Techniques for Recombinant Human Hyaluronidase Enabled Subcutaneous Fluid Administration

2.50
Hdl Handle:
http://hdl.handle.net/10755/162524
Type:
Presentation
Title:
Techniques for Recombinant Human Hyaluronidase Enabled Subcutaneous Fluid Administration
Abstract:
Techniques for Recombinant Human Hyaluronidase Enabled Subcutaneous Fluid Administration


Conference Sponsor:Emergency Nurses Association
Conference Year:2009
Author:Harb, George, MD, MPH
P.I. Institution Name:Baxter Healthcare Corporation
Title:Therapeutic Area Leader, Hylenex
Contact Address:95 Spring Street, New Providence, NJ, 7974, USA
Contact Telephone:908-286-7303
Co-Authors:Edio Zampaglione, MD; Christine Syltevik
[Annual Conference Research Poster]
Purpose: Subcutaneous (SC) hydration is an option for treating mild to moderate dehydration in settings where establishing IV access is difficult or not easily accommodated. SC recombinant human hyaluronidase (rHuPH20) facilitates SC hydration by increasing dispersion and absorption of subcutaneously administered fluids. The Increased Flow Utilizing Subcutaneously Enabled Administration Technique (INFUSE AT) study is being conducted to evaluate various techniques for rHuPH20 enabled SC fluid administration.

Design: Randomized, parallel group, open-label, 2-center trial

Setting: In-patient clinical research unit

Sample: Healthy adult volunteers aged 18 to 60 years inclusive who provide written informed consent and agree to abstain from all fluid intake for 12 hours prior to study initiation. Target sample size is 90 subjects.

Methodology: Volunteers are randomly assigned to 1 of 9 different SC infusion techniques, with variation in angiocatheter gauge (20 or 24), length of angiocatheter (0.75 or 1.00 inch), type of tubing (Teflon or polyurethane), and securement method (Tegaderm or tape double chevron). One treatment group receives a 9 mm long, 27 gauge button delivery system for SC infusion. All infusion sets are placed in the anterior thigh midway between the anterior iliac crest and the cephalad border of the patella. All volunteers receive a single 1 mL SC injection of rHuPH20 (150 U), immediately followed in the same location by SC infusion of 1000 mL Lactated Ringer's solution delivered via infusion pump over 7 to 10 hours. The bolus rate is 200 mL/h for the first 2 hours, then 125 mL/h until infusion is complete. Technical challenges are evaluated based on time to first report and frequency of events including, but not limited to, catheter kinking, dislodgement or pull out, infusion pump beeping or failure, and interventions to maintain infusion (such as re-taping, catheter manipulation). Ease of use is evaluated based on total time to start fluid infusion, number of needle sticks/catheterization attempts, and infusion site changes, interruptions, or flow rate reductions. Safety and tolerability are assessed on Days 1, 2, and 7, based on infusion site reactions, change in thigh circumference, and adverse events.

Results: One hundred volunteers (62 males, 38 females; mean age, 34.5 years) were randomized (10 to 12 subjects per treatment group). TCs were reported in 21 subjects; proportion with =1 TC was comparable across treatment groups. The most frequent TC was pump alarm (9% to 27% of subjects across treatment groups). Median time from infusion start to first TC report ranged from 1.3 to 5.2 hours across groups. Successful SC access was achieved on first attempt in all but 2 subjects (2 attempts each). Across groups, median time to catheter placement was 9.0 to 48.5 seconds. TC-induced flow interruptions occurred in 20 subjects and flow reduction in 1 subject. Mean interruption duration/individual was 1.0 to 6.5 minutes. At least 1 AE was reported in 46% to 91% of subjects. AEs were mild, except in 2 subjects who had moderate to severe AEs; 1 serious AE (ureteral calculus) was not considered drug-related.
Conclusions: TCs, reported in up to 27% of subjects in treatment groups, were comparable across SC administration techniques.

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.titleTechniques for Recombinant Human Hyaluronidase Enabled Subcutaneous Fluid Administrationen_GB
dc.identifier.urihttp://hdl.handle.net/10755/162524-
dc.description.abstract<table><tr><td colspan="2" class="item-title">Techniques for Recombinant Human Hyaluronidase Enabled Subcutaneous Fluid Administration<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">Harb, George, MD, MPH</td></tr><tr class="item-institute"><td class="label">P.I. Institution Name:</td><td class="value">Baxter Healthcare Corporation</td></tr><tr class="item-author-title"><td class="label">Title:</td><td class="value">Therapeutic Area Leader, Hylenex</td></tr><tr class="item-address"><td class="label">Contact Address:</td><td class="value">95 Spring Street, New Providence, NJ, 7974, USA</td></tr><tr class="item-phone"><td class="label">Contact Telephone:</td><td class="value">908-286-7303</td></tr><tr class="item-email"><td class="label">Email:</td><td class="value">george_harb@baxter.com</td></tr><tr class="item-co-authors"><td class="label">Co-Authors:</td><td class="value">Edio Zampaglione, MD; Christine Syltevik</td></tr><tr><td colspan="2" class="item-abstract">[Annual Conference Research Poster] <br/>Purpose: Subcutaneous (SC) hydration is an option for treating mild to moderate dehydration in settings where establishing IV access is difficult or not easily accommodated. SC recombinant human hyaluronidase (rHuPH20) facilitates SC hydration by increasing dispersion and absorption of subcutaneously administered fluids. The Increased Flow Utilizing Subcutaneously Enabled Administration Technique (INFUSE AT) study is being conducted to evaluate various techniques for rHuPH20 enabled SC fluid administration.<br/><br/>Design: Randomized, parallel group, open-label, 2-center trial<br/><br/>Setting: In-patient clinical research unit<br/><br/>Sample: Healthy adult volunteers aged 18 to 60 years inclusive who provide written informed consent and agree to abstain from all fluid intake for 12 hours prior to study initiation. Target sample size is 90 subjects.<br/><br/>Methodology: Volunteers are randomly assigned to 1 of 9 different SC infusion techniques, with variation in angiocatheter gauge (20 or 24), length of angiocatheter (0.75 or 1.00 inch), type of tubing (Teflon or polyurethane), and securement method (Tegaderm or tape double chevron). One treatment group receives a 9 mm long, 27 gauge button delivery system for SC infusion. All infusion sets are placed in the anterior thigh midway between the anterior iliac crest and the cephalad border of the patella. All volunteers receive a single 1 mL SC injection of rHuPH20 (150 U), immediately followed in the same location by SC infusion of 1000 mL Lactated Ringer's solution delivered via infusion pump over 7 to 10 hours. The bolus rate is 200 mL/h for the first 2 hours, then 125 mL/h until infusion is complete. Technical challenges are evaluated based on time to first report and frequency of events including, but not limited to, catheter kinking, dislodgement or pull out, infusion pump beeping or failure, and interventions to maintain infusion (such as re-taping, catheter manipulation). Ease of use is evaluated based on total time to start fluid infusion, number of needle sticks/catheterization attempts, and infusion site changes, interruptions, or flow rate reductions. Safety and tolerability are assessed on Days 1, 2, and 7, based on infusion site reactions, change in thigh circumference, and adverse events.<br/><br/>Results: One hundred volunteers (62 males, 38 females; mean age, 34.5 years) were randomized (10 to 12 subjects per treatment group). TCs were reported in 21 subjects; proportion with =1 TC was comparable across treatment groups. The most frequent TC was pump alarm (9% to 27% of subjects across treatment groups). Median time from infusion start to first TC report ranged from 1.3 to 5.2 hours across groups. Successful SC access was achieved on first attempt in all but 2 subjects (2 attempts each). Across groups, median time to catheter placement was 9.0 to 48.5 seconds. TC-induced flow interruptions occurred in 20 subjects and flow reduction in 1 subject. Mean interruption duration/individual was 1.0 to 6.5 minutes. At least 1 AE was reported in 46% to 91% of subjects. AEs were mild, except in 2 subjects who had moderate to severe AEs; 1 serious AE (ureteral calculus) was not considered drug-related.<br/>Conclusions: TCs, reported in up to 27% of subjects in treatment groups, were comparable across SC administration techniques.<br/><br/></td></tr></table>en_GB
dc.date.available2011-10-27T10:29:39Z-
dc.date.issued2011-10-17en_GB
dc.date.accessioned2011-10-27T10:29:39Z-
dc.description.sponsorshipEmergency Nurses Associationen_GB
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