Journal Article

2% chlorhexidine gluconate aqueous versus 2% chlorhexidine gluconate in 70% isopropyl alcohol for skin disinfection prior to percutaneous central venous catheterisation: the ARCTIC randomised controlled feasibility trial

Webber, Mark A, Juszczak, Ed, Clarke, Paul, Linsell, Louise, Pattnayak, Santosh, King, Andrew, Bell, Jennifer L, Heath, Paul T, Soe, Aung, Tremlett, Catherine, Muthukumar, Priyadarsini, Harizaj, Helen, Nichols, Amy, Partlett, Christopher

2024

Overview

ObjectiveCatheter-related sepsis (CRS) is a major complication with significant morbidity and mortality. Evidence is lacking regarding the most appropriate antiseptic for skin disinfection before percutaneous central venous catheter (PCVC) insertion in preterm neonates. To inform the feasibility and design of a definitive randomised controlled trial (RCT) of two antiseptic formulations, we conducted the Antiseptic Randomised Controlled Trial for Insertion of Catheters (ARCTIC) feasibility study to assess catheter colonisation, sepsis, and skin morbidity.DesignFeasibility RCT.SettingTwo UK tertiary-level neonatal intensive care units.PatientsPreterm infants born <34 weeks’ gestation scheduled to undergo PCVC insertion.InterventionsSkin disinfection with either 2% chlorhexidine gluconate (CHG)-aqueous or 2% CHG-70% isopropyl alcohol (IPA) before PCVC insertion and at removal.Primary outcomeProportion in the 2% CHG-70% IPA arm with a colonised catheter at removal.Main feasibility outcomesRates of: (1) CRS, catheter-associated sepsis (CAS), and CRS/CAS per 1,000 PCVC days; (2) recruitment and retention; (3) data completeness.Safety outcomesDaily skin morbidity scores recorded from catheter insertion until 48 hours post-removal.Results116 babies were randomised. Primary outcome incidence was 4.1% (95% confidence interval: 0.9% to 11.5%). Overall catheter colonisation rate was 5.2% (5/97); CRS 2.3/1000 catheter days; CAS 14.8/1000 catheter days. Recruitment, retention and data completeness were good. No major antiseptic-related skin injury was reported.ConclusionsA definitive comparative efficacy trial is feasible, but the very low catheter colonisation rate would make a large-scale RCT challenging due to the very large sample size required. ARCTIC provides preliminary reassurance supporting potential safe use of 2% CHG-70% IPA and 2% CHG-aqueous in preterm neonates.Trial registration number ISRCTN82571474.

• Publisher: BMJ Publishing Group Ltd and Royal College of Paediatrics and Child Health,BMJ Publishing Group LTD,BMJ Publishing Group
• Subject: 2-Propanol / Alcohol / Anti-Infective Agents, Local / Antibiotics / Catheter-Related Infections - epidemiology / Catheter-Related Infections - prevention & control / Catheterization, Central Venous - adverse effects / Catheters / Central Venous Catheters / Chlorhexidine - analogs & derivatives / Colonization / Disinfection / Feasibility Studies / Hospitals / Humans / Infant, Newborn / Infectious Disease Medicine / Intensive care / Medical instruments / Microbiology / Morbidity / Neonatal care / Neonates / Neonatology / Newborn babies / Nosocomial infections / Original Research / Premature babies / Retention / Sepsis / Sepsis - epidemiology / Sepsis - prevention & control / Skin / Statistical analysis