Impact of an Echographic Algorithm on Hemodynamic Optimization in the First 4 Days of Septic Shock Management: a Multicentric, Randomized, Controlled, Open Label Pilot-study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Volume of vascular filling during the first 4 days
研究概览
简要总结
Fluid management is one of the key issues in the initial management of septic shock (SS). Fluid overload and hypovolemia have been associated with increased mortality in several trials. Transthoracic echocardiography (TTE) and lung ultrasound are recommended for haemodynamic assessment in critically ill patients. However, the benefit of hemodynamic optimisation using echography has not been yet evaluated. The purpose of this multicenter, controlled, randomized trial is to assess the impact of an echocardiographic algorithm of hemodynamic optimization on fluid management in septic patients during the first 4 days of therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •All eligible patients will have a cardiac echocardiogram prior to inclusion for the sole purpose of eliminating special situations that are part of the non-inclusion criteria listed below.
- •Inclusion Criteria
- •Patient in an intensive care unit who develops septic shock on admission or during hospitalization, as defined by SEPSIS-3 criteria.
- •Patient or trusted person / legal representative / family member / curator / guardian who has given free and informed consent and has signed the consent form or patient included in an emergency situation.
- •Patient affiliated or beneficiary of a health insurance plan.
- •Patient at least (≥) 18 years of age.
排除标准
- •Refusal of consent.
- •Patient under court protection or guardianship.
- •Moribund patient with a life expectancy of less than 48 hours.
- •Non-echogenic patient.
- •Cardiac tamponade.
- •Infective endocarditis.
- •Intracavitary thrombus.
- •Dilated cardiomyopathy with LVEF (Left Ventricular Ejection Fraction<40%.
- •Parturient or nursing patient.
研究组 & 干预措施
Interventional Strategy: STOPFLUID Algorithm
Fluid management is optimised using the specific echographic hemodynamic algorithm ('STOPFLUID') of this study described during the first 4 days of septic shock. Fluid bolus will not be administered in case of increased left ventricle filling pressures; fluid challenge will be performed based on dynamic indices and fluid depletion will be considered on the basis of Lung UltraSound (LUS) assessment.
干预措施: Echographic hemodynamic algorithm guiding fluid resuscitation (Other)
Standard Strategy
Fluid management will be handled according to standard care, without using transthoracic echocardiography (TTE) during the first 4 days of septic shock management. Haemodynamic monitoring including pulmonary artery catheter, transpulmonary thermodilution, or any other device will be left at the physician's discretion. TTE will be allowed in the standard group only for excluding cardiac tamponade in case of clinical suspicion (one or more of the following signs: jugular distension, pulsus paradoxus)
结局指标
主要结局
Volume of vascular filling during the first 4 days
时间窗: Day 4
This takes into account the cumulative volume of vascular filling administered to improve cardiac output during the 4 first days, measured in Liter (L)
次要结局
- Analysis of the primary endpoint related to severe renal dysfunction(Day 4)
- .Analysis of the primary endpoint related to ARDS ([acute respiratory distress syndrome, according to Berlin criteria)(Day 4)
- Analysis of the primary endpoint in relation with patient severity(Day 4)
- Mortality(Day 28)
- Number of days alive without failure at Day 28(Day 28)
- Therapeutic adjustments including bolus vascular filling, changes in vasopressor flow, and administration of diuretics(Day 4)
- Adverse effects(Day 28)
- Fluid balance in L(Day 4)
- Length of stay in ICU (ready for discharge)(Day 28)
- Time to normalization of lactatemia (<2 mmol/l)(Day 4)
- Length of stay in hospital(Day 28)