NCT04963699

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 26, 2021

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 2, 2021

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

June 9, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 9, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 15, 2021

Completed
Last Updated

July 15, 2021

Status Verified

June 1, 2016

Enrollment Period

7 days

First QC Date

June 9, 2021

Last Update Submit

July 13, 2021

Conditions

Keywords

N-terminal pro-brain natriuretic peptideHigh-sensitivity troponin T

Outcome Measures

Primary Outcomes (3)

  • NT-proBNP

    NT-proBNP is used as an aid to diagnose and monitor mild cardiac dysfunction in individuals suspected of having congestive heart failure. Compared with BNP, NT-proBNP has a longer half-life, better stability, and higher plasma concentration. , Has superiority in predicting myocardial function. Studies have found that NT-proBNP can be used as an important indicator for the prognosis of sepsis with impaired cardiac function and sepsis.The higher the plasma concentration of NT-proBNP, the worse the prognosis.

    2016.06.01-----2021.03.30

  • hs-cTnT

    hs-cTnT is an independent prognostic marker that can predict the short-term, mid-term and even long-term outcomes of patients with acute coronary syndrome (ACS). Patients with sepsis often have different degrees of damage to myocardial cells, and their plasma hs-cTnT concentration will also increase to different degrees.

    2016.06.01-----2021.03.30

  • APACHEⅡ score

    During the diagnosis and treatment of sepsis, the APACHE II score can be used to assess the severity of the patient's condition, and is also of important value for the patient's prognostic effect. The higher the score, the more severe the condition.

    2016.06.01-----2021.03.30

Eligibility Criteria

Age16 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with sepsis who were diagnosed and treated in our hospital from June 2016 to March 2021

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Roche 601 Biochemical Immunoassay Instrument

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • yang xufeng, MS

    Second Affiliated Hospital, School of Medicine, Zhejiang University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2021

First Posted

July 15, 2021

Study Start

May 26, 2021

Primary Completion

June 2, 2021

Study Completion

June 9, 2021

Last Updated

July 15, 2021

Record last verified: 2016-06

Locations