Haga Taiki, Tani Masanori, Oi Tadashi, Sakihama Hiroshi, Sasaki Kyosuke, Fujiwara Naoki, Miyaji Mai, Okada Hiroshi, Itakura Ryuta, Noda Shunsuke, Wada Sho, Yamagami Yuji, Koizumi Taku, Horikawa Akito, Omori Norio, Sato Mitsuaki, Morota Junichiro, Ide Kentaro
Department of Critical Care Medicine, Osaka City General Hospital.
Department of Intensive Care Medicine, Saitama Prefectural Children's Medical Center.
Ann Clin Epidemiol. 2023 Aug 9;5(4):121-126. doi: 10.37737/ace.23016. eCollection 2023.
The use of continuous renal replacement therapy (CRRT) in critically ill children is rapidly increasing, but the standard of care has not yet been established and prognosis remains poor. To develop optimal CRRT strategies, we launched a research project generating the Japanese Pediatric CRRT registry, a multicenter registry of CRRT in Japanese pediatric intensive care units (PICUs), to investigate the actual status of CRRT in recent years in PICUs, where data are lacking.
This manuscript presents a protocol for planning a multicenter prospective registry. As of April 2023, 15 Japanese PICUs are voluntarily participating. Patients enrolled are those <16 years of age who enter the PICUs of the collaborating institutions, require CRRT, and have the guardians' consent. CRRT is defined as anticipated to be required for >24 hours, and CRRT connected to extracorporeal membrane oxygenation is also included. The registry is an online registry system managed by the University Hospital Medical Information Network. The primary outcomes are Pediatric Cerebral Performance Category Scale at PICU discharge and 6 months post-discharge (deaths included), persistent need for dialysis, and PICU readmission within 6 months. The secondary outcomes are adverse events during and immediately after CRRT initiation, and initial circuit life span.
This project will examine the differences in outcomes of CRRT in PICUs in specific patient and treatment groups and will be used to design future interventional studies. We will also aim to establish a platform for a multicenter registry study in Japanese PICUs, considering the current lack of such a platform.
连续性肾脏替代疗法(CRRT)在危重症儿童中的应用正在迅速增加,但护理标准尚未确立,预后仍然很差。为了制定最佳的CRRT策略,我们启动了一个研究项目,建立了日本儿科CRRT登记处,这是一个日本儿科重症监护病房(PICU)CRRT的多中心登记处,以调查近年来PICU中CRRT的实际情况,目前这方面的数据还很缺乏。
本手稿介绍了一项多中心前瞻性登记研究的方案。截至2023年4月,15家日本PICU自愿参与。纳入的患者为年龄<16岁、进入合作机构的PICU、需要CRRT且获得监护人同意的患者。CRRT定义为预计需要超过24小时,连接体外膜肺氧合的CRRT也包括在内。该登记处是一个由大学医院医学信息网络管理的在线登记系统。主要结局指标为PICU出院时及出院后6个月的小儿脑功能表现分类量表(包括死亡情况)、持续透析需求以及6个月内PICU再入院情况。次要结局指标为CRRT开始期间及结束后立即出现的不良事件,以及初始体外循环寿命。
该项目将研究特定患者和治疗组中PICU内CRRT结局的差异,并将用于设计未来的干预性研究。考虑到目前缺乏这样一个平台,我们还旨在建立一个日本PICU多中心登记研究的平台。