脓毒症患者高氧血症的影响——一项多中心随机临床试验的事后分析

Effects of hyperoxemia in patients with sepsis - A post-hoc analysis of a multicentre randomized clinical trial.

作者信息

Catalisano G, Ippolito M, Blanda A, Meessen J, Giarratano A, Todesco N, Bonato V, Restuccia F, Montomoli J, Fiore G, Grasselli G, Caironi P, Latini R, Cortegiani A

机构信息

Department of Surgical, Oncological and Oral Science (Di.Chir.On.S.), University of Palermo, Italy.

Department of Anaesthesia, Intensive Care and Emergency, University Hospital Policlinico Paolo Giaccone, Italy.

出版信息

Pulmonology. 2025 Dec 31;31(1):2416784. doi: 10.1016/j.pulmoe.2023.02.005. Epub 2024 Oct 24.

DOI:10.1016/j.pulmoe.2023.02.005

PMID:36907813

Abstract

BACKGROUND

Administration of supplemental oxygen is a life-saving treatment in critically ill patients. Still, optimal dosing remains unclear during sepsis. The aim of this post-hoc analysis was to assess the association between hyperoxemia and 90-day mortality in a large cohort of septic patients.

METHODS

This is a post-hoc analysis of the Albumin Italian Outcome Sepsis (ALBIOS) randomized controlled trial (RCT). Patients with sepsis who survived the first 48 h since randomization were included and stratified into two groups according to their average PaO levels during the first 48 h (PaO ). The cut-off value was established at 100 mmHg (average PaO >100 mmHg: hyperoxemia group; PaO≤100: normoxemia group). The primary outcome was 90-day mortality.

RESULTS

1632 patients were included in this analysis (661 patients in the hyperoxemia group, 971 patients in the normoxemia group). Concerning the primary outcome, 344 (35.4%) patients in the hyperoxemia group vs. 236 (35.7%) in the normoxemia group had died within 90 days from randomization ( = 0.909). No association was found after adjusting for confounders (HR 0.87; CI [95%] 0.736-1.028, = 0.102) or after excluding patients with hypoxemia at enrollment, patients with lung infection or including post-surgical patients only. Conversely, we found an association between lower risk of 90-day mortality and hyperoxemia in the subgroup including patients who had the lung as primary site of infection (HR 0.72; CI [95%] 0.565-0.918). Mortality at 28 days, ICU mortality, incidence of acute kidney injury, use of renal replacement therapy, days to suspension of vasopressor or inotropic agents, and resolution of primary and secondary infections did not differ significantly. Duration of mechanical ventilation and length of stay in ICU were significantly longer in patients with hyperoxemia.

CONCLUSIONS

In a post-hoc analysis of a RCT enrolling septic patients, hyperoxemia as average PaO>100 mmHg during the first 48 h was not associated with patients' survival.

摘要

背景

给予补充氧气是危重症患者的一种挽救生命的治疗方法。然而，脓毒症期间的最佳剂量仍不明确。这项事后分析的目的是评估一大群脓毒症患者中高氧血症与90天死亡率之间的关联。

方法

这是对白蛋白意大利脓毒症结局（ALBIOS）随机对照试验（RCT）的事后分析。纳入自随机分组后存活48小时的脓毒症患者，并根据其在最初48小时内的平均动脉血氧分压（PaO）水平分为两组。临界值设定为100 mmHg（平均PaO >100 mmHg：高氧血症组；PaO≤100：正常氧血症组）。主要结局是90天死亡率。

结果

本分析纳入了1632例患者（高氧血症组661例，正常氧血症组971例）。关于主要结局，高氧血症组344例（35.4%）患者与正常氧血症组236例（35.7%）患者在随机分组后90天内死亡（P = 0.909）。在调整混杂因素后未发现关联（风险比0.87；95%置信区间[CI] 0.736 - 1.028，P = 0.102），或者在排除入组时存在低氧血症的患者、肺部感染患者或仅纳入术后患者后也未发现关联。相反，在包括肺部为主要感染部位的患者亚组中，我们发现高氧血症与90天死亡率风险较低之间存在关联（风险比0.72；95% CI 0.565 - 0.918）。28天死亡率、重症监护病房（ICU）死亡率、急性肾损伤发生率、肾脏替代治疗的使用、血管升压药或正性肌力药物停用天数以及原发性和继发性感染的缓解情况均无显著差异。高氧血症患者的机械通气时间和ICU住院时间明显更长。