Clinical trial NCT04963699: The Study of NT-proBNP Combined With HS-cTnT in Evaluating the Prognosis of Sepsis
Official title: The Study of N-terminal Pro-brain Natriuretic Peptide Combined With High-sensitivity Troponin T in Evaluating the Prognosis of Sepsis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Keywords: N-terminal pro-brain natriuretic peptide
High-sensitivity troponin T
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-07-15
Enrollment: 80
Sex: ALL
Minimum age (years): 16
Maximum age (years): 89
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with sepsis who were diagnosed and treated in our hospital from June 2016 to March 2021

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* All have clear infection through clinical examination; no acute coronary syndrome, no immunodeficiency, no tumor, etc. in the past 1 month; no pulmonary embolism or aortic dissection; no valvular heart disease, cardiomyopathy, myocarditis, etc.; no pregnant women And lactating women; no congenital heart, liver, kidney and other organ diseases.

Exclusion Criteria:

* Acute coronary syndrome, immunodeficiency, tumor, etc. in the past month; pulmonary embolism and aortic dissection; valvular heart disease, cardiomyopathy, myocarditis, etc.; pregnant and lactating women; congenital Heart, liver, kidney and other organ diseases

Primary outcomes:
measure: NT-proBNP
timeFrame: 2016.06.01-----2021.03.30
measure: hs-cTnT
timeFrame: 2016.06.01-----2021.03.30
measure: APACHEⅡ score
timeFrame: 2016.06.01-----2021.03.30
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Roche 601 Biochemical Immunoassay Instrument
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: yang xufeng, MS
role: PRINCIPAL_INVESTIGATOR
References: