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Efficacy of Xuebijing Injection for Sepsis (EXIT-SEP): protocol for a randomised controlled trial
  1. Songqiao Liu1,
  2. Chen Yao2,
  3. Junhua Zhang3,
  4. Yi Yang1,
  5. Haibo Qiu1
  6. On behalf of the EXIT-SEP Investigators
  1. 1Department of Critical Care Medicine, School of Medicine, Zhongda Hospital, Southeast University, Nanjing, China
  2. 2Medical Statistics Office, Peking University First Hospital, Beijing, China
  3. 3Evidence-Based Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin, China
  1. Correspondence to Dr Haibo Qiu; haiboq2000{at}163.com

Abstract

Introduction Sepsis is a major challenge with high incidence and is associated with high mortality worldwide. Current management of sepsis remains mainly supportive except for treatment with antibiotics. Both basic research and clinical investigation have shown that the Chinese herbal-derived therapeutic Xuebijing (XBJ) injection is beneficial for patients with sepsis. However, the quality of evidence supporting the therapeutic use of XBJ in sepsis is limited. The aim of this trial is to evaluate the Efficacy of Xuebijing Injection for Sepsis, compared with a placebo, on the outcome of patients with sepsis in the intensive care unit (ICU).

Methods and analysis In this multicentre, blinded randomised controlled trial, we are recruiting a total of 1800 subjects who met Sepsis 3.0 criteria. Subjects will be randomised (1:1) to receive XBJ, every 12 hours for 5 days or a matching placebo and usual care. The primary outcome is 28 days all-cause mortality. Secondary outcomes will be the improvement of Sequential Organ Failure Assessment scores, the improvement of the Acute Physiology and Chronic Health Evaluation II score, duration of mechanical ventilation, mortality in ICU and duration of stay in the ICU. Investigators, participants and statisticians will be blinded to the allocated treatment.

Ethics and dissemination This trial has been approved by all ethics committees of the centres that will participate in this trial. The findings of the study will be disseminated in peer-reviewed journals and present at conferences. Once this study is complete, the results of this trial may help provide evidence-based recommendations for complementary therapeutic options for patients with sepsis.

Trial registration number NCT03238742 and ChiCTR-IPR-17012713.

  • Xuebijing injection
  • sepsis
  • randomised controlled trial
  • protocol

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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Footnotes

  • Contributors HQ designed the study, drafted the manuscript, edited the manuscript, supervised the study and obtained study funding. SL designed the study, and drafted and edited the manuscript. YY drafted and edited the manuscript. CY designed the study and reviewed the manuscript. JZ edited the manuscript and provided study supervision. The investigators of the EXIT-SEP have participated in the discussion of the protocol and reviewed the manuscript for important intellectual content. All authors have read and approved the final manuscript.

  • Funding This trial was supported by the Development Center for Medical Science and Technology, National Health and Family Planning Commission of the People’s Republic of China (WK-2016-HR-03).

  • Disclaimer The funder had no role in the design of the protocol, the conduction of the trial, or the analyses or reporting of the data.

  • Competing interests None declared.

  • Patient consent for publication Not required.

  • Ethics approval This study has been approved by the Ethics Committee of Zhongda Hospital, Southeast University (reference number: 2017ZDSYLL025-P01), on 17 May 2017.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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