Objective Catheter-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. Design Feasibility RCT. Setting Two UK tertiary-level neonatal intensive care units. Patients Preterm infants born <34 weeks’ gestation scheduled to undergo PCVC insertion. Interventions Skin disinfection with either 2% chlorhexidine gluconate (CHG)-aqueous or 2% CHG-70% isopropyl alcohol (IPA) before PCVC insertion and at removal. Primary outcome Proportion in the 2% CHG-70% IPA arm with a colonised catheter at removal. Main feasibility outcomes Rates of: (1) CRS, catheter-associated sepsis (CAS), and CRS/CAS per 1,000 PCVC days; (2) recruitment and retention; (3) data completeness. Safety outcomes Daily skin morbidity scores recorded from catheter insertion until 48 hours post-removal. Results 116 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. Conclusions A 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][1]. Data are available upon reasonable request. Reasonable requests for access to the data that support the findings of this study will be considered by contacting the corresponding author. [1]: /external-ref?link_type=ISRCTN&access_num=ISRCTN82571474

中文翻译：

---

经皮中心静脉导管插入术前使用 2% 葡萄糖酸氯己定水溶液与 2% 葡萄糖酸氯己定溶于 70% 异丙醇进行皮肤消毒：ARCTIC 随机对照可行性试验

目的 导管相关性脓毒症（CRS）是一种具有显着发病率和死亡率的主要并发症。对于早产儿经皮中心静脉导管 (PCVC) 插入前皮肤消毒最合适的消毒剂缺乏证据。为了告知两种抗菌制剂的明确随机对照试验 (RCT) 的可行性和设计，我们进行了导管插入抗菌随机对照试验 (ARCTIC) 可行性研究，以评估导管定植、脓毒症和皮肤发病率。设计可行性RCT。设置两个英国三级新生儿重症监护病房。患者 妊娠 <34 周出生的早产儿计划接受 PCVC 插入。干预措施 在插入 PCVC 之前和取出时，使用 2% 葡萄糖酸氯己定 (CHG) 水溶液或 2% CHG-70% 异丙醇 (IPA) 进行皮肤消毒。主要结果 2% CHG-70% IPA 组中拔除时带有定植导管的比例。主要可行性结果： (1) 每 1,000 PCVC 天 CRS、导管相关脓毒症 (CAS) 和 CRS/CAS 发生率；(2) 招聘和保留；(3)数据完整性。安全结果 每日记录从导管插入到拔除后 48 小时的皮肤发病率评分。结果 116 名婴儿被随机分组​​。主要结局发生率为 4.1%（95% 置信区间：0.9% 至 11.5%）。总体导管定植率为 5.2% (5/97)；CRS 2.3/1000 导管日；CAS 14.8/1000 导管天数。招聘、保留和数据完整性都很好。没有报告与消毒剂相关的重大皮肤损伤。结论 明确的比较疗效试验是可行的，但由于需要非常大的样本量，非常低的导管定植率将使大规模随机对照试验具有挑战性。ARCTIC 提供了初步保证，支持 2% CHG-70% IPA 和 2% CHG 水剂在早产儿中的潜在安全使用。试用注册号 [ISRCTN82571474][1]。数据可根据合理要求提供。对于获取支持本研究结果的数据的合理请求，将通过联系相应作者予以考虑。[1]: /external-ref?link_type=ISRCTN&access_num=ISRCTN82571474