Department of General, Transplant and Liver Surgery, Medical University of Warsaw, Banacha 1A, 02-097, Warsaw, Poland.
Department of Epidemiology and Biostatistics, Medical University of Warsaw, Oczki 3, 02-007, Warsaw, Poland.
BMC Med. 2023 Feb 13;21(1):51. doi: 10.1186/s12916-023-02741-w.
Despite inconsistent evidence, international guidelines underline the importance of perioperative hyperoxygenation in prevention of postoperative infections. Further, data on safety and efficacy of this method in liver transplant setting are lacking. The aim was to evaluate efficacy and safety of postoperative hyperoxygenation in prophylaxis of infections after liver transplantation.
In this randomized controlled trial, patients undergoing liver transplantation were randomly assigned to either 28% or 80% fraction of inspired oxygen (FiO) for 6 postoperative hours. Infections occurring during 30-day post-transplant period were the primary outcome measure. Secondary outcome measures included 90-day mortality, 90-day severe morbidity, 30-day pulmonary complications, durations of hospital and intensive care unit stay, and 5-day postoperative bilirubin concentration, alanine and aspartate transaminase activity, and international normalized ratio (INR) (clinicatrials.gov NCT02857855).
A total of 193 patients were included and randomized to 28% (n = 99) and 80% (n = 94) FiO. With similar patient, operative, and donor characteristics in both groups, infections occurred in 34.0% (32/94) of patients assigned to 80% FiO as compared to 23.2% (23/99) of patients assigned to 28% FiO (p = 0.112). Patients randomized to 80% FiO more frequently developed severe complications (p = 0.035), stayed longer in the intensive care unit (p = 0.033), and had higher bilirubin concentration over first 5 post-transplant days (p = 0.043). No significant differences were found regarding mortality, duration of hospital stay, pulmonary complications, and 5-day aspartate and alanine transaminase activity and INR.
Postoperative hyperoxygenation should not be used for prophylaxis of infections after liver transplantation due to the lack of efficacy.
ClinicalTrials.gov NCT02857855. Registered 7 July 2016.
尽管证据不一致，但国际指南强调了围手术期高氧血症在预防术后感染中的重要性。此外，关于这种方法在肝移植环境中的安全性和有效性的数据尚缺乏。本研究旨在评估肝移植术后高氧血症预防感染的疗效和安全性。
在这项随机对照试验中，接受肝移植的患者被随机分配到 28%或 80%吸入氧分数（FiO），持续 6 个术后小时。30 天移植后期间发生的感染是主要观察指标。次要观察指标包括 90 天死亡率、90 天严重发病率、30 天肺部并发症、住院和重症监护病房停留时间以及术后第 5 天胆红素浓度、丙氨酸转氨酶和天冬氨酸转氨酶活性和国际标准化比值（INR）（clinicaltrials.gov NCT02857855）。
共纳入 193 例患者，并随机分为 28%（n=99）和 80%（n=94）FiO 组。两组患者的患者、手术和供体特征相似，80%FiO 组发生感染的患者比例为 34.0%（32/94），而 28%FiO 组为 23.2%（23/99）（p=0.112）。随机分配至 80%FiO 组的患者更频繁地发生严重并发症（p=0.035），在重症监护病房停留时间更长（p=0.033），且术后第 5 天胆红素浓度更高（p=0.043）。两组间死亡率、住院时间、肺部并发症、5 天天门冬氨酸转氨酶和丙氨酸转氨酶活性及 INR 无显著差异。
由于缺乏疗效，肝移植后不应用高氧血症预防感染。
ClinicalTrials.gov NCT02857855。2016 年 7 月 7 日注册。
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