About this trial
Sepsis is a life-threatening organ dysfunction caused by the body's dysfunctional response to infection, most patients require treatment in the ICU, and is the leading cause of death worldwide. Over the years, the development of new drugs for the treatment of sepsis has failed without significant benefit in reducing mortality, and there is currently no effective drug treatment. Therefore, sepsis is a serious disease threatening the life and health of patients, causing a huge burden to society, and is a major problem in the medical field.
The pathogenesis of sepsis is complicated, and immune imbalance is the key mechanism. Suppression of host immune function may be the root cause of the increase in the long-term mortality of sepsis. Bidirectional immune regulation may be an important treatment plan to improve the survival rate and quality of life of sepsis patients. In recent years, the contribution of traditional Chinese medicine to sepsis has been highly valued at home and abroad. The treatment of sepsis by traditional Chinese medicine mainly plays the role of bidirectional immune regulation by dispelling the evil and supporting the right. Our team has achieved some results in the diagnosis and treatment of sepsis by using traditional Chinese medicine. Supported by National Natural Science Foundation of China (81774070). The team also found that magnolol can inhibit intestinal mucosal inflammation in sepsis, which was also supported by the National Natural Science Foundation of China (82174178). The team of Qhuang scholars inherit the academic experience of Zhu Liangchun, the master of Chinese medicine, warm and hot disease need not be limited to the law of wei, qi, ying, blood transmission, that is, the disease can be solved both outside and inside, breaking the three bans of warm and cold disease. On the basis of inheriting Zhu Liangchun's academic theory, the author put forward the early treatment rule of "truncation and reversal", and used to cleanse the "poison" and "save Yin" in the early stage of sepsis to quickly truncate the malignant development trend of sepsis. In the COVID-19 epidemic, we have found that patients with COVID-19 sepsis have "acute deficiency syndrome" in the early stage of clinical syndrome, which is an important factor leading to death. The clinical efficacy and mechanism of "Shenhuang Granules" in sepsis caused by non-novel coronavirus infection such as bacteria need to be further studied.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years old
Meet the diagnostic criteria of sepsis 3.0 guidelines
Sign informed consent.
Disqualifiers
Liver or kidney single SOFA score ≥3 points of liver and kidney dysfunction
Death is expected within 48 hours, or SOFA≥15 points, or APACHE II ≥30 points, or the patient refuses active treatment
Patients with allergic reactions to traditional Chinese medicine
Patients treated with chemotherapy or radiotherapy or high-dose immunosuppressants within the last 1 month
Trial design
Parallel
Treatments tested in this trial
shenhuang granule
DrugTraditional Chinese medicine compound "Shenhuang Granules" is developed by Professor Fang Bangjiang, a scholar in the team of Qi-Huang, which is composed of ginseng, rhubarb, dandelion, etc., with the effect of Fuzheng Guben, clearing heat and detoxification, promoting qi and promoting blood and detumification.
placebo
DrugPlacebo was provided by Tianjin Hongri Pharmaceutical Co., LTD., and was given orally or nasally (through gastric tube or intestinal tube) after dissolution of 100ml warm water (temperature about 40°) in 1 package twice a day.
Treatment groups
Trial outcomes
Primary outcomes
28-day mortality rate
The proportion of deaths due to illness within 28 days after treatment began
Secondary outcomes
Total length of stay and ICU stay
Total length of stay and length of stay in ICU
Total hospitalization costs and ICU hospitalization costs
The patient's total hospitalization costs and hospitalization costs in the ICU
Overall mortality and ICU mortality
The proportion of patients who died during their total hospital stay and the proportion of patients who died during their ICU stay were included
28 days cumulative no mechanical ventilation time
The total time the patient spent without mechanical ventilation (such as a ventilator) in the 28 days following the start of treatment.
Other outcomes
Blood routine test
It mainly includes WBC, percentage of neutrophils,The percentages of white blood cells and neutrophils represent inflammation, with higher values indicating higher inflammation.
C-reactive protein
C-reactive protein on behalf of the inflammation, the higher the value, the higher the inflammatory conditions.
Procalcitonin
Procalcitonin, the degree of its increase is positively correlated with the degree of infection. Used in the identification of bacteria and viruses, to monitor the severity of the infection, is used to evaluate the therapeutic effect and prognosis of infection.
TNF-α
It is one of the cytokines involved in the inflammatory response and is used to evaluate the therapeutic effect and prognosis of infection.
Sponsors and contacts
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The First Affiliated Hospital of Zhejiang Chinese Medical University
Lead sponsor
Zhejiang University
Collaborator
Red Cross Hospital, Hangzhou, China
Collaborator
Ningbo Hospital of Traditional Chinese Medicine
Collaborator