Sepsis Cardiac InsufficiencyNCT06655389
Correlation Between PLA Levels and Disease Severity in Patients With Sepsis Cardiac Insufficiency
An observational study of Sepsis Cardiac Insufficiency, run by Dongzhimen Hospital, Beijing at 1 site in China.
Trial summary
Sepsis cardiac insufficiency is characterized by high morbidity and mortality. Studies have shown an association between elevated PLA levels in patients with sepsis and clinical outcomes of cardiac dysfunction. Read more about this study
- Who is it for?
- Ages 50 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Sepsis Cardiac Insufficiency
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2024to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 50 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Comparison of patients with sepsis cardiac insufficiency with healthy people
Who may be able to join
- Sepsis cardiac insufficiency group
- From April 2024 to December 2026, in the first ICU area of Dongzhimen Hospital, Beijing University of Chinese Medicine, Hospitalized patients in Zone II;
- consistent with the diagnosis of sepsis cardiac insufficiency;
- Age ≥ 50 and ≤ 90 years old;
- SOFA score≥ 2 points;
- Within 24 hours of the diagnosis of cardiac insufficiency in sepsis;
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- The patient or his/her family members sign the informed consent form. Healthy subjects
- <!-- -->
- Aged ≥ 50 and ≤ 90 years old, permanent residents of Beijing community;
- Good health (blood routine, liver and kidney function, blood lipids, blood coagulation, no obvious abnormalities, no diagnosis cardiac insufficiency, acute coronary syndrome, old myocardial infarction, or cardiomyopathy);
- There is no history of long-term use of drugs that affect platelet function and coagulation function, and those who are willing to cooperate with the test Crowd;
- The subject himself signed the informed consent form.
Who cannot join
- 1) Diagnosed with acute coronary syndrome, old myocardial infarction, and coronary heart disease revascularization of patients; (2) Cardiac insufficiency due to cardiomyopathy, such as hypertrophic cardiomyopathy, dilated cardiomyopathy, myocardial amyloidosis, diabetic cardiomyopathy, hypothyroidic cardiomyopathy, etc.; (3) Due to heart knots Cardiac insufficiency caused by structural abnormalities, arrhythmias, cor pulmonale, nephroheart syndrome, etc.; (4) Impact Survival of severe primary diseases, including: uncontrolled malignant tumors that have metastasized in multiple places and cannot be resected, and blood disease, novel coronavirus infection and HIV, etc.; (5) Liver and kidney dysfunction with a single SOFA score of ≥3 points in liver or kidney handicappers; (6) Those who have been continuously using immunosuppressants or organ transplantation in the past 6 months; (7) 7 consecutive days prior to enrollment Those who have used corticosteroids, converted to methylprednisolone dose≥ 20mg/day; (8) Pregnant and lactating women; (9) Take or Injection of drugs that affect platelet function and coagulation function; (10) Those who have participated in other clinical trials within 30 days.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
DongzhimenH，Beijing
Beijing, Beijing Municipality, 100700
Yao Sheng Xiu, 15600089226, a2w029@bucm.edu.cn
About this study
Sepsis cardiac insufficiency is characterized by high morbidity and mortality. Studies have shown an association between elevated PLA levels in patients with sepsis and clinical outcomes of cardiac dysfunction. This study will explore the correlation between circulating PLA levels and organ dysfunction and disease severity in SIMD patients in the form of a cross-sectional study.
Read the detailed description
Sepsis cardiac insufficiency is an unsolved problem in the field of severe disease, which is characterized by high morbidity and high mortality. Several studies have found that infectious factors activate platelets and inflammatory cells, damage the vascular endothelium, and cause leukocytes to interact with platelets to form platelet-leukocyte aggregates, and elevated PLA levels in patients with sepsis are associated with the clinical outcome of cardiac dysfunction. The literature studies have shown that the serum PLA level in sepsis patients is significantly increased, and the PLA level is positively correlated with the severity of cardiac dysfunction in sepsis patients, and the formation of PLA is regulated by the binding of CD62P on the surface of activated platelets and PSGL-1 on the surface of leukocytes. This study will explore the correlation between circulating PLA levels and organ dysfunction and disease severity in patients with SIMD in the form of a cross-sectional study, in order to provide a new potential direction for the evaluation and treatment of SIMD.
- Conditions
- Sepsis Cardiac Insufficiency
- Keywords
- Sepsis cardiac insufficiency, PLA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Sepsis cardiac insufficiency group | Cardiac dysfunction or hemodynamic abnormalities in patients with sepsis, combined with abnormal cardiac ultrasound findings, markers of myocardial injury, and/or markers of cardiac function 1. From April 2024 to December 2026, in the first ICU area of Dongzhimen Hospital, Beijing University of Chinese Medicine,Hospitalized patients in Zone II; 2. consistent with the diagnosis of sepsis cardiac insufficiency; 3. Age ≥ 50 and ≤ 90 years old; 4. SOFA score≥ 2 points; 5. Within 24 hours of the diagnosis of cardiac insufficiency in sepsis; 6. The patient or his/her family members sign the informed consent form. | |
| Healthy subjects | 1. Aged ≥ 50 and ≤ 90 years old, permanent residents of Beijing community; 2. Good health (blood routine, liver and kidney function, blood lipids, blood coagulation, no obvious abnormalities, no diagnosis cardiac insufficiency, acute coronary syndrome, old myocardial infarction, or cardiomyopathy); 3. There is no history of long-term use of drugs that affect platelet function and coagulation function, and those who are willing to cooperate with the test Crowd; 4. The subject himself signed the informed consent form. |
What is being measured
The primary outcome is the main question the study is designed to answer.
PLA
Platelet-leukocyte aggregate levels
Measured: At the time of admission
Secondary outcomes (4)
Echocardiography
Echocardiography assesses cardiac function
Measured: At the time of admission
APACHEII
Acute Physiology and Chronic Health Evaluation
Measured: At the time of admission
SOPA
Sequential organ failure score
Measured: At the time of admission
BNP
Brain natriuretic peptide
Measured: At the time of admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start1 May 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sepsis Cardiac InsufficiencyStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dongzhimen Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiu Shengyao, Dongzhimen Hospital, Beijing
- Investigators
- Nan Guo, Chief physician, Principal investigator, DongzhimenH，Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06655389
- Sponsor's protocol ID
- Nan Guo（Dongzhimen）
- Status last verified
- Oct 2024
- First submitted
- 22 Oct 2024
- Last updated
- 23 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between PLA Levels and Disease Severity in Patients With Sepsis Cardiac Insufficiency
- ClinicalTrials.gov ID
- NCT06655389
- Acronym / sponsor ID
- Nan Guo（Dongzhimen）
- Conditions
- Sepsis Cardiac Insufficiency
- Keywords
- Sepsis cardiac insufficiency, PLA
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Dongzhimen Hospital, BeijingUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 23 Oct 2024 (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.
Sepsis cardiac insufficiency is characterized by high morbidity and mortality. Studies have shown an association between elevated PLA levels in patients with sepsis and clinical outcomes of cardiac dysfunction. This study will explore the correlation between circulating PLA levels and organ dysfunction and disease severity in SIMD patients in the form of a cross-sectional study.
Detailed description
Sepsis cardiac insufficiency is an unsolved problem in the field of severe disease, which is characterized by high morbidity and high mortality. Several studies have found that infectious factors activate platelets and inflammatory cells, damage the vascular endothelium, and cause leukocytes to interact with platelets to form platelet-leukocyte aggregates, and elevated PLA levels in patients with sepsis are associated with the clinical outcome of cardiac dysfunction. The literature studies have shown that the serum PLA level in sepsis patients is significantly increased, and the PLA level is positively correlated with the severity of cardiac dysfunction in sepsis patients, and the formation of PLA is regulated by the binding of CD62P on the surface of activated platelets and PSGL-1 on the surface of leukocytes. This study will explore the correlation between circulating PLA levels and organ dysfunction and disease severity in patients with SIMD in the form of a cross-sectional study, in order to provide a new potential direction for the evaluation and treatment of SIMD.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sepsis cardiac insufficiency group | – | –Cardiac dysfunction or hemodynamic abnormalities in patients with sepsis, combined with abnormal cardiac ultrasound findings, markers of myocardial injury, and/or markers of cardiac function 1. From April 2024 to December 2026, in the first ICU area of Dongzhimen Hospital, Beijing University of Chinese Medicine,Hospitalized patients in Zone II; 2. consistent with the diagnosis of sepsis cardiac insufficiency; 3. Age ≥ 50 and ≤ 90 years old; 4. SOFA score≥ 2 points; 5. Within 24 hours of the diagnosis of cardiac insufficiency in sepsis; 6. The patient or his/her family members sign the informed consent form. |
| Healthy subjects | – | –1. Aged ≥ 50 and ≤ 90 years old, permanent residents of Beijing community; 2. Good health (blood routine, liver and kidney function, blood lipids, blood coagulation, no obvious abnormalities, no diagnosis cardiac insufficiency, acute coronary syndrome, old myocardial infarction, or cardiomyopathy); 3. There is no history of long-term use of drugs that affect platelet function and coagulation function, and those who are willing to cooperate with the test Crowd; 4. The subject himself signed the informed consent form. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Comparison of patients with sepsis cardiac insufficiency with healthy people
Key inclusion criteria (12 listed)
- Sepsis cardiac insufficiency group
- <!-- -->
Key exclusion criteria (1 listed)
- 1) Diagnosed with acute coronary syndrome, old myocardial infarction, and coronary heart disease revascularization of patients; (2) Cardiac insufficiency due to cardiomyopathy, such as hypertrophic cardiomyopathy, dilated cardiomyopathy, myocardial amyloidosis, diabetic cardiomyopathy, hypothyroidic cardiomyopathy, etc.; (3) Due to heart knots Cardiac insufficiency caused by structural abnormalities, arrhythmias, cor pulmonale, nephroheart syndrome, etc.; (4) Impact Survival of severe primary diseases, including: uncontrolled malignant tumors that have metastasized in multiple places and cannot be resected, and blood disease, novel coronavirus infection and HIV, etc.; (5) Liver and kidney dysfunction with a single SOFA score of ≥3 points in liver or kidney handicappers; (6) Those who have been continuously using immunosuppressants or organ transplantation in the past 6 months; (7) 7 consecutive days prior to enrollment Those who have used corticosteroids, converted to methylprednisolone dose≥ 20mg/day; (8) Pregnant and lactating women; (9) Take or Injection of drugs that affect platelet function and coagulation function; (10) Those who have participated in other clinical trials within 30 days.
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
PLA
Time frame: At the time of admission
Platelet-leukocyte aggregate levels
4 secondary outcomes
Echocardiography
Time frame: At the time of admission
APACHEII
Time frame: At the time of admission
SOPA
Time frame: At the time of admission
BNP
Time frame: At the time of admission
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2024.
- Individual participant dataSharing planned: No
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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.
Nan Guo, Chief physician principal investigator
DongzhimenH，Beijing
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 Cardiac Insufficiency, run by Dongzhimen Hospital, Beijing 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 12 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: looking for participants now, as of the sponsor's last update on 23 Oct 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yao Sheng Xiu (86-15600089226, a2w029@bucm.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PLA (time frame: At the time of admission). 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 23 Oct 2024.