Hemodynamic Evaluation Using Microcirculation for Early Treatment of Septic Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 556
- 试验地点
- 12
- 主要终点
- Number and proportion of patients presenting clinical deterioration during emergency care
研究概览
简要总结
Despite early treatment, the deterioration and mortality of sepsis patients remains high. A possible explanation could be persistent tissue hypoperfusion, or undetected in the early phase despite the normalization of macro-hemodynamic parameters. This interventional study evaluates the impact of measuring microcirculation parameters by nurses on patient prognosis through early initiation of vascular filling.
详细描述
Sepsis and its most serious form, septic shock, are a public health problem. Sepsis is defined by the presence of organ failure, including acute circulatory failure, which combines hypovolemia, vasoplegia and cardiac dysfunction. Vascular filling is therefore a pillar of the management of septic patients to correct hypovolemia and improve perfusion and tissue oxygenation. Following numerous studies, the evaluation of peripheral microcirculation is becoming a clinical "trigger" making it possible to identify patients at risk, particularly in emergency department. In a meta-analysis, it has been showed that alterations in microcirculatory perfusion predict deterioration and mortality during severe infections. Currently, no interventional study has evaluated the impact of measuring microcirculatory perfusion (peripheral perfusion index and marbling) by nurses on patient prognosis through early initiation of vascular filling.
In this study, patients will be assessed hemodynamically using peripheral perfusion index and/or presence of mottling. If peripheral perfusion index > 3s and/or presence of marbling a first vascular filling test of 500 cc over 30 minutes will be started after a medical control.
Patient will be followed up 7 days to determine outcome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Admitted to the Emergency Department for suspected Sepsis for less than 6 hours according to international Sepsis-3 definitions (high probability of infection defined by a fever greater than or equal tol to 38.3°C with a suspected infectious source + Score NEWS 2 greater than or equal to 2)
- •Affiliated to a social security system
- •Having agreed to participate in this study
排除标准
- •Patient with arterial hypotension (SBP ≤ 100 mmHg) on admission
- •Patient having already received a 500mL filling test over 30 minutes
- •Patients moribund according to the investigator
- •Pregnancy or breastfeeding
- •Patient under guardianship, curatorship or safeguard of justice
结局指标
主要结局
Number and proportion of patients presenting clinical deterioration during emergency care
时间窗: between time of inclusion and 24 hours after
Clinical deterioration is defined by (composite criterion): 1. Arterial hypotension defined by systolic blood pressure (SBP) ≤ 100 mmHg 2. Implementation of treatment for organ support: * Vasopressor or inotrope * Invasive ventilation 3. Abnormal lactate concentration (\> 2mmol/L), without improvement (absence of decay) 4. Patient admitted in intensive care unit 5. Death
次要结局
- Number and proportion of patients who received bundles (i) one hour and (ii) 3 hours of admission to the Emergency Department(from admission to the Emergency Department to 3 hours after)
- Difference in SOFA score (≥ 2 points) between Hours 0 and Hours 24 (24h±6h)(between Hours 0 and Hours 24)
- Number and proportion of deaths on Day 7(from enrollement to the end of the patient participation at Day 7)
- Number and proportion of patients with hydrostatic pulmonary oedema (cardiogenic or volume overload) or receiving diuretic treatment during emergency care(from enrollment to the end of the subject participation at day 7)
- The correlation of the peripheral perfusion index measurement (pathological : yes/no) between the nurse and the emergency physician(hour 0)
- Number and proportion of patients sent home, conventional hospitalization or intensive care(from enrollment to the end of the subject participation at day 7)