Department of Critical Care Medicine, Maoming People's Hospital, Maoming, Guangdong, China.
Clinical Research Center, Center of Scientific Research, Maoming People's Hospital, Maoming, Guangdong, China.
BMJ Open. 2023 Jul 30;13(7):e072897. doi: 10.1136/bmjopen-2023-072897.
Sepsis is a life-threatening immune disorder resulting from an dysregulated host response to infection. Adjuvant therapy is a valuable complement to sepsis treatment. Lipoic acid has shown potential in attenuating sepsis-induced immune dysfunction and organ injury in vivo and in vitro studies. However, clinical evidence of lipoic acid injection in sepsis treatment is lacking. Hence, we devised a randomised controlled trial to evaluate the efficacy and safety of lipoic acid injection in improving the prognosis of sepsis or septic shock patients.
A total of 352 sepsis patients are planned to be recruited from intensive care units (ICUs) at eight tertiary hospitals in China for this trial. Eligible participants will undergo randomisation in a 1:1 ratio, allocating them to either the control group or the experimental group. Both groups received routine care, with the experimental group also receiving lipoic acid injection and the control group receiving placebo. The primary efficacy endpoint is 28-day all-cause mortality. The secondary efficacy endpoints are as follows: ICU and hospital mortality, ICU and hospital stay, new acute kidney injury in ICU, demand and duration of life support, Sequential Organ Failure Assessment (SOFA)/Acute Physiology and Chronic Health Evaluation II (APACHE II) and changes from baseline (ΔSOFA/ΔApache II), arterial blood lactate (LAC) and changes from baseline (ΔLAC), blood procalcitonin, high-sensitivity C-reactive protein, interleukin-2 (IL-2), IL-4, IL-6, IL-10, tumour necrosis factor-α (TNF-α) and interferon-γ (IFN-γ) and changes from baseline on day 1 (D1), D3, D5 and D7. Clinical safety will be assessed through analysis of adverse events.
The study was approved by the Ethics Committee of Maoming People's Hospital (approval no. PJ2020MI-019-01). Informed consent will be obtained from the participants or representatives. The findings will be disseminated through academic conferences or journal publications.
ChiCTR2000039023.
败血症是一种危及生命的免疫紊乱疾病，由宿主对感染的反应失调引起。辅助治疗是败血症治疗的重要补充。硫辛酸在体内和体外研究中已显示出减轻败血症引起的免疫功能障碍和器官损伤的潜力。然而，缺乏硫辛酸注射治疗败血症的临床证据。因此，我们设计了一项随机对照试验，以评估硫辛酸注射改善败血症或感染性休克患者预后的疗效和安全性。
本试验计划在中国 8 家三级医院的重症监护病房（ICU）招募 352 例败血症患者。符合条件的参与者将按 1:1 比例随机分组，分为对照组和实验组。两组均接受常规治疗，实验组同时给予硫辛酸注射，对照组给予安慰剂。主要疗效终点为 28 天全因死亡率。次要疗效终点如下：ICU 和医院死亡率、ICU 和医院住院时间、ICU 新发急性肾损伤、生命支持的需求和持续时间、序贯器官衰竭评估（SOFA）/急性生理学和慢性健康评估 II（APACHE II）及与基线的变化（ΔSOFA/ΔApache II）、动脉血乳酸（LAC）及与基线的变化（ΔLAC）、降钙素原、高敏 C 反应蛋白、白细胞介素-2（IL-2）、IL-4、IL-6、IL-10、肿瘤坏死因子-α（TNF-α）和干扰素-γ（IFN-γ）及与基线的变化在第 1 天（D1）、D3、D5 和 D7。通过分析不良事件评估临床安全性。
该研究得到了茂名市人民医院伦理委员会的批准（批准号：PJ2020MI-019-01）。将从参与者或代表处获得知情同意。研究结果将通过学术会议或期刊发表进行传播。
ChiCTR2000039023。
