Tomazini Bruno Martins, Veiga Thabata Silva, Santos Renato Hideo Nakagawa, Campos Viviane Bezerra, Tokunaga Samira Martins, Santos Elton Sousa, Barbante Leticia Galvão, Maia Renato da Costa, Negrelli Karina Leal, Valeis Nanci, Santucci Eliana Vieira, Laranjeira Ligia Nasi, Medrado Fernando Azevedo, Lisboa Thiago Costa, Besen Bruno Adler Maccagnan Pinheiro, Nassar Junior Antônio Paulo, Veiga Viviane Cordeiro, Pereira Adriano José, Cavalcanti Alexandre Biasi
HCor Research Institute, HCor-Hospital do Coração - São Paulo (SP), Brazil.
Brazilian Research in Intensive Care Network (BRICNet) - São Paulo (SP), Brazil.
Crit Care Sci. 2024 Sep 27;36:e20240053en. doi: 10.62675/2965-2774.20240053-en. eCollection 2024.
Critically ill patients are at increased risk of health care-associated infections due to various devices (central line-associated bloodstream infection, catheter-associated urinary tract infection, and ventilator-associated pneumonia), which pose a significant threat to this population. Among several strategies, daily bathing with chlorhexidine digluconate, a water-soluble antiseptic, has been studied as an intervention to decrease the incidence of health care-associated infections in the intensive care unit; however, its ability to reduce all health care-associated infections due to various devices is unclear. We designed the Daily Chlorhexidine Bath for Health Care Associated Infection Prevention (CLEAN-IT) trial to assess whether daily chlorhexidine digluconate bathing reduces the incidence of health care-associated infections in critically ill patients compared with soap and water bathing.
The CLEAN-IT trial is a multicenter, open-label, cluster randomized crossover clinical trial. All adult patients admitted to the participating intensive care units will be included in the trial. Each cluster (intensive care unit) will be randomized to perform either initial chlorhexidine digluconate bathing or soap and water bathing with crossover for a period of 3 to 6 months, depending on the time of each center's entrance to the study, with a 1-month washout period between chlorhexidine digluconate bathing and soap and water bathing transitions. The primary outcome is the incidence of health care-associated infections due to devices. The secondary outcomes are the incidence of each specific health care-associated infection, rates of microbiological cultures positive for multidrug-resistant pathogens, antibiotic use, intensive care unit and hospital length of stay, and intensive care unit and hospital mortality.
The CLEAN-IT trial will be used to study feasible and affordable interventions that might reduce the health care-associated infection burden in critically ill patients.
重症患者因各种器械（中心静脉导管相关血流感染、导尿管相关尿路感染和呼吸机相关性肺炎）而发生医疗相关感染的风险增加，这对该人群构成了重大威胁。在多种策略中，使用葡萄糖酸洗必泰（一种水溶性防腐剂）进行每日沐浴已作为一种干预措施进行研究，以降低重症监护病房医疗相关感染的发生率；然而，其降低因各种器械导致的所有医疗相关感染的能力尚不清楚。我们设计了“每日洗必泰沐浴预防医疗相关感染（CLEAN-IT）试验”，以评估与用肥皂和水沐浴相比，每日使用葡萄糖酸洗必泰沐浴是否能降低重症患者医疗相关感染的发生率。
CLEAN-IT试验是一项多中心、开放标签、整群随机交叉临床试验。所有入住参与试验的重症监护病房的成年患者都将纳入该试验。每个整群（重症监护病房）将被随机分配进行初始葡萄糖酸洗必泰沐浴或用肥皂和水沐浴，并交叉进行3至6个月，具体取决于每个中心进入研究的时间，在葡萄糖酸洗必泰沐浴和肥皂和水沐浴转换之间有1个月的洗脱期。主要结局是器械相关医疗相关感染的发生率。次要结局是每种特定医疗相关感染的发生率、耐多药病原体微生物培养阳性率、抗生素使用情况、重症监护病房和医院住院时间以及重症监护病房和医院死亡率。
CLEAN-IT试验将用于研究可能减轻重症患者医疗相关感染负担的可行且经济实惠的干预措施。
