Adjuvant Lipoic acid Injection in Sepsis treatment in China (ALIS study): protocol for a randomised, single-blind, placebo-controlled trial

Hu, Linhui1,2; Zhou, Xinjuan2,3; Huang, Jinbo2; He, Yuemei2,3; Wu, Quanzhong4; Huang, Xiangwei1; Wu, Kunyong5; Wang, Guangwen5; Li, Sinian6; Chen, Xiangyin4; Chen, Chunbo7

2023-07-01

10.1136/bmjopen-2023-072897

BMJ OPEN   Impact Factor & Quartile

2044-6055

IntroductionSepsis 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. Methods and analysisA 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 (& UDelta;SOFA/& UDelta;Apache II), arterial blood lactate (LAC) and changes from baseline (& UDelta;LAC), blood procalcitonin, high-sensitivity C-reactive protein, interleukin-2 (IL-2), IL-4, IL-6, IL-10, tumour necrosis factor-& alpha; (TNF-& alpha;) and interferon-& gamma; (IFN-& gamma;) and changes from baseline on day 1 (D1), D3, D5 and D7. Clinical safety will be assessed through analysis of adverse events. Ethics and disseminationThe 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.

Clinical trials Adult intensive & critical care Randomized Controlled Trial Protocols & guidelines

SCI

English

Corresponding

Office of Talent Work Leading Team in Maoming[MaoRenCaiBan [2020]24] ; Guangzhou Science and Technology Program[201803010058] ; National Natural Science Foundation of China[82172162] ; Major Program of Summit Project, Guangdong Province High-level Hospital Construction Project of Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences[DFJH2020028] ; Emergent Science and Technology Project for Prevention and Treatment of Novel Coronavirus Pneumonia[2020YJ01] ; High -level Hospital Construction Research Project of Maoming People's Hospital[zx2020017] ; Excellent Young Talents Project of Maoming People's Hospital[SY2021005] ; Medical Research Fund of Guangdong Province[B2022246] ; Special Science and Technology Fund of Maoming City[2021KJZXZJYX003]

General & Internal Medicine

Medicine, General & Internal

WOS:001042144300036

BMJ PUBLISHING GROUP

Web of Science

1.Maoming Peoples Hosp, Dept Crit Care Med, Maoming, Guangdong, Peoples R China
2.Maoming Peoples Hosp, Clin Res Ctr, Ctr Sci Res, Maoming, Guangdong, Peoples R China
3.Maoming Peoples Hosp, Dept Cardiol, Maoming, Guangdong, Peoples R China
4.Maoming Peoples Hosp, Dept Surg Intens Care Med, Maoming, Guangdong, Peoples R China
5.Maoming Peoples Hosp, Ctr Sci Res, Maoming, Guangdong, Peoples R China
6.Maoming Peoples Hosp, Dept Neurocrit Care Unit, Maoming, Guangdong, Peoples R China
7.Southern Univ Sci & Technol, Jinan Univ, Shenzhen Peoples Hosp, Affiliated Hosp,Dept Crit Care Med,Clin Med Coll, Shenzhen 518020, Peoples R China

Hu, Linhui,Zhou, Xinjuan,Huang, Jinbo,et al. Adjuvant Lipoic acid Injection in Sepsis treatment in China (ALIS study): protocol for a randomised, single-blind, placebo-controlled trial[J]. BMJ OPEN,2023,13(7).

Hu, Linhui.,Zhou, Xinjuan.,Huang, Jinbo.,He, Yuemei.,Wu, Quanzhong.,...&Chen, Chunbo.(2023).Adjuvant Lipoic acid Injection in Sepsis treatment in China (ALIS study): protocol for a randomised, single-blind, placebo-controlled trial.BMJ OPEN,13(7).

Hu, Linhui,et al."Adjuvant Lipoic acid Injection in Sepsis treatment in China (ALIS study): protocol for a randomised, single-blind, placebo-controlled trial".BMJ OPEN 13.7(2023).