Sepsis
Conditions
Interventions
Treatment group:Standard treatment of sepsis and Zhusheyong Yiqifumai (freeze-dried)
Control group:Standard treatment of sepsis
Sponsors
Xiyuan Hospital, China Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 89 Years
Inclusion criteria
Inclusion criteria: 1. Meets the diagnostic criteria of sepsis and deficiency syndrome of Qi and Yin; 2. Male or female, aged 18-90 (boundary value included); 3. Subjects and/or legal guardians voluntarily participate in the study and sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Known allergy to the test drug as well as to the excipients or similar drugs, self-reported susceptibility to hypersensitivity; 2. Subjects with severe intracranial disease (intracranial arterial stenosis, intracranial infection, cerebral hemorrhage, cerebral infarction, traumatic brain injury, post-cranial surgery); 3. Including but not limited to patients with severe brain injury, after cardiopulmonary resuscitation, advanced malignant tumor, and severe primary diseases of the liver, lung, kidney, and hematopoietic system, with a very poor prognosis; 4. Patients with autoimmune diseases, immunodeficiency diseases, continuous use of immunosuppressive drugs within the last 6 months, or organ transplants; 5. Major surgery or serious trauma within the last 2 weeks; 6. Female subjects who are pregnant; 7. Participation in another clinical drug trial in the 1 month prior to the trial; 8. Poor compliance or other clinical, social, or family factors that, in the opinion of the investigator, make inclusion in the study inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Death rate;Length of ICU stay;Incidence of re-entry into ICU;Absolute lymphocyte values;TB lymphocyte subsets;Cytokine detection; | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of vasoactive drugs;Duration of mechanical ventilation;Duration of continuous renal replacement therapy;SOFA score;Quantities of fluid resuscitation;Duration of fluid resuscitation;Anxiety depression Scale;BARTHEL score;TCM syndrome score;Mean arterial pressure;Heart rate;Blood lactate;Lactate clearance rate;Detection of myocardial lesion, NT-proBNP;Blood gas analysis Rusults;Coagulation examination,TAT/PIC/TM/tPAIC;APACHEII scale;Immunoprotein assay,complement determination;24-hour urine volume;Blood routine examination, urine routine;C-reactive protein, procalcitonin;Respiratory rate;Liver and kidney function;Input and output amount;Oxygenation Index; | — |
Countries
China
Contacts
Public ContactZhixu Yang
Xiyuan Hospital, China Academy of Chinese Medical Sciences
Outcome results
None listed