A Prospective Observational Study on Assessment of the Soluble Urokinase Plasminogen Activator Receptor in Adult Patients Undergoing Major Non-cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Number of participants admitted to Intensive Care Unit
研究概览
简要总结
In critically ill patients, the soluble urokinase plasminogen activator receptor (suPAR) level is significantly increased. suPAR is an independent prognostic marker, and the change over time correlates with organ dysfunction. suPAR is elevated and has a prognostic value in patients with systemic inflammatory response syndrome, sepsis/septic shock, burn injuries, and traumatic brain injuries. SPARSE is a prospective observational study aiming to investigate if suPAR measured preoperatively and immediately after surgery can predict the risk of future complications and post-operative mortality in adults following major non-cardiac surgery. Participants will undergo sampling of peripheral venous blood, immediately after arrival to the Operating Room and at the Post-Anesthesia Care Unit, and plasma suPAR levels will be determined. In addition to routine hemodynamic data, sublingual microvascular flow will be measured using noninvasive technology. The primary endpoint will be the presence of complications and/or admission to ICU and/or mortality within the first 60 postoperative days. Target enrollment will be 100 patients.
详细描述
BACKGROUND
Soluble urokinase plasminogen activator receptor
The biomarker soluble urokinase plasminogen activator receptor (suPAR) is the soluble form of the cell membrane-bound protein urokinase plasminogen activator receptor (uPAR), which is expressed mainly on immune cells, endothelial cells, and smooth muscle cells. uPAR is released during inflammation or immune activation, and therefore the suPAR level reflects the extent of immune activation in the individual. All human beings have a baseline level of suPAR that is individually determined and increases with age. Studies have shown that the suPAR level is associated with morbidity and mortality in a number of acute and chronic diseases and in the general population. The suPAR level is elevated across diseases, and not solely associated with one specific disease. Therefore, suPAR is applicable as a prognostic marker and not as a diagnostic marker. This characteristic may be utilized for risk stratification in unselected patients.
In critically ill patients, the suPAR level is significantly increased. suPAR is an independent prognostic marker, and the change over time correlates with organ dysfunction. suPAR is elevated and has a prognostic value in patients with: SIRS (systemic inflammatory response syndrome), sepsis/septic shock, burn injuries, and traumatic brain injuries. The suPAR level reflects the body's immune response to infections, and the level increases with the severity of the infection. In patients with organ dysfunction, the suPAR value is often a two-digit value. In particular hepatic and renal dysfunction affects the suPAR level.
suPAR in surgery
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
- •All operative approaches
- •Age ≥ 18 years
- •American Society of Anesthesiologists' (ASA) physical status I to IV
排除标准
- •Age <18 years
- •Any infection within the previous 4 weeks
- •Severe liver disease
- •Renal replacement therapy pre-operatively
- •Previously received transplant
- •Allergies
- •Inflammatory disorders
- •Immune system disorders
- •Connective tissue disease
- •Administration of opioids during the past week
- •Obesity (BMI ≥ 30 kg m-2)
- •Mental disability
- •Severe psychiatric disease
- •Alcohol or other abuse,
- •Legal incapacity or limited legal capacity
- •Subjects within the exclusion period of another study
结局指标
主要结局
Number of participants admitted to Intensive Care Unit
时间窗: Within the first 60 postoperative days
Number of participants admitted to Intensive Care Unit
Number of participants with postoperative complications
时间窗: Within the first 90 postoperative days
Number of participants with postoperative complications
Number of deaths
时间窗: Within the first 60 postoperative days
Number of deaths
次要结局
- Number of participants with acute new arrhythmia during sugery(During surgery)
- Survival(At 30 days, at 90 days, and at 1 year)
- Number of reintubations(At 30 days)
- Number of participants with intraoperative complications(During surgery)
- Number of participants with need for unplanned vasoactive drugs during surgery(During surgery)
研究者
Athanasios Chalkias, MD, PhD
Asst. Professor of Anesthesiology
University of Thessaly