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Table 2 Content and points of data capture

From: Xuebijing injection in the treatment of severe pneumonia: study protocol for a randomized controlled trial

Content

Screening

Intervention

After intervention

Visit 1

Visit 2

Visit 3

Visit 4

Visit 5

Visit 6

Visit 7

Visit 8

Visit 9

Visit 10

Day

0

1

2

3

4

5

6

7

8

28

Informed consent form

Χ

         

Pregnancy test

Χ

         

Demographic information

Χ

         

Inclusion/exclusion criteria

Χ

         

Get SSID and random number

Χ

         

History of SP and treatment

Χ

         

History of medication and treatment

Χ

         

Concomitant diseases

Χ

         

Complications

Χ

Χ

Χ

Χ

Χ

Χ

Χ

Χ

Χ

 

Body weight and body mass index

Χ

       

Χ

 

Vital signs

Χ

Χ

Χ

Χ

Χ

Χ

Χ

Χ

Χ

 

Laboratory tests

Χ

   

Χ

   

Χ

 

Safety outcomes

Χ

   

Χ

   

Χ

Χ

Mean arterial pressure

Χ

Χ

Χ

Χ

Χ

Χ

Χ

Χ

Χ

 

Central venous pressure

Χ

Χ

Χ

Χ

Χ

Χ

Χ

Χ

Χ

 

Blood gas analysis

Χ

Χ

Χ

Χ

Χ

Χ

Χ

Χ

Χ

 

Mechanical ventilation parameters

Χ

Χ

Χ

Χ

Χ

Χ

Χ

Χ

Χ

 

Chest x-ray or CT scan

Χ

   

Χ

   

Χ

 

Sputum and blood culture

Χ

Χ

Χ

Χ

Χ

Χ

Χ

Χ

Χ

Χ

Record of routine treatment

 

Χ

Χ

Χ

Χ

Χ

Χ

Χ

  

Issue study drug

 

Χ

Χ

Χ

Χ

Χ

Χ

Χ

  

Record issue and recovery drug

 

Χ

Χ

Χ

Χ

Χ

Χ

Χ

  

Record adverse events

 

Χ

Χ

Χ

Χ

Χ

Χ

Χ

  

Severity-of-illness scores

Χ

   

Χ

   

Χ

 

Stage efficacy evaluation

    

Χ

   

Χ

 

Length of mechanical ventilation

Χ

Χ

Χ

Χ

Χ

Χ

Χ

Χ

Χ

 

Length of stay in ICU

Χ

Χ

Χ

Χ

Χ

Χ

Χ

Χ

Χ

 

Length of hospitalization

Χ

Χ

Χ

Χ

Χ

Χ

Χ

Χ

Χ

 

Length of antibiotic use

Χ

Χ

Χ

Χ

Χ

Χ

Χ

Χ

Χ

 

Efficacy and safety evaluation

        

Χ

 

Main treatment affecting prognosis

         

Χ

Survival follow-up

         

Χ

  1. CT computed tomography, ICU intensive care unit, SP severe pneumonia