37 randomized to IV), mean age (standard deviation [SD]) was 1.98 (1.56) years. The primary efficacy outcome, mean total volume (SD) infused over a single site, was 374 (292.1) mL for SC versus 491 (645.3) mL for IV; mean total fluid volume adjusted by duration of infusion was 445 mL for SC versus 419 for IV. Providers considered 92% of patients successfully rehydrated via the randomized route of administration with SC versus 76% with IV. The SC procedure was considered by providers as easy to perform in 97.3% of patients in the SC group versus 67.6% in the IV group, and parent/caregivers reported they were very satisfied or satisfied with the study procedure in 95% of patients in the SC group versus 73% in the IV group. All AEs were mild to moderate in severity and rHuPH20 was generally safe and well tolerated.

Conclusions: Preliminary results revealed that rHuPH20-facilitated SC infusions were safe and resulted in a higher percentage of patients who were successfully hydrated compared with IV infusions. Duration adjusted mean volume of fluids infused was comparable for both routes of administration.


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 Enabled Subcutaneous Rehydration in Pediatric Patientsen_GB
dc.identifier.urihttp://hdl.handle.net/10755/162523-
dc.description.abstract<table><tr><td colspan="2" class="item-title">Recombinant Human Hyaluronidase Enabled Subcutaneous Rehydration in Pediatric Patients<br/><br/><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">2009</td></tr><tr class="item-author"><td class="label">Author:</td><td class="value">Hahn, Barry, MD, FACEP</td></tr><tr class="item-institute"><td class="label">P.I. Institution Name:</td><td class="value">Staten Island University Hospital</td></tr><tr class="item-author-title"><td class="label">Title:</td><td class="value">Research Director</td></tr><tr class="item-address"><td class="label">Contact Address:</td><td class="value">Dept. of Emergency Medicine, 475 Seaview Ave., Staten Island, NY, 10305, USA</td></tr><tr class="item-phone"><td class="label">Contact Telephone:</td><td class="value">718-226-6033</td></tr><tr class="item-email"><td class="label">Email:</td><td class="value">barry_hahn@yahoo.com</td></tr><tr><td colspan="2" class="item-abstract">[Annual Conference Research Poster] <br/>Purpose: Subcutaneous (SC) rehydration is an option for dehydrated infants and children, in situations where establishing intravenous (IV) access is challenging. Recombinant human hyaluronidase (rHuPH20) is a United States Food and Drug Administration (FDA)-approved adjuvant that increases dispersion and absorption of injectables from the subcutaneous space. The Increased Flow Utilizing Subcutaneously Enabled (INFUSE) Pediatric Rehydration Study is being conducted to compare the safety, efficacy, and ease of use of rHuPH20 enabled SC hydration versus IV fluid administration.<br/><br/>Design: Ongoing, prospective, phase IV, randomized, stratified, parallel group, open-label trial<br/><br/>Setting: Emergency departments with access to pediatric patients or inpatient pediatric units<br/><br/>Sample: Children aged 1 month to &lt;3 years with mild to moderate dehydration (Gorelick dehydration scores 1-6) who require parenteral fluids. Excluded are patients who require IV access for another indication, are in shock or another life-threatening situation, or exhibit severe dehydration (Gorelick dehydration scores &gt;6). Informed consent is required from the patient's legally authorized representative. The main objective is to demonstrate that rHuPH20 enabled SC administration of fluids can be given safely and effectively in clinically-appropriate volumes no less than that delivered IV. The target sample size is 148 evaluable patients.<br/><br/>Methodology: Patients are stratified based on body weight (&lt;10 kg or &gt;10 kg), and dehydration severity (Gorelick score 1-2 or 3-6), then randomized (1:1 ratio) to receive isotonic fluid rehydration via SC administration with rHuPH20 or via IV, without rHuPH20. The rHuPH20 enabled SC group first receives a single 1 mL SC injection of rHuPH20 (150 U) through an angiocatheter in the upper back or other suitable region, immediately followed by fluid infusion. All patients are given 20 mL/kg isotonic fluid over the first hour and additional fluid as needed up to 72 hours. The primary efficacy measure is total fluid volume administered at a single infusion site. Secondary measures include percentage (%) of patients successfully hydrated, and % achieving a maximum flow rate &gt;2 mL/min. Ease of use is evaluated based on total time to start fluid infusion; the number of needle sticks/catheterization attempts; and infusion site change or flow rate reduction. Safety and tolerability are evaluated on Days 1, 2, and 7 based on pain assessments, infusion site reactions, adverse events, and vital signs.<br/><br/>Results: An interim data analysis was conducted on 74 subjects (37 randomized to SC; 37 randomized to IV), mean age (standard deviation [SD]) was 1.98 (1.56) years. The primary efficacy outcome, mean total volume (SD) infused over a single site, was 374 (292.1) mL for SC versus 491 (645.3) mL for IV; mean total fluid volume adjusted by duration of infusion was 445 mL for SC versus 419 for IV. Providers considered 92% of patients successfully rehydrated via the randomized route of administration with SC versus 76% with IV. The SC procedure was considered by providers as easy to perform in 97.3% of patients in the SC group versus 67.6% in the IV group, and parent/caregivers reported they were very satisfied or satisfied with the study procedure in 95% of patients in the SC group versus 73% in the IV group. All AEs were mild to moderate in severity and rHuPH20 was generally safe and well tolerated.<br/><br/>Conclusions: Preliminary results revealed that rHuPH20-facilitated SC infusions were safe and resulted in a higher percentage of patients who were successfully hydrated compared with IV infusions. Duration adjusted mean volume of fluids infused was comparable for both routes of administration.<br/><br/><br/></td></tr></table>en_GB
dc.date.available2011-10-27T10:29:38Z-
dc.date.issued2011-10-17en_GB
dc.date.accessioned2011-10-27T10:29:38Z-
dc.description.sponsorshipEmergency Nurses Associationen_GB
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