Adjuvant Lipoic acid Injection in Sepsis treatment in China (ALIS study): protocol for a randomised, single-blind, placebo-controlled trial
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 s...
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2023-07-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/13/7/e072897.full |
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| author | Linhui Hu Chunbo Chen Xinjuan Zhou Jinbo Huang Yuemei He Quanzhong Wu Xiangwei Huang Kunyong Wu Guangwen Wang Sinian Li Xiangyin Chen |
| author_facet | Linhui Hu Chunbo Chen Xinjuan Zhou Jinbo Huang Yuemei He Quanzhong Wu Xiangwei Huang Kunyong Wu Guangwen Wang Sinian Li Xiangyin Chen |
| author_sort | Linhui Hu |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-12T16:16:04Z |
| format | Article |
| id | doaj.art-06c1e887b85c4577a9755604debb0c41 |
| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2024-03-12T16:16:04Z |
| publishDate | 2023-07-01 |
| publisher | BMJ Publishing Group |
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| series | BMJ Open |
| spelling | doaj.art-06c1e887b85c4577a9755604debb0c412023-08-09T02:55:06ZengBMJ Publishing GroupBMJ Open2044-60552023-07-0113710.1136/bmjopen-2023-072897Adjuvant Lipoic acid Injection in Sepsis treatment in China (ALIS study): protocol for a randomised, single-blind, placebo-controlled trialLinhui Hu0Chunbo Chen1Xinjuan Zhou2Jinbo Huang3Yuemei He4Quanzhong Wu5Xiangwei Huang6Kunyong Wu7Guangwen Wang8Sinian Li9Xiangyin Chen10Department of Critical Care Medicine, Maoming People`s Hospital, Maoming, Guangdong, ChinaThe Second School of Clinical Medicine, Southern Medical University, Guangzhou, Guangdong, ChinaClinical Research Center, Center of Scientific Research, Maoming People`s Hospital, Maoming, Guangdong, ChinaClinical Research Center, Center of Scientific Research, Maoming People`s Hospital, Maoming, Guangdong, ChinaClinical Research Center, Center of Scientific Research, Maoming People`s Hospital, Maoming, Guangdong, ChinaDepartment of Surgery Intensive Care Medicine, Maoming People`s Hospital, Maoming, Guangdong, ChinaDepartment of Critical Care Medicine, Maoming People`s Hospital, Maoming, Guangdong, ChinaCenter of Scientific Research, Maoming People`s Hospital, Maoming, Guangdong, ChinaCenter of Scientific Research, Maoming People`s Hospital, Maoming, Guangdong, ChinaDepartment of Neurocritical Care Unit, Maoming People`s Hospital, Maoming, Guangdong, ChinaDepartment of Surgery Intensive Care Medicine, Maoming People`s Hospital, Maoming, Guangdong, ChinaIntroduction 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.https://bmjopen.bmj.com/content/13/7/e072897.full |
| spellingShingle | Linhui Hu Chunbo Chen Xinjuan Zhou Jinbo Huang Yuemei He Quanzhong Wu Xiangwei Huang Kunyong Wu Guangwen Wang Sinian Li Xiangyin Chen Adjuvant Lipoic acid Injection in Sepsis treatment in China (ALIS study): protocol for a randomised, single-blind, placebo-controlled trial BMJ Open |
| title | Adjuvant Lipoic acid Injection in Sepsis treatment in China (ALIS study): protocol for a randomised, single-blind, placebo-controlled trial |
| title_full | Adjuvant Lipoic acid Injection in Sepsis treatment in China (ALIS study): protocol for a randomised, single-blind, placebo-controlled trial |
| title_fullStr | Adjuvant Lipoic acid Injection in Sepsis treatment in China (ALIS study): protocol for a randomised, single-blind, placebo-controlled trial |
| title_full_unstemmed | Adjuvant Lipoic acid Injection in Sepsis treatment in China (ALIS study): protocol for a randomised, single-blind, placebo-controlled trial |
| title_short | Adjuvant Lipoic acid Injection in Sepsis treatment in China (ALIS study): protocol for a randomised, single-blind, placebo-controlled trial |
| title_sort | adjuvant lipoic acid injection in sepsis treatment in china alis study protocol for a randomised single blind placebo controlled trial |
| url | https://bmjopen.bmj.com/content/13/7/e072897.full |
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