Baseline clinical characteristics of patients with sepsis
Characteristics
Total (n = 288)
P value
Tα1 group (n = 149)
Placebo group (n = 139)
Age (years)
65.1 ± 13.9
66.8 ± 12.4
0.276
Sex (male)
118 (79)
100 (72)
0.152
Pre-existing conditions
125 (84)
113 (81)
0.561
Congestive cardiomyopathy
3
4
Hypertension
69
66
Coronary heart disease
18
13
Liver disease
7
7
COPD
24
25
Diabetes
34
28
Recent trauma
7
5
Cancer
50
42
Recent surgical history
0.702
No history of surgery
77
78
Elective surgery
39
35
Emergency surgery
33
26
Other indicators of disease severity
0.201
MV
118
108
Shock
47
47
Use of vasopressor
55
46
RRT
24
13
Low dose corticoid
16
12
Blood transfusion
51
42
Acute organ dysfunctions
0.303
Pulmonary
142
132
Renal
41
34
Cardiovascular
100
81
Hematological
55
49
Hepatic
23
24
Number of acute organ dysfunctions
0.798
1
24
30
2
64
59
3
40
32
4
16
14
5
5
4
Site of infection
0.598
Lung
113
105
Abdomen
38
36
Positive blood culture
9
7
Urinary tract
2
5
Other
11
11
Result of pathogens
0.542
Gram negative
33
30
Gram positive
9
13
Fungus
15
18
Mixed
59
56
No
33
22
APACHE II score
22.4 ± 6.3
21.2 ± 7.6
0.169
C reactive protein (mg/L)
129.0 (73.9, 189.5)
114.0 (66.8, 175.5)
0.153
White blood cell (× 109/L)
14.6 (10.2, 19.9)
14.5 (11.0, 17.7)
0.526
Neutrophil (%)
86.4 (80.8, 90.7)
86.6 (80.9, 91.1)
0.772
Monocyte (%)
5.0 (2.9, 7.5)
4.9 (3.3, 7.4)
0.865
Lymphocyte (× 109/L)
0.9 (0.5, 1.5)
0.9 (0.5, 1.4)
0.909
Platelet (× 109/L)
165.0 (86.3, 253.8)
170.0 (116.0, 272.3)
0.452
Lactate (mmol/L)
2.1 (1.3, 3.1)
2.0 (1.3, 2.8)
0.419
Creatinine (μmol/L)
102.9 (71.5, 196.3)
93.0 (61.2, 180.2)
0.183
Total bilirubin (μmol/L)
14.5 (9.2, 23.6)
13.0 (8.4, 23.2)
0.375
ICU mortality
7 (14.0)
13 (13.1)
0.884
Hospital mortality
10 (20.0)
23 (23.2)
0.652
28-day mortality
8 (16.0)
19 (19.2)
0.630
ICU-free days (median, IQR)
17.8 (11.3, 20.4)
11.8 (0.9, 18.3)
0.001
MV free days (median, IQR)
21.0 (16.3, 25.5)
19.4 (10.8, 24.9)
0.275
Values are described by number (percentage), mean ± SD or median IQR. COPD: chronic obstructive pulmonary disease; RRT: renal replacement therapy; MV: mechanical ventilation
We would like to thank all of the doctors, nurses, technicians, and patients involved at the six participating hospitals for their dedication to the ETASS trial.
Author contributions
FP, YL and JW drafted the manuscript. FP, LZ and LW carried out the data analysis. BG, LL, MC, YN and LW collected and discussed the data. JW, FP and XG designed all research, interpreted data and edited the manuscript. All authors approved the final manuscript as submitted and agreed to be accountable for all aspects of the work.
Conflicts of interest
The authors declare that they have no conflicts of interest.
Ethical approval
The ETASS trial was approved by the ethics committee of the First Affiliated Hospital of Sun Yat-sen University (200815). Written informed consents were obtained from the patients or next of kin.
Consent to participate
Informed consent to participate in the study was obtained from all participants.
Consent to publication
Not applicable.
Availability of data and materials
Requests for accessing the datasets should be directed to contact the corresponding author Prof. Jianfeng Wu. The supplementary tables can be found in the Supplemental materials section.
Funding
This work was funded by Guangdong Clinical Research Center for Critical Care Medicine (2020B1111170005), by Sun Yat-sen University Clinical Research Program 5010 (2007015, 2019002), and by Program for the Natural Science Foundation of Guangdong Province (2016A030313269). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
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