SepsisNCT04963699
The Study of NT-proBNP Combined With HS-cTnT in Evaluating the Prognosis of Sepsis
An observational study of Sepsis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 16 to 89 years
- Conditions the study is for
- Sepsis
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 26 May 2021to 9 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 89 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with sepsis who were diagnosed and treated in our hospital from June 2016 to March 2021
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Roche 601 Biochemical Immunoassay Instrument
Hangzhou, Zhejiang, 310000
About this study
Official title: The Study of N-terminal Pro-brain Natriuretic Peptide Combined With High-sensitivity Troponin T in Evaluating the Prognosis of Sepsis
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.
Read the 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.
- Conditions
- Sepsis
- Keywords
- N-terminal pro-brain natriuretic peptide, High-sensitivity troponin T
- Medical subject headings
- Sepsis
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 2016.06.01-----2021.03.30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2021
- Study start26 May 2021
- Primary completion2 Jun 2021
- Study completion9 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- yang xufeng, MS, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04963699
- Sponsor's protocol ID
- 2021-0317
- Status last verified
- Jun 2016
- First submitted
- 9 Jun 2021
- Last updated
- 15 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of N-terminal Pro-brain Natriuretic Peptide Combined With High-sensitivity Troponin T in Evaluating the Prognosis of Sepsis
- ClinicalTrials.gov ID
- NCT04963699
- Acronym / sponsor ID
- 2021-0317
- Conditions
- Sepsis
- Keywords
- N-terminal pro-brain natriuretic peptide, High-sensitivity troponin T
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 26 May 2021 (actual)
- Primary completion
- 2 Jun 2021 (actual)
- Study completion
- 9 Jun 2021 (actual)
- First posted
- 15 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 16 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with sepsis who were diagnosed and treated in our hospital from June 2016 to March 2021
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
NT-proBNP
Time frame: 2016.06.01-----2021.03.30
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.
hs-cTnT
Time frame: 2016.06.01-----2021.03.30
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.
APACHEⅡ score
Time frame: 2016.06.01-----2021.03.30
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
yang xufeng, MS principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NT-proBNP (time frame: 2016.06.01-----2021.03.30). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2021.