Cuantificación de la Disfunción Inmunitaria Inducida Por la Enfermedad Crítica Mediante el Estudio de un Panel de Genes y Moléculas Implicadas en la Sinapsis Inmunológica y su Utilidad Pronóstica
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Proportion of patients with a functional immunosuppression signature
研究概览
简要总结
Critical illnesses represent a significant physiological assault that triggers changes in the patient's immune system, resulting in an immunopotentiating response (systemic inflammatory response syndrome, SIRS) and an immunosuppressive response (compensatory anti-inflammatory response syndrome, CARS). The balance between SIRS and CARS is essential for the patient to return to a state of immune homeostasis and accelerate the healing process. However, when CARS is disproportionately intense, it leads to a state of immunoparalysis, which predisposes the patient to vulnerability to opportunistic infections, associated with a peak in late mortality. The majority of patients admitted to the ICU are considered immunocompetent. However, the investigators suspect that a significant proportion of them exhibit predominance of CARS and a state of functional immunosuppression. There is currently no diagnostic test to determine whether a patient is functionally immunocompetent at a specific point in time.
The goal of this observational study is to learn about the immune system dysfunction occurring in critical illness. The main questions it aims to answer are:
- What is the prevalence of immune system dysfunction in critical illness?
- Does immune system dysfunction affect multiple organ failure trajectory and mortality in critical illness?
- Is immune system dysfunction related to an increased risk of opportunistic hospital-acquired infections in critical illness?
- Is immune system dysfunction related to age, fragility, nutritional status or previous comorbidities in critical illness?
To answer these questions, the investigators will prospectively study a population of critically ill patients, defined by the presence of organ failure. The investigators will analyse a panel of genes and molecules involved in immunological synapse, using peripheral blood samples at different moments of the evolution of critical illness. Based on the analysis, the investigators will classify the patients' functional immune status and correlate it with the outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Failure of one or more organs, assessed by a Sequential Organ Failure Assessment Score (SOFA) ≥4 within the first 24 hours of admission to the Intensive Care Unit (ICU). At least one of the physiological systems involved must be in the category of organ failure and, therefore, score ≥
- •Informed consent to participate in the study.
- •Age equal to or greater than 18 years.
排除标准
- •Pharmacological immunosuppression within the 3 months prior to the current admission date, including treatment with corticosteroids, immunosuppressive drugs (conventional or biological), or chemotherapy.
- •Immunodeficiency.
- •Age under 18 years.
- •Absence of consent to participate in the study.
结局指标
主要结局
Proportion of patients with a functional immunosuppression signature
时间窗: 5 days
Number of patients with organ failure exhibiting an early transcriptomic signature denoting depression of the immunological synapse.
Mortality (28-day)
时间窗: 28 days
Number of non-surviving patients in the groups with and without an early functional immunosuppression signature.
Hospital-Acquired Infection (28-day)
时间窗: 28 days
Number of patients developing hospital-acquired infections in the groups with and without an early functional immunosuppression signature.
Organ Failure Resolution (28-day)
时间窗: 28 days
Number of patients with organ failure resolution in the groups with and without an early functional immunosuppression signature.
次要结局
- Hospital-Acquired Infection (90-day)(90 days)
- Mortality (90-day)(90 days)
- Proportion of patients with early cardiac dysfunction(5 days)
- Duration of hospitalization in the ICU(90 days)
- Proportion of patients requiring organ support(90 days)
- Proportion of patients with Herpesviridae reactivation(90 days)
- Proportion of patients with ICU-related complications(90 days)
- Proportion of patients with post-intensive care syndrome(90 days)
研究者
David Pérez Torres
Principal Investigator
University of Valladolid