高剂量硒对心脏手术患者术后器官功能障碍和死亡率的影响：SUSTAIN CSX 随机临床试验。

Effect of High-Dose Selenium on Postoperative Organ Dysfunction and Mortality in Cardiac Surgery Patients: The SUSTAIN CSX Randomized Clinical Trial.

机构信息

University of Ottawa Heart Institute, Ottawa, Ontario, Canada.

Department of Anaesthesiology, Intensive Care, Emergency, and Pain Medicine, University Hospital Wuerzburg, Wuerzburg, Germany.

出版信息

JAMA Surg. 2023 Mar 1;158(3):235-244. doi: 10.1001/jamasurg.2022.6855.

DOI:10.1001/jamasurg.2022.6855

PMID:36630120

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9857635/

Abstract

IMPORTANCE

Selenium contributes to antioxidative, anti-inflammatory, and immunomodulatory pathways, which may improve outcomes in patients at high risk of organ dysfunctions after cardiac surgery.

OBJECTIVE

To assess the ability of high-dose intravenous sodium selenite treatment to reduce postoperative organ dysfunction and mortality in cardiac surgery patients.

DESIGN, SETTING, AND PARTICIPANTS: This multicenter, randomized, double-blind, placebo-controlled trial took place at 23 sites in Germany and Canada from January 2015 to January 2021. Adult cardiac surgery patients with a European System for Cardiac Operative Risk Evaluation II score-predicted mortality of 5% or more or planned combined surgical procedures were randomized.

INTERVENTIONS

Patients were randomly assigned (1:1) by a web-based system to receive either perioperative intravenous high-dose selenium supplementation of 2000 μg/L of sodium selenite prior to cardiopulmonary bypass, 2000 μg/L immediately postoperatively, and 1000 μg/L each day in intensive care for a maximum of 10 days or placebo.

MAIN OUTCOMES AND MEASURES

The primary end point was a composite of the numbers of days alive and free from organ dysfunction during the first 30 days following cardiac surgery.

RESULTS

A total of 1416 adult cardiac surgery patients were analyzed (mean [SD] age, 68.2 [10.4] years; 1043 [74.8%] male). The median (IQR) predicted 30-day mortality by European System for Cardiac Operative Risk Evaluation II score was 8.7% (5.6%-14.9%), and most patients had combined coronary revascularization and valvular procedures. Selenium did not increase the number of persistent organ dysfunction-free and alive days over the first 30 postoperative days (median [IQR], 29 [28-30] vs 29 [28-30]; P = .45). The 30-day mortality rates were 4.2% in the selenium and 5.0% in the placebo group (odds ratio, 0.82; 95% CI, 0.50-1.36; P = .44). Safety outcomes did not differ between the groups.

CONCLUSIONS AND RELEVANCE

In high-risk cardiac surgery patients, perioperative administration of high-dose intravenous sodium selenite did not reduce morbidity or mortality. The present data do not support the routine perioperative use of selenium for patients undergoing cardiac surgery.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT02002247.

摘要

重要性

硒有助于抗氧化、抗炎和免疫调节途径，这可能改善心脏手术后器官功能障碍高危患者的预后。

目的

评估高剂量静脉注射亚硒酸钠治疗降低心脏手术患者术后器官功能障碍和死亡率的能力。

设计、地点和参与者：这是一项多中心、随机、双盲、安慰剂对照试验，于 2015 年 1 月至 2021 年 1 月在德国和加拿大的 23 个地点进行。入选的是欧洲心脏手术风险评估系统 II 评分预测死亡率为 5%或更高的成年心脏手术患者，或计划联合手术的患者。

干预措施

患者通过基于网络的系统随机（1:1）分配接受围手术期静脉内高剂量硒补充，在体外循环前给予 2000μg/L 亚硒酸钠，术后立即给予 2000μg/L，在重症监护期间每天给予 1000μg/L，最多 10 天或安慰剂。

主要结局和测量指标

主要终点是心脏手术后 30 天内存活且无器官功能障碍天数的复合指标。

结果

共分析了 1416 例成年心脏手术患者（平均[标准差]年龄 68.2[10.4]岁；1043[74.8%]为男性）。欧洲心脏手术风险评估系统 II 评分预测的 30 天死亡率中位数（IQR）为 8.7%（5.6%-14.9%），大多数患者行冠状动脉血运重建术和瓣膜手术。硒并不能增加术后前 30 天无持续器官功能障碍和存活天数（中位数[IQR]，29[28-30]与 29[28-30]；P=0.45）。硒组 30 天死亡率为 4.2%，安慰剂组为 5.0%（比值比，0.82；95%置信区间，0.50-1.36；P=0.44）。两组间安全性结局无差异。