Yiqi Huoxue Granules for Elder Pulmonary Sepsis Patients: A Protocol of a Randomized Double-blinded Clinical study
- Conditions
- sepsis
- Registration Number
- ITMCTR2024000044
- Lead Sponsor
- Guangdong Provincial Hospital of Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
(1) Meet the definition and diagnostic criteria of sepsis 3.0: refer to the definition and diagnostic criteria of sepsis 3.0 jointly issued by the American Society of Critical Care Medicine (SCCM) and the European Society of Critical Care Medicine (ESICM) in 2016: there is a definite or suspected infection, and the SOFA score is = 2.
(2) Meet the diagnostic criteria for pneumonia: community-acquired pneumonia: refer to the 2016 Guidelines for the Diagnosis and Treatment of Community-Acquired Pneumonia in Chinese Adults, hospital-acquired pneumonia: refer to the 2018 Guidelines for the Diagnosis and Treatment of Hospital-Acquired Pneumonia and Ventilator-Associated Pneumonia in Chinese Adults, and the source of sepsis infection is pneumonia;
(3) invasive mechanical ventilation therapy;
(4) Age = 65 years old and = 85 years old; Gender is not limited;
(5) Those who signed informed consent
(1) Those who are in a dying state and may die within 24 hours;
(2) Those with serious conditions requiring cardiopulmonary resuscitation;
(3) Those with cachexia in advanced malignant tumors;
(4) Those with acute coronary artery disease, such as acute myocardial infarction;
(5) Those who are allergic to the taste of traditional Chinese medicine prescribed for Yiqi Huoxue granule, or those who are allergic to constitution;
(6) pregnant or lactating women;
(7) Those who have participated in other clinical trials in the past 3 months.
(8) Other circumstances that the clinical investigator deems inappropriate to participate in the study.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Invasive mechanical ventilation duration;
- Secondary Outcome Measures
Name Time Method CD14+/HLA-DR;Sepsis-related Organ Failure Assessment score;PD-L1;oxygenation index;7 day case fatality rate;Number of days in 28 days not requiring ventilator support; Length of stay in ICU;Hospitalization days;Quick Sepsis-related Organ Failure Assessment score;WBC (white blood cell);PD-1;APACHE? score;