Severe Community Acquired Pneumonia
Conditions
Interventions
Control group:0.9%NaCl 200 ml
Experimental group:Xuebijing 100ml+0.9%NaCl 100ml
Sponsors
Zhongshan Hospital Fudan Unversity
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Provide signed informed consent, aged 18 to 75 years, weight =40 kg and =100 kg, clinical symptoms suggestive of community-acquired pneumonia, acquired outside of the hospital or less than 48 hours after hospital admission, met SCAP criteria (defined by the American Thoracic Society) fulfilled three or more of the following criteria: PaO2/FiO2 ratio =250 mmHg, respiratory rate =30 breaths/min, blood urea nitrogen (BUN) >20 mg/dL, leukopenia (white blood cell count (WBC) <4000 cells/ mm3) not due to other causes, thrombocytopenia (platelet count<100,000 cells/mm3), hypothermia (core temperature <36 degree C), new onset mental confusion, receiving treatment with vasopressors at therapeutic doses after adequate fluid resuscitation, or radiographic findings on new pulmonary infiltrate(s) consistent with CAP diagnosis. Patients with pneumonia of sufficient severity requiring ICU management and patients meeting at least one of the severity criteria, such as receiving mechanical ventilatory support or septic shock with the need for vasopressors, were also included in the study)
Exclusion criteria
Exclusion criteria: Life expectancy was 48 hours or less, pregnant or lactating, diagnosed with severe primary diseases, using immunosuppressants and/or cytotoxic drugs, diagnosed with lung disease induced by obstructive lung tumors, diagnosed with psychiatric disorders, or if allergic to two or more substances. Further exclusion criteria included concurrently participating in other clinical trials within 30 days before enrollment, use of prohibited medicine within 7 days before enrollment, and a diagnosis of severe acute respiratory distress syndrome (ARDS) (if patient had multi-lobar infiltrates, a low PaO2/FiO2 ratio (<100 mmHg) and met the definition of severe ARDS, he/she was excluded), could not complete the study judged by investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pneumonia severity index (PSI) improvement rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| 28-day mortality;The time of mechanical ventilation;Total duration of ICU stay;PSI score;Sequential Organ Failure Assessment Score;Sequential Organ Failure Assessment high risk Rate;APACHEII score;APACHE II improvement Rate;SIRS improvement Rate;Lung Injury Score;Lung Injury Score improvement Rate;MODS score;The time of bacterial cultures becoming negative; | — |
Countries
China
Contacts
Public ContactBai Chunxue
Zhongshan Hospital, Fudan University
Outcome results
None listed