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

Linhui Hu; Xinjuan Zhou; Jinbo Huang; Yuemei He; Quanzhong Wu; Xiangwei Huang; Kunyong Wu; Guangwen Wang; Sinian Li; Xiangyin Chen; Chunbo Chen

doi:10.1136/bmjopen-2023-072897

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

BMJ Open. 2023 Jul 30;13(7):e072897. doi: 10.1136/bmjopen-2023-072897.

Authors

Linhui Hu^{1

2}, Xinjuan Zhou^{2

3}, Jinbo Huang², Yuemei He^{2

3}, Quanzhong Wu⁴, Xiangwei Huang¹, Kunyong Wu⁵, Guangwen Wang⁵, Sinian Li⁶, Xiangyin Chen⁴, Chunbo Chen⁷

Affiliations

¹ Department of Critical Care Medicine, Maoming People's Hospital, Maoming, Guangdong, China.
² Clinical Research Center, Center of Scientific Research, Maoming People's Hospital, Maoming, Guangdong, China.
³ Department of Cardiology, Maoming People's Hospital, Maoming, Guangdong, China.
⁴ Department of Surgery Intensive Care Medicine, Maoming People's Hospital, Maoming, Guangdong, China.
⁵ Center of Scientific Research, Maoming People's Hospital, Maoming, Guangdong, China.
⁶ Department of Neurocritical Care Unit, Maoming People's Hospital, Maoming, Guangdong, China.
⁷ Department of Critical Care Medicine, Shenzhen People's Hospital, The Second Clinical Medical College of Jinan University, The First Affiliated Hospital of Southern University of Science and Technology, Shenzhen, 518020, China gghccm@163.com.

Abstract

Introduction: 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.

Methods and analysis: 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.

Ethics and dissemination: 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.

Trial registration: ChiCTR2000039023.

Keywords: Adult intensive & critical care; Clinical trials; Protocols & guidelines; Randomized Controlled Trial.

Publication types

Clinical Trial Protocol
Research Support, Non-U.S. Gov't

MeSH terms

Humans
Intensive Care Units
Prognosis
Randomized Controlled Trials as Topic
Sepsis* / drug therapy
Single-Blind Method
Thioctic Acid* / therapeutic use

Substances

Thioctic Acid