Multiscale Approach to Describe the Evolution of Molecular Biomarkers in Acute Heart Failure Induced by Shock
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 3
- 主要终点
- Progression/occurrence of acute heart failure and changes in omics markers in acute phase of shock
研究概览
简要总结
The relationship between shock, ischemia and reperfusion (I/R) injury, hemodynamic instability, systemic inflammatory response syndrome and multiorgan failure has been extensively investigated, but there is no consensus on the trigger mechanisms of tissue injury at the molecular level.
Current therapies are targeted to reduce symptoms of shock and multiorgan damage but they are unable to act at the "beginning of the cascade", because of the lack of a model explaining the molecular basis of shock induced tissue injury and ensuing organ damage.
The present observational study is aimed at identifying the molecular triggers of acute heart failure (HF) induced by shock and to identify inflammatory mediators and markers that are activated in shock, with a particular emphasis on the role of uncontrolled proteolytic activity.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For patients in septic shock, Severity: SOFA score > 5
- •For patients in cardiogenic shock, Severity: SOFA score > 5
- •First blood sample available within 16 hours from admission to the ICU.
- •Only community medical acquired septic shock. We include patients with shock symptoms and shock diagnosis occurring within the first 48 hours from hospital admission
- •Informed Consent available
排除标准
- •Risk of rapidly fatal illness and death within 24 hours
- •Patients already enrolled in other interventional studies
- •N > 4 units of red blood cells transfused
- •Patients treated with plasma or whole blood
- •Active hematological malignancy
- •Metastatic cancer
- •Immunodepression, including transplant patients: HIV+, constitutive immune system deficiency, immunosuppressive therapy, systemic corticosteroids (aerosols allowed)
- •Patients with pre-existing end stage renal disease needing renal replacement therapy (RRT). The introduction of continuous veno-venous hemofiltration (CVVH), from the day of admission onward is allowed.
- •Cardiac surgery patients
- •Cirrhosis Child C
结局指标
主要结局
Progression/occurrence of acute heart failure and changes in omics markers in acute phase of shock
时间窗: within 48 hr after admission in ICU (acute phase of shock)
The clinical endpoint will be Acute Heart Failure (AHF), assessed by a pool of measures/estimates of cardiac function and filling pressures, based on cardiac output monitoring, inotropic drugs requirements, left and right ventricles assessment using echocardiography. The molecular biomarkers changes will be evaluated by means of proteomics, transcriptomics and metabolomics analysis of blood samples collected at the ICU admission and within 48hr after admission.
次要结局
- Progression/Occurence of Acute Heart Failure and changes in omics markers in survivors(within 7 days after admission in ICU (patient stabilization))