2%氯己定-70%异丙醇与10%聚维酮碘用于早产儿中心静脉置管前穿刺部位清洁的随机对照试验
2% chlorhexidine-70% isopropyl alcohol versus 10% povidone-iodine for insertion site cleaning before central line insertion in preterm infants: a randomised trial.
作者信息
Kieran Emily A, O'Sullivan Anne, Miletin Jan, Twomey Anne R, Knowles Susan J, O'Donnell Colm Patrick Finbarr
机构信息
Department of Neonatology, The National Maternity Hospital, Dublin, Ireland.
National Children's Research Centre, Dublin, Ireland.
出版信息
Arch Dis Child Fetal Neonatal Ed. 2018 Mar;103(2):F101-F106. doi: 10.1136/archdischild-2016-312193. Epub 2017 Oct 26.
OBJECTIVE
To determine whether 2% chlorhexidine gluconate-70% isopropyl alcohol (CHX-IA) is superior to 10% aqueous povidone-iodine (PI) in preventing catheter-related blood stream infection (CR-BSI) when used to clean insertion sites before placing central venous catheters (CVCs) in preterm infants.
DESIGN
Randomised controlled trial.
SETTING
Two neonatal intensive care units (NICUs).
PATIENTS
Infants <31 weeks' gestation who had a CVC inserted.
INTERVENTIONS
Insertion site was cleaned with CHX-IA or PI. Caregivers were not masked to group assignment.
MAIN OUTCOME MEASURES
Primary outcome was CR-BSI determined by one microbiologist who was masked to group assignment. Secondary outcomes included skin reactions to study solution and thyroid dysfunction.
RESULTS
We enrolled 304 infants (CHX-IA 148 vs PI 156) in whom 815 CVCs (CHX-IA 384 vs PI 431) were inserted and remained in situ for 3078 (CHX-IA 1465 vs PI 1613) days. We found no differences between the groups in the proportion of infants with CR-BSI (CHX-IA 7% vs PI 5%, p=0.631), the proportion of CVCs complicated by CR-BSI or the rate of CR-BSI per 1000 catheter days. Skin reaction rates were low (<1% CVC insertion episodes) and not different between the groups. More infants in the PI group had raised thyroid-stimulating hormone levels and were treated with thyroxine (CHX-IA 0% vs PI 5%, p=0.003).
CONCLUSIONS
We did not find a difference in the rate of CR-BSI between preterm infants treated with CHX-IA and PI, and more infants treated with PI had thyroid dysfunction. However, our study was not adequately powered to detect a difference in our primary outcome and a larger trial is required to confirm our findings.
TRIAL REGISTRATION
This study was registered with the EU clinical trials register before the first patient was enrolled (Eudract 2011-002962-19). (https://www.clinicaltrialsregister.eu).
目的
确定在早产儿放置中心静脉导管（CVC）前，使用2%葡萄糖酸氯己定-70%异丙醇（CHX-IA）清洁穿刺部位，在预防导管相关血流感染（CR-BSI）方面是否优于10%聚维酮碘水溶液（PI）。
设计
随机对照试验。
地点
两个新生儿重症监护病房（NICU）。
患者
孕周<31周且插入CVC的婴儿。
干预措施
用CHX-IA或PI清洁穿刺部位。护理人员未对分组情况设盲。
主要观察指标
主要结局为CR-BSI，由一名对分组情况设盲的微生物学家判定。次要结局包括对研究溶液的皮肤反应和甲状腺功能障碍。
结果
我们纳入了304例婴儿（CHX-IA组148例 vs PI组156例），其中插入815根CVC（CHX-IA组384根 vs PI组431根），并留置3078天（CHX-IA组1465天 vs PI组1613天）。我们发现两组之间CR-BSI婴儿比例（CHX-IA组7% vs PI组5%，p = 0.631）、发生CR-BSI的CVC比例或每1000导管日的CR-BSI发生率无差异。皮肤反应率较低（<1%的CVC插入事件），且两组之间无差异。PI组更多婴儿促甲状腺激素水平升高并接受甲状腺素治疗（CHX-IA组0% vs PI组5%，p = 0.003）。
结论
我们未发现CHX-IA和PI治疗的早产儿之间CR-BSI发生率存在差异，且更多接受PI治疗的婴儿出现甲状腺功能障碍。然而，我们的研究在检测主要结局差异方面的效能不足，需要更大规模的试验来证实我们的发现。
试验注册
本研究在首例患者入组前已在欧盟临床试验注册库注册（Eudract 2011-002962-19）。（https://www.clinicaltrialsregister.eu）
Zotero 插件