目的:导管相关性脓毒症(CRS)是一种主要并发症,具有显著的发病率和死亡率。在早产儿经皮中心静脉导管(PCVC)插入之前,缺乏最合适的防腐剂进行皮肤消毒的证据。为了说明两种抗菌制剂的确定性随机对照试验(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。
方法:可行性RCT。
方法:两个英国三级新生儿重症监护病房。
方法:妊娠34周以下的早产儿计划进行PCVC插入。
方法:在插入PCVC之前和取出时,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。
方法:拔除时带有定植导管的2%CHG-70%IPA臂的比例。
■以下比率:(1)CRS,导管相关性脓毒症(CAS),和CRS/CAS每1000个PCVC日;(2)招聘和保留;(3)数据的完整性。
■从导管插入到取出后48小时记录的每日皮肤发病率评分。
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);CRS2.3/1000导管天数;CAS14.8/1000导管天数。招聘,保留率和数据完整性良好.没有报告与防腐剂相关的严重皮肤损伤。
结论:确定的比较疗效试验是可行的,但非常低的导管定植率将使大规模RCT具有挑战性,因为需要非常大的样本量.ARCTIC提供了初步保证,支持早产新生儿可能安全使用2%CHG-70%IPA和2%CHG水溶液。
背景:ISRCTN82571474。
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.
METHODS: Feasibility RCT.
METHODS: Two UK tertiary-level neonatal intensive care units.
METHODS: Preterm infants born <34 weeks\' gestation scheduled to undergo PCVC insertion.
METHODS: Skin disinfection with either 2% chlorhexidine gluconate (CHG)-aqueous or 2% CHG-70% isopropyl alcohol (IPA) before PCVC insertion and at removal.
METHODS: Proportion in the 2% CHG-70% IPA arm with a colonised catheter at removal.
UNASSIGNED: Rates of: (1) CRS, catheter-associated sepsis (CAS), and CRS/CAS per 1,000 PCVC days; (2) recruitment and retention; (3) data completeness.
UNASSIGNED: 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.
BACKGROUND: ISRCTN82571474.