BMJ Open. 2016 Jan 14;6(1):e009812. doi: 10.1136/bmjopen-2015-009812.
Acute kidney injury (AKI) is associated with increased morbidity and mortality following cardiac surgery. Data focusing on the patterns of AKI following major gastrointestinal surgery could inform quality improvement projects and clinical trials, but there is a lack of reliable evidence. This multicentre study aims to determine the incidence and impact of AKI following major gastrointestinal and liver surgery.
This prospective, collaborative, multicentre cohort study will include consecutive adults undergoing gastrointestinal resection, liver resection or reversal of ileostomy or colostomy. Open and laparoscopic procedures in elective and emergency patients will be included in the study. The primary end point will be the incidence of AKI within 7 days of surgery, identified using an adaptation of the National Algorithm for Detecting Acute Kidney Injury, which is based on the Kidney Disease Improving Global Outcomes (KDIGO) AKI guidelines. Secondary outcomes will include persistent renal dysfunction at discharge and 1 year postoperatively. The 30-day adverse event rate will be measured using the Clavien-Dindo scale. Data on factors that may predispose to the development of AKI will be collected to identify variables associated with AKI. Based on our previous collaborative studies, a minimum of 114 centres are expected to be recruited, contributing over 6500 patients in total.
This study will be registered as clinical audit at each participating hospital. The protocol will be disseminated through local and national medical student networks in the UK and Ireland.
急性肾损伤(AKI)与心脏手术后发病率和死亡率的增加相关。关注大型胃肠道手术后AKI模式的数据可为质量改进项目和临床试验提供信息,但目前缺乏可靠证据。这项多中心研究旨在确定大型胃肠道和肝脏手术后AKI的发生率及其影响。
这项前瞻性、协作性、多中心队列研究将纳入接受胃肠道切除术、肝脏切除术或回肠造口术或结肠造口术逆转的连续成年患者。择期和急诊患者的开放手术和腹腔镜手术均将纳入研究。主要终点将是术后7天内AKI的发生率,采用基于改善全球肾脏病预后组织(KDIGO)AKI指南改编的国家急性肾损伤检测算法进行识别。次要结局将包括出院时和术后1年的持续性肾功能不全。30天不良事件发生率将使用Clavien-Dindo量表进行测量。将收集可能易患AKI的因素的数据,以识别与AKI相关的变量。根据我们之前的协作研究,预计至少招募114个中心,总共贡献超过6500例患者。
本研究将在各参与医院注册为临床审计。该方案将通过英国和爱尔兰的地方和国家医学生网络进行传播。