Proadrenomedullin and Microcirculation in Monitoring Organ Dysfunction in Patient With Infection: Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Assessment of Microvascular Flow Index (MFI)
研究概览
简要总结
This study evaluates the association between plasmatic levels of Mid Regional Proadrenomedullin (MR-proADM) and the sublingual microcirculation in critical care patients admitted with infection, sepsis or septic shock.
详细描述
MR-proADM (Mid Region proAdrenomedullin) is a fragment of 48 amino-acids of ADM (Adrenomedullin), a protein belonging to the super-family of calcitonin-related peptides. MR-proADM is released in a 1:1 ratio with its native protein ADM. Blood levels of ADM are high in several conditions including infection, sepsis of septic shock. MR-proADM seems to be a promising marker for early diagnosis, prognosis and mortality in sepsis and it is also related to sepsis-induced organ failure.
The microcirculatory and endothelial damages represent two corner stones of the sepsis pathophysiology. They involved the loss of functional capillaries density and the loss of red blood cells deformability, the endothelial cell disfunction induced by sepsis, the induction of the apoptosis and necrosis, the alteration in the capillary permeability due to the loss of vasomotor tone and control. Moreover sepsis is characterised by the increased levels of adhesion molecules and the consequent interaction between neutrophils and endothelium, the fibrin deposition and the activation of the coagulation.
The aim of the study is to evaluate the correlation between the alteration in microcirculation and the levels of MR-proADM.
MFI (Microvascular Flow Index) is a qualitative measurement of microcirculation and the microcirculatory alterations during sepsis are crucial in the pathophysiology of this syndrome. It is related to prognosis and mortality in patient with sepsis in ICU (Intensive Care Unit)
Studying the relations between MFI and MR-proADM in the first five days of ICU stay could represent a good way to connect the pathophysiological background to a laboratory marker for an early diagnosis and for a measure of prognosis in patient with infections.
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
- •Suspected Infection, Infection, Sepsis or Septic Shock in patient admitted in ICU from no more than 24 hours and which have previously monitored blood pressure and have a central venous catheter in place.
排除标准
- •Age < 18 yo
- •Length of stay in ICU > 24 hours;
- •Length of stay in other hospital unit, ward or surgery > 48 hours;
- •Refusal of informed consent;
- •Conditions that do not allow the possibility of getting a monitoring of sublingual microcirculation (maxillofacial trauma, serious inability to jaw, copious blood loss or secretions from the mouth)
结局指标
主要结局
Assessment of Microvascular Flow Index (MFI)
时间窗: Five days
Correlation between plasmatic value of MR-proADM and variation in Microvascular Flow Index (MFI) in patients admitted in ICU with suspected infection. MFI is detected in vivo by Incident Dark Field (IDF) Imaging at sublingual microcirculation. It represents the quality of blood flow at microcirculatory level.
Assessment of the concentration of Mid Regional Proadrenomedullin (MR-proADM)
时间窗: Five days
Correlation between plasmatic value of MR-proADM and variation in Microvascular Flow Index (MFI) in patients admitted in ICU with suspected infection. Mid Regional Proadrenomedullin (MR-proADM, unity of measurement nmol/L) is measured through a specify immunoenzymatic assay. MR-proADM is a diagnostic and prognostic marker of infection and sepsis.
次要结局
- Cut-off for Microvascular Flow Index (MFI) based on Mid Regional Proadrenomedullin (MR-proADM) levels(Five days)
- Assessment of new organ failure(Five days)
- Assessment of patient's mortality(Five days)
- Assessment of Procalcitonine (PCT)(Five days)
- Assessment of other microcirculatory parameters in patient with sepsis or septic shock.(Five days)
- Mid Regional Proadrenomedullin (MR-proADM) in patient with difference infectious condition.(Five days)
- Correlation between Mid Regional Proadrenomedullin (MR-proADM) and glycocalix and endothelial damage.(Five days)
研究者
Abele Donati, MD
Clinical Professor
Università Politecnica delle Marche