French Observatory on the Management of Cardiogenic Shock in 2016
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 777
- 试验地点
- 1
- 主要终点
- Mortality at day 30
研究概览
简要总结
Cardiogenic shock (CS) is defined as an organ hypoperfusion secondary to low cardiac output. Catches diagnostic management, and therapeutic monitoring of these patients remain highly variable from one center to another and even from one doctor to another within the same team. The management protocols are often not standardized or non-existent.
It appears therefore necessary to make an inventory of the management practices of the CS in France in 2016, prerequisite to a common work of standardization of practices and the creation of specialized networks to support these complex patients.
详细描述
The Observatory FRENSHOCK proposes to set up a cohort of 500 patients recruited prospectively over a period of 6 months.
Patients will be followed up at 1 month and 1 year Patients should have agreed to participate in the observatory, knowing that participation or refusal to participate will not alter the therapeutic attitude of the physician responsible for the patient. The study of phenotypic characteristics will not change the therapeutic approach of the medical teams.
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
- •Informed consent
- •Cardiogenic shock authenticated by the existence of at least one positive test for each of the following three parts:
- •(A) Low cardiac output (1 criterion necessary and sufficient):
- •Clinic: SBP <90mmHg and / or need to maintain inotropic or vasopressor to maintain SBP> 90 mmHg
- •Echocardiography: IC <2.2L / min / m2 and / or LVEF <30%
- •Hemodynamics by Swan Ganz catheterization or right: IC 2.2 l / min / m2 (B) elevation of pulmonary pressure / left surcharge (1 criterion necessary and sufficient):
- •Clinical (IVD and abortion);
- •Radiological (Surcharge on RT or chest CT);
- •Organic (NTproBNP> 900pg / ml or BNP> 400pg / ml);
- •Echocardiography (E / A> 2 if LVEF <45% or E / Ea> 13 if normal LVEF, or PAPS> 35mmHg and / or TDE <150ms and / or Ap-Am> 30ms and / or E / 2 Vp≥ , 5);
- •Right Swan Ganz catheterization or (pulmonary capillary pressures> 15mmHg and / or mPAP> 25mmHg)
- •(C) Organs malperfusion (1 criterion necessary and sufficient):
- •Clinic: oliguria <30ml / kg / h, mottling, consciousness disorders)
- •Organic: arterial lactate> 2 mmol / L, liver failure, kidney failure
排除标准
- •Final diagnosis retained other than cardiogenic shock
- •Cardiac arrest without spontaneous activity in the hospital management
- •Post-cardiotomy cardiogenic shock
- •Deprived of liberty patient
- •Refusal or lack of consent
结局指标
主要结局
Mortality at day 30
时间窗: 30 days
Death rate at 30 days of follow-up
次要结局
- Analysis of mortality at day 30 by subgroup on age, sex, NYHA grade, initial etiology(30 days)
- Mortality at 1 year(1 year)