title: Techniques for hyaluronidase-facilitated subcutaneous fluid administration with recombinant human hyaluronidase: the increased flow utilizing subcutaneously enabled administration technique (INFUSE AT) study.
abstract: BACKGROUND
  Recombinant human hyaluronidase facilitates subcutaneous (SC) fluid delivery, but little is known about how various access sets influence ease of administration, technical challenges (TCs), or adverse events.
  
  
  METHODS
  This randomized, open-label, parallel-group trial was performed to assess the impact of catheter size (20- and 24-gauge short peripheral intravenous catheter, 27-gauge SC button), catheter material (Teflon, polyurethane), and securement method (transparent semipermeable membrane dressing [TSM], double chevron with cloth or plastic tape) on hyaluronidase-facilitated SC fluid delivery. Healthy volunteers (N = 100) were randomized to 1 of 9 access groups using a factorial design. To minimize variability, treatment was performed at a single center and standardized to 150 units of SC recombinant human hyaluronidase (HYLENEX, Baxter Healthcare Corporation) followed by 1000 mL of lactated Ringer's solution.
  
  
  RESULTS
  The first attempt at needle insertion succeeded in 98% of subjects; the median time for first catheter placement was less than 1 minute. The median infusion time was 6.8 hours. Overall, the incidence of TCs observed (catheter kinking, dislodgment, or pullout or infusion pump alarm) was low and comparable across groups (16.7%-27.3%); however, catheter kinking, dislodgment, and pullout occurred only in groups using double- chevron securement. Infusion-site reactions (pain, 20%-75%; erythema, 17%-36%; swelling, 0%-33%) were the most common adverse events. Pain was less frequent in groups using the 27-gauge SC button (27%) or the 24-gauge catheter (20%-36%) than with the 20-gauge catheter (50%-75%).
  
  
  CONCLUSIONS
  Hyaluronidase-facilitated SC fluid administration with recombinant human hyaluronidase was generally well tolerated and successfully implemented using a range of access sets. Technical challenges were not common but were further minimized with TSM securement. Infusion-site pain was mostly mild and least common with 24-gauge or smaller catheter/needles.
authors.affiliation: sandra.connolly@celerion.com
authors.forename: Sandra
authors.initials: S
authors.lastname: Connolly
authors.forename: Helen
authors.initials: H
authors.lastname: Korzemba
authors.forename: George
authors.initials: G
authors.lastname: Harb
authors.forename: Francois
authors.initials: F
authors.lastname: Lebel
authors.forename: Christine
authors.initials: C
authors.lastname: Syltevik
mesh_terms: D006801:Humans; D006821:Hyaluronoglucosaminidase / Q000008:administration & dosage*; D055104:Infusions, Subcutaneous; D011994:Recombinant Proteins / Q000008:administration & dosage
chemical_list: D011994:Recombinant Proteins; D006821:Hyaluronoglucosaminidase