Renin Levels as Prognostic Indicators of Septic Shock Severity and Outcome: Prospective Cohort Study (SOS Trial)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Correlation between blood renin concentration and norepinephrine dosage
研究概览
简要总结
The Surviving Sepsis Campaign (SSC) of 2021 characterizes sepsis as a life-threatening organ dysfunction caused by a dysregulated host response to infection, with a mortality rate of over 30%, which increases to 40% or more in the case of septic shock. Although concept of sepsis has improved, significant gaps remain in assessing its clinical severity and predicting patient outcomes.
Recognized markers of the severity of septic shock are procalcitonin (PCT), presepsin, and, to a certain extent, lactate. Elevated lactate levels result from a shift to anaerobic glycolysis and indicate inadequate oxygen delivery to tissues. Despite the importance of procalcitonin in the course of sepsis, it has proven to be a suboptimal diagnostic biomarker for the development of sepsis, with sensitivity and specificity below 80%. As a result, the use of procalcitonin in addition to clinical assessment to determine the indications for initiating antibiotic therapy is not recommended. Meanwhile, presepsin, although a potential biomarker for the early diagnosis of sepsis, also has only moderate accuracy according to current data and cannot be used as the only test for the diagnosis of sepsis.
Renin is a crucial enzyme in the renin-angiotensin-aldosterone system (RAAS), which plays an important role in the regulation of blood pressure, tissue perfusion, and the balance of water and electrolytes. Thus, renin may be the sensitive biomarker with good prognostic qualities in the context of sepsis and septic shock. Preliminary studies have indicated that elevated renin levels may act as an indicator of patient severity, and could also be used as a marker for the development of septic shock and mortality prognosis.
This study aims to address these gaps by investigating the role of renin as a biomarker for the severity of sepsis and septic shock, focusing on its potential for more accurate prediction of clinical 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
- •Age ≥ 18 years
- •Hospitalization in the intensive care unit
- •Confirmed diagnosis of Sepsis within 24 hours
- •Signed informed consent or a decision by the medical council to include the patient in the study
排除标准
- •Any surgical intervention on the kidneys and/or adrenal glands performed within 28 days prior to the patient's inclusion in the study
- •Patients previously included in this study
结局指标
主要结局
Correlation between blood renin concentration and norepinephrine dosage
时间窗: Through study completion, an average of 2 years
A correlation analysis with the calculation of the correlation strength. The degree of correlation ranges from 0 to 1. The closer the correlation coefficient is to one, the stronger the correlation.
次要结局
- Correlation between blood renin concentration and blood procalcitonin concentration(Through study completion, an average of 2 years)
- Correlation between blood renin concentration and peripheral blood flow(Through study completion, an average of 2 years)
- Correlation between blood renin concentration and SOFA score(Through study completion, an average of 2 years)
- Correlation between blood renin concentration and renal replacement therapy free days(Through study completion, an average of 2 years)
- Correlation between blood renin concentration and blood lactate concentration(Through study completion, an average of 2 years)
- 28-days mortality(28 days)
- Frequency of Major Adverse Kidney Events (MAKE)(28 days)
研究者
Valery Likhvantsev
MD, PhD
Federal Research and Clinical Centre of Intensive Care Medicine and Rehabilitology