Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04963699 |
| Other study ID # |
2021-0317 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 26, 2021 |
| Est. completion date |
June 9, 2021 |
Study information
| Verified date |
June 2016 |
| Source |
Second Affiliated Hospital, School of Medicine, Zhejiang University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
To study the clinical value of combined detection of plasma N-terminal pro-brain natriuretic
peptide (NT-proBNP) and high-sensitivity troponin T (hs-cTnT) in assessing the prognosis of
patients with sepsis. Methods Seventy-three patients with sepsis who were diagnosed and
treated in our hospital from June 2016 to March 2021 were divided into general sepsis group
and severe sepsis group. According to different outcomes, they were divided into survival
Group and death group, to explore the relationship between plasma NT-proBNP, hs-cTnT levels
and APACHEⅡ score and the value of prognostic evaluation of sepsis.
Description:
1.1 Information The 73 patients with sepsis who were diagnosed and treated in our hospital
from June 2016 to March 2021 were selected as the research objects. All of them had clear
infections through clinical examination; there were no acute coronary syndromes, no
immunodeficiency diseases, and no immunodeficiency diseases in the past month. No tumors,
etc.; no pulmonary embolism and aortic dissection; no valvular heart disease, cardiomyopathy,
myocarditis, etc.; no pregnant women and lactating women; no congenital heart, liver, kidney
and other organ diseases. The diagnostic criteria of sepsis refer to the "Guidelines for the
Emergency Treatment of Sepsis/Septic Shock in China (2018)" [5]. The patients were divided
into general sepsis group (30 cases) and severe sepsis group (43 cases) according to the
severity of their illness. The severe sepsis group included severe sepsis (35 cases) and
septic shock (8 cases). , Select the population (40 cases) in our hospital for physical
examination during the same period as the healthy control group.
1.2 Method 1.2.1 Testing equipment: All patients with sepsis will take 3ml of cubital venous
blood when they are admitted to the hospital and place them in a green-head tube containing
lithium heparin anticoagulant produced by BD in the United States. After centrifugation at
3000 r/min for 10 minutes, they will be tested immediately; health In the control group, 3ml
of cubital venous blood was drawn on an empty stomach in the morning of the physical
examination, placed in a lithium heparin anticoagulation tube, centrifuged at 3000 r/min for
10 minutes, and the test was completed within 2 hours. Choose Roche cobas e 601
electrochemiluminescence immunoassay analyzer to detect blood NT-pro BNP and hs-cTnT. Mindray
BC 6900 blood cell analyzer detects white blood cell count, Beckman Coulter 5831 automatic
biochemical analyzer detects C-reactive protein; all operations are performed in strict
accordance with the reagent instructions.
1.2.2 Observation indicators Patients with sepsis undergo acute physiological and chronic
health assessment (APACHE II score) within 24 hours after diagnosis.
1.3 Statistical processing SPSS 23.0 software was used for data statistical analysis,
measurement data application (x ± s) description, non-parametric test Mann-Whitney U test was
used for comparison between groups; plasma NT-proBNP and hs-cTnT were analyzed by rank
correlation analysis The correlation between the level and the APACHEⅡ score was analyzed,
and the Spearman rank correlation coefficient was used to describe the correlation.
