Department of Anaesthesiology, UMC Utrecht, Utrecht, The Netherlands
Department of Intensive Care Medicine, UMC Utrecht, Utrecht, The Netherlands.
BMJ Open. 2023 Apr 19;13(4):e068970. doi: 10.1136/bmjopen-2022-068970.
Although elective surgery is generally safe, some procedures remain associated with an increased risk of complications. Improved preoperative risk stratification and earlier recognition of these complications may ameliorate postoperative recovery and improve long-term outcomes. The perioperative longitudinal study of complications and long-term outcomes (PLUTO) cohort aims to establish a comprehensive biorepository that will facilitate research in this field. In this profile paper, we will discuss its design rationale and opportunities for future studies.
Patients undergoing elective intermediate to high-risk non-cardiac surgery are eligible for enrolment. For the first seven postoperative days, participants are subjected to daily bedside visits by dedicated observers, who adjudicate clinical events and perform non-invasive physiological measurements (including handheld spirometry and single-channel electroencephalography). Blood samples and microbiome specimens are collected at preselected time points. Primary study outcomes are the postoperative occurrence of nosocomial infections, major adverse cardiac events, pulmonary complications, acute kidney injury and delirium/acute encephalopathy. Secondary outcomes include mortality and quality of life, as well as the long-term occurrence of psychopathology, cognitive dysfunction and chronic pain.
Enrolment of the first participant occurred early 2020. During the inception phase of the project (first 2 years), 431 patients were eligible of whom 297 patients consented to participate (69%). Observed event rate was 42% overall, with the most frequent complication being infection.
The main purpose of the PLUTO biorepository is to provide a framework for research in the field of perioperative medicine and anaesthesiology, by storing high-quality clinical data and biomaterials for future studies. In addition, PLUTO aims to establish a logistical platform for conducting embedded clinical trials.
NCT05331118.
尽管择期手术通常是安全的，但某些手术仍存在并发症风险增加的问题。改善术前风险分层和更早识别这些并发症可能会改善术后恢复并改善长期结局。围手术期并发症和长期结局的纵向研究（PLUTO）队列旨在建立一个综合的生物标本库，从而为该领域的研究提供便利。在本简介论文中，我们将讨论其设计原理和未来研究的机会。
接受择期中高危非心脏手术的患者有资格入组。在术后的前 7 天，参与者每天都会接受专门观察人员的床边访视，观察人员会判断临床事件并进行非侵入性生理测量（包括手持式肺活量计和单通道脑电图）。在预选时间点采集血液样本和微生物组标本。主要研究结局为术后医院获得性感染、主要不良心脏事件、肺部并发症、急性肾损伤和谵妄/急性脑病的发生。次要结局包括死亡率和生活质量，以及长期发生的精神病理学、认知功能障碍和慢性疼痛。
首个参与者的入组于 2020 年初开始。在项目启动阶段（前 2 年），共有 431 名患者符合入组条件，其中 297 名患者同意参与（69%）。总体观察到的事件发生率为 42%，最常见的并发症是感染。
PLUTO 生物标本库的主要目的是通过储存高质量的临床数据和生物材料，为围手术期医学和麻醉学领域的研究提供框架，并为未来的研究建立一个逻辑上的临床试验平台。
NCT05331118。
