Correlation Between PLA Levels and Disease Severity in Patients With Sepsis Cardiac Insufficiency

NCT06655389 | Recruiting DMC

• 1 other identifier: Nan Guo（Dongzhimen）
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Sepsis Cardiac Insufficiency

Keywords

Sepsis cardiac insufficiency; PLA

Outcome Measures

Primary Outcomes (1)

• PLA

  Platelet-leukocyte aggregate levels

  At the time of admission

Secondary Outcomes (4)

• Echocardiography

  At the time of admission

• APACHEII

  At the time of admission

• SOPA

  At the time of admission

• BNP

  At the time of admission

Study Arms (2)

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.

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Comparison of patients with sepsis cardiac insufficiency with healthy people

You may qualify if:

• 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;
• The patient or his/her family members sign the informed consent form. Healthy subjects
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• 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.

You may not qualify if:

• \) 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.

Sponsors & Collaborators

• Dongzhimen Hospital, Beijing: lead

Study Sites (1)

DongzhimenH，Beijing

Beijing, Beijing Municipality, 100700, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood

Study Officials

• Nan Guo, Chief physician

  DongzhimenH，Beijing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yao Sheng Xiu

CONTACT

86-15600089226; a2w029@bucm.edu.cn

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: physician

Study Record Dates

• First Submitted: October 22, 2024
• First Posted: October 23, 2024
• Study Start: May 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 23, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)