Department of Anaesthesiology, Intensive Care and Pain management, St. Antonius Hospital, Nieuwegein, Netherlands
Department of Anaesthesiology, Intensive Care and Emergency Medicine, University Medical Centre Utrecht, Utrecht, Netherlands.
BMJ Open. 2024 Jun 11;14(6):e078307. doi: 10.1136/bmjopen-2023-078307.
Postoperative complications increase mortality, disability and costs. Advanced understanding of the risk factors for postoperative complications is needed to improve surgical outcomes. This paper discusses the rationale and profile of the BIGPROMISE (biomarkers to guide perioperative management and improve outcome in high-risk surgery) cohort, that aims to investigate risk factors, pathophysiology and outcomes related to postoperative complications.
Adult patients undergoing major surgery in two tertiary teaching hospitals. Clinical data and blood samples are collected before surgery, at the end of surgery and on the first, second and third postoperative day. At each time point a panel of cardiovascular, inflammatory, renal, haematological and metabolic biomarkers is assessed. Aliquots of plasma, serum and whole blood of each time point are frozen and stored. Data on severe complications are prospectively collected during 30 days after surgery. Functional status is assessed before surgery and after 120 days using the WHO Disability Assessment Schedule (WHODAS) 2.0. Mortality is followed up until 2 years after surgery.
The first patient was enrolled on 8 October 2021. Currently (1 January 2024) 3086 patients were screened for eligibility, of whom 1750 (57%) provided informed consent for study participation. Median age was 66 years (60; 73), 28% were female, and 68% of all patients were American Society of Anaesthesiologists (ASA) physical status class 3. Most common types of major surgery were cardiac (49%) and gastro-intestinal procedures (26%). The overall incidence of 30-day severe postoperative complications was 16%.
By the end of the recruitment phase, expected in 2026, approximately 3000 patients with major surgery will have been enrolled. This cohort allows us to investigate the role of pathophysiological perioperative processes in the cause of postoperative complications, and to discover and develop new biomarkers to improve risk stratification for adverse postoperative outcomes.
NCT05199025.
术后并发症会增加死亡率、残疾率和医疗成本。为了改善手术效果，我们需要深入了解术后并发症的风险因素。本文讨论了 BIGPROMISE（生物标志物指导高危手术围手术期管理和改善预后）队列的基本原理和概况，该队列旨在研究与术后并发症相关的风险因素、病理生理学和结局。
在两家三级教学医院接受大手术的成年患者。在术前、手术结束时以及术后第 1、2 和 3 天采集临床数据和血液样本。在每个时间点评估心血管、炎症、肾脏、血液和代谢生物标志物的综合指标。每个时间点的血浆、血清和全血等分样被冷冻并储存。术后 30 天内前瞻性收集严重并发症的数据。在术前和术后 120 天使用世界卫生组织残疾评估量表（WHODAS）2.0 评估功能状态。术后 2 年内随访死亡率。
首例患者于 2021 年 10 月 8 日入组。目前（2024 年 1 月 1 日），对 3086 名患者进行了入选资格筛查，其中 1750 名（57%）患者同意参加研究。中位年龄为 66 岁（60；73），28%为女性，所有患者中 68%为美国麻醉医师协会（ASA）身体状况 3 级。最常见的大手术类型是心脏（49%）和胃肠手术（26%）。30 天内严重术后并发症的总发生率为 16%。
预计在 2026 年招募阶段结束时，将有大约 3000 名接受大手术的患者入组。该队列使我们能够研究围手术期病理生理过程在术后并发症发生中的作用，并发现和开发新的生物标志物来改善不良术后结局的风险分层。
NCT05199025。
