RT Journal Article
SR Electronic
T1 Peripherally Inserted Central catheter iNnovation to reduce Infections and Clots (the PICNIC trial): a randomised controlled trial protocol
JF BMJ Open
JO BMJ Open
FD British Medical Journal Publishing Group
SP e042475
DO 10.1136/bmjopen-2020-042475
VO 11
IS 4
A1 Amanda J Ullman
A1 Deanne August
A1 Tricia Kleidon
A1 Rachel Walker
A1 Nicole M Marsh
A1 Andrew Bulmer
A1 Benjamin Pearch
A1 Naomi Runnegar
A1 Jessica A Schults
A1 Joanne Leema
A1 Paul Lee-Archer
A1 Cathy Biles
A1 Katrina Southam
A1 Victoria Gibson
A1 Joshua Byrnes
A1 Robert S Ware
A1 Vineet Chopra
A1 Alan Coulthard
A1 Peter Mollee
A1 Claire M Rickard
A1 Patrick N A Harris
YR 2021
UL http://bmjopen.bmj.com/content/11/4/e042475.abstract
AB Introduction Peripherally inserted central catheters (PICCs) are vital for the delivery of medical therapies, but up to 30% of PICCs are associated with complications such as deep vein thrombosis or infection. The integration of antimicrobial and hydrophobic catheter materials, and pressure-activated valves, into polyurethane PICCs are innovations designed to prevent infective and/or thrombotic complications.Methods and analysis A multicentre, parallel group, superiority randomised controlled trial with two experimental arms ((1) hydrophobic PICC (with pressure-activated valve); (2) chlorhexidine gluconate-impregnated PICC (with external clamp)) and one control group ((3) conventional polyurethane PICC (with external clamp)). Recruitment of 1098 adult and paediatric patients will take place over 2 years at three tertiary-referral hospitals in Queensland, Australia. Patients are eligible for inclusion if their PICC is to be inserted for medical treatment, with a vascular size sufficient to support a 4-Fr PICC or larger, and with informed consent. The primary outcome is PICC failure, a composite of thrombotic (venous thrombosis, breakage and occlusion) and infective complications (PICC-associated bloodstream infection and local infection). Secondary outcomes include: all-cause PICC complication; thrombotic complications; infective complications; adverse events (local or systemic reaction); PICC dwell time; patient/parent satisfaction; and healthcare costs. Differences between both intervention groups and the control group will be compared using Cox proportional hazards regression. Effect estimates will be presented as HRs with corresponding 95% CI.Ethics and dissemination Ethical approval from Queensland Health (HREC/QCHQ/48682) and Griffith University (Ref. No. 2019/094). Results will be published.Trial registration number ACTRN12619000022167.The data generated and/or analysed during the trial are not yet publicly available as the trial is ongoing. When the trial is complete, data sets will be available from the chief investigator (AJU) on reasonable request, and after agreement by ethics.