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

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.

Study Overview

• Status: Recruiting
• Conditions: Sepsis Cardiac Insufficiency

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 Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Yao Sheng Xiu; Phone Number: 86-15600089226; Email: a2w029@bucm.edu.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100700
      • Recruiting
      • DongzhimenH，Beijing
      • Contact: Yao Sheng Xiu; Phone Number: 15600089226; Email: a2w029@bucm.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Comparison of patients with sepsis cardiac insufficiency with healthy people

Description

Inclusion Criteria:

• Sepsis cardiac insufficiency group

  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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PLA	Platelet-leukocyte aggregate levels	At the time of admission

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Echocardiography	Echocardiography assesses cardiac function	At the time of admission
APACHEII	Acute Physiology and Chronic Health Evaluation	At the time of admission
SOPA	Sequential organ failure score	At the time of admission
BNP	Brain natriuretic peptide	At the time of admission

Collaborators and Investigators

• Sponsor: Dongzhimen Hospital, Beijing
• Investigators: Principal Investigator: Nan Guo, Chief physician, DongzhimenH，Beijing

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: October 22, 2024
• First Submitted That Met QC Criteria: October 22, 2024
• First Posted (Actual): October 23, 2024

Study Record Updates

• Last Update Posted (Actual): October 23, 2024
• Last Update Submitted That Met QC Criteria: October 22, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: PLA; Sepsis cardiac insufficiency
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Heart Failure; Sepsis; Toxemia
• Other Study ID Numbers: Nan Guo（Dongzhimen）

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No