Yiqi Huoxue Granules for Elder Pulmonary Sepsis Patients: A Protocol of a Randomized Double-blinded Clinical study

Category Primary study
Registry of TrialsITMCTR
Year 2024
INTERVENTION: Control Group(Western medicine conventional treatment plus Yiqi Huoxue placebo granule)):The conventional treatment of Western medicine plus placebo, which is based on the 2016 Sepsis 3.0 guidelines, the 2014 Chinese Guidelines for the Treatment of Severe Sepsis/Septic Shock, and the Chinese Guidelines for the Emergency Treatment of Sepsis/Septic Shock (2018), including control of the primary disease, initial aggressive fluid resuscitation, antibiotics, maintenance of hemodynamic stability, and other organ function support.;Experimental group(Yiqi Huoxue granule plus Western medicine conventional treatment group):On the basis of the Western medical intervention program, the addition of Yiqi and blood scattering granules (1 dose per day, oral administration in the morning and evening divided into 2 times/nasal feeding; Treatment course: 7 days); CONDITION: sepsis PRIMARY OUTCOME: Invasive mechanical ventilation duration; SECONDARY OUTCOME: 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; INCLUSION CRITERIA: (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
Epistemonikos ID: 5e24ced143e4fc87140de44e82d4c038964b9b29
First added on: Aug 28, 2024