Prospective, Randomized, Multicenter, Controlled Trial Assessing the Personalization of Mean Arterial Pressure in Adult Patients With Cardiogenic Shock
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 406
- 试验地点
- 11
- 主要终点
- The primary endpoint will be a composite of mortality, use of cardiac mechanical circulatory support, and severe renal failure.
研究概览
简要总结
Cardiogenic shock is a life-threatening condition characterized by inadequate cardiac output, leading to organ hypoperfusion and high mortality. Maintaining mean arterial pressure (MAP) is crucial, but standard targets may be insufficient due to venous congestion. Central venous pressure (CVP) can help assess effective perfusion pressure. This study investigates whether a personalized MAP target adjusted by CVP improves organ function and survival compared to standard MAP management.
详细描述
Cardiogenic shock is a severe and life-threatening condition. Its prognosis remains very poor with a high mortality rate (up to 50% in clinical series) despite recent therapeutic advances. Current recommendations suggest the use of inotropes and vasopressors to maintain tissue perfusion and prevent organ failure.
During cardiogenic shock, the mean arterial pressure (MAP) level is associated with survival. A post hoc analysis of a recent randomized trial found increased mortality among patients in cardiogenic shock whose average MAP was <70 mmHg during the first 36 hours after randomization, compared to patients with MAP ≥70 mmHg (58% vs. 29%, p<0.01). Another observational study found higher mortality among patients with a mean MAP <65 mmHg during the first 24 hours of shock compared to those with MAP ≥65 mmHg (57% vs. 28%, p<0.001). In this study, the incidence of renal failure was also inversely associated with MAP level. The optimal MAP target remains unknown during cardiogenic shock.
Due to the characteristic venous congestion, the effective perfusion pressure may be very low during cardiogenic shock despite MAP being within the usual target (65 mmHg). Furthermore, increased central venous pressure (CVP) is associated with higher mortality during cardiogenic shock. Considering venous congestion by measuring or estimating CVP is necessary to assess the effective perfusion pressure (MAP minus CVP) in order to protect against organ dysfunction. In this perspective, the MAP target should be increased by the value of the CVP.
The investigators hypothesize that personalizing the MAP target (to achieve an effective perfusion pressure of 65 mmHg) improves organ perfusion and survival during cardiogenic shock compared to the usual MAP target of 65 mmHg.
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
- •Aged ≥18 years
- •Cardiogenic shock state, according to the consensus definition,
- •SCAI (Society for Cardiovascular Angiography and Interventions) classification ≥ C
- •Consent from the patient or close relative / trusted person or emergency inclusion procedure
- •Benefiting fromciary of a social security scheme
排除标准
- •Catecholamine infusion for more than 24 consecutive hours;
- •CVP < 5 mm Hg at inclusion;
- •MAP > 70 mmHg at inclusion;
- •Chronic kidney disease stage G4 (defined by an eGFR between 15-29 ml/min/1.73 m²) or G5 (defined by an eGFR less than 15 ml/min/1.73 m²) according to the KDIGO CKD classification at inclusion;
- •Chronic dialysis or presence of renal replacement therapy criteria at inclusion ;
- •Recovered cardiopulmonary arrest within 7 days prior to inclusion;
- •Patient already on mechanical circulatory support at inclusion before enrollment (patients who receive support after inclusion will not be excluded);
- •Primary diagnosis of tamponade, pulmonary embolism, or septic shock;
- •Hypersensitivity to norepinephrine tartrate or to any of the following excipients: sodium chloride, hydrochloric acid or sodium hydroxide water for injectable preparations;
- •Absence of central venous access;
- •Known pregnancy or current breastfeeding;
- •Under legal guardianship, curatorship, or judicial protection.
研究组 & 干预措施
Personalized MAP
干预措施: Personalized MAP (Other)
Standard MAP
干预措施: Standard MAP (Other)
结局指标
主要结局
The primary endpoint will be a composite of mortality, use of cardiac mechanical circulatory support, and severe renal failure.
时间窗: 7 days and 28 days after randomization
次要结局
- Mortality in the intensive care unit (ICU), and in hospital(28 days and 90 days after randomization)
- Length of stay in the ICU and in the hospital(28 days and 90 days after randomization)
- Proportion of patients requiring cardiac mechanical circulatory support(28 days after randomization)
- Proportion of patients requiring renal replacement therapy(28 days after randomization)
- Proportion of patients with severe acute kidney injury (stage 2 and stage 3 according to KDIGO AKI classification)(7 days after randomization)
- Duration of inotrope and vasopressor support(28 days after randomization)
- Use of mechanical ventilation(28 days after randomization)
- Number of ventilator-free days(28 days after randomization)
- Evolution of the vasoactive inotropic score (VIS)(5 days after randomization)
- Evolution of lactate levels(5 days after randomization)
- Evaluation of mottling score(5 days after randomisation)
- Evaluation of capillary refill time(5 days after randomization)
- Evaluation of Sequential Organ Failure Assessment (SOFA) score(5 days after randomization)
- Proportion of patients with sustained ventricular and/or supraventricular arrhythmias(5 days after randomization)
- Proportion of patients with stroke, non-cerebral ischemia, new or recurrent myocardial infarction(28 days after randomization)
- Proportion of patients with major bleeding, defined according to the ISTH classification(28 days after randomization)
- Net clinical benefit at D28 (survival without thrombotic event or major bleeding).(28 days after randomization)
- Proportion of patients receiving new specific treatments after randomization during hospital stay(28 days after randomization)