Exploring the Differential Immune Responses in Community-Acquired Sepsis through Plasma Mediators and Immune Cell Analysis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Association of plasma and immune cell mediators with 28 day mortality
研究概览
简要总结
Sepsis remains a major global health burden with high mortality and limited therapeutic options beyond supportive care. The current treatment approaches often fail to save sepsis patients, highlighting the urgent need to deepen our understanding of the immune system’s role in the disease. Advancing immune research could enable the development of novel, targeted therapies that potentially reduce healthcare costs, save and improve the quality of millions of lives. Today, supportive interventions including quick antibiotic delivery, efficient source control, and organ support are crucial to the therapy of sepsis. Despite their need, these tactics frequently fail to increase survival because they ignore immunological dysregulation, which is crucial to the development of sepsis. Identifying subgroups and various endotypes within patients with distinctive immune profiles will provide chances for focused treatment approaches.
This study aims to characterize the immune profiles of patients with community-acquired sepsis, to understand the temporal changes in immune response and identify distinct immunological patterns that may benefit from precision interventions. This is a prospective, observational study enrolling patients with community-acquired sepsis from a tertiary care hospital in South India. Peripheral blood samples will be collected from the critically ill patients with sepsis and sterile inflammation at three time points. Healthy individuals will also be recruited for the baseline establishment. Clinical and demographic data will be collected from all the recruited study subjects. Plasma cytokine and chemokine levels will be analyzed using Luminex multiplex assays to profile dynamic changes in immune parameters. Immune cell populations, including T cells, B cells, NK cells, and monocytes, will be quantified from isolated PBMCs using flow cytometry, with a focus on temporal variations and group-specific immune patterns. Identifying distinct immune signatures and temporal patterns in sepsis will enhance our understanding of disease heterogeneity and support the development of stratified immunomodulatory therapies.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)(—)
- 性别
- All
入选标准
- •Patient Group
- •Adult patients (age 18 and above) admitted to the ICUs with sepsis, shock and other inflammatory conditions like trauma, poisoning, pancreatitis.
- •SOFA score greater than 2 Healthy Controls
- •Healthy adults (18 years and above) not admitted to the hospital or those with well-controlled underlying conditions (hypertension, diabetes etc.)
- •Able and willing to provide the informed consent.
排除标准
- •Patient group
- •Age less than 18 years
- •Pregnant or breast-feeding women
- •Confirmed viral, fungal, parasitic, polymicrobial infections.
- •Patients with a withdrawal of care decision at time of inclusion
- •Patients whose anticipated duration of hospitalisation in ICU is estimated less than 48 hours.
- •Patient with restricted liberty or under legal protection
- •Expected lifespan less than 3 months due to pre-existing co-morbidities
- •Blood transfusion greater than 4 units in past week
- •Second admission to ICU or previous enrolment in study (within same hospital admission) Transfer from other hospital ICU Healthy Controls
- •Pregnant or breast-feeding
- •Infected with any infectious diseases
- •Hemophilia, severe coagulation disorders or impaired venous access
- •Prolonged antibiotic usage in the last 3 months
- •History of sepsis/septic shock in the last 6 months.
结局指标
主要结局
Association of plasma and immune cell mediators with 28 day mortality
时间窗: Three time points from ICU admission to 28 day follow up
次要结局
未报告次要终点
研究者
Dr Chiranjay Mukhopadhyay
Kasturba Medical College, Manipal
