the Mechanism of the Downregulation of R-spondin3 in Sepsis Induced Lung Injury
Conditions: Acute Lung Injury (ALI), Acute Respiratory Distress Syndrome (ARDS)
Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

  
Xin Hua Hospital, Shanghai Jiao Tong University School of Medicine 
 
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Research  Protocol 
 
 
 
 
 
 
TITLE: the Mechanism of the Downregulation of Dopamine Receptor in Mechanical 
Ventilation Induced Lung Injury 
 
PROTOCOL ID: XHEC-C-2020-084 
 
SPONSOR: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine 
 
INVESTIGATOR: Lai Jiang 
 
 DOCUMENT DATE: June 9, 2020 
 

  
Xin Hua Hospital, Shanghai Jiao Tong University School of Medicine 
 
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Materials and methods 
1. Patients recruitment 
Research protocol was approved by Xinhua Hospital Ethics Committee Affiliated to Shanghai 
Jiao Tong University School of Medicine. With written informed consents given by all patients, 
individual information and blood sample were collected. 
    Fifty patients who developed sepsis are considered for enrollment into the study. Inclusion 
criteria were patients with sepsis defined as SIRS combined with an infectious episode and 
dysfunction of one or more organ and age older than 18 years. SIRS is considered to be present 
when patients have more than one of the following clinical findings: Body temperature higher 
than 38°C or lower than 36°C ; Heart rate higher than 90/min; Hyperventilation evidenced by 
respiratory rate higher than 20/min or PaCO2 lower than 32 mmHg; White blood cell count 
higher than 12,000 cells/ µl or lower than 4,000/ µl . Health subjects with no previous history 
provided blood samples as controls. Exception criteria: patients younger than 18; women during 
pregnancy or lactation; being involved in other clinical subjects. Acute Physiology and Chronic 
Health Evaluation II (APACHE II) and Sequential Organ Failure Assessment (SOFA) scores 
were assessed at the time of patient enrollment.  
2. Blood sample collection and preparation:  
Blood samples were collected from patients within 24 hours after the diagnosis of sepsis and 
from the healthy volunteers.  Serum or plasma was separated by centrifugation and stored at -80℃ 
until use. R-spondin1-4 and the biomarkers of endothelial dysfunction, for example, vWF, 
VEGFR1, TM, sFLT, etc will be detected according to the instructions of manufacture. 
3. Statistical analysis 
All data were presented as mean ± SEM. Comparisons of plasma Rspos between septic patients 
and healthy controls were performed using a paired two-sided Student t test. Comparisons of 
baseline characteristics of included and excluded patients were performed using two-sided 
Student t test or chisquare test as appropriate. Correlations between Rspos and other markers were 
investigated by means of scatter plots and Spearman rank correlation coefficients. A value of 
p<0.05 was considered to indicate statistical significance. Statistical analyses were performed 
with SPSS Statistics 22.