Coordinated Treatment of Cardiogenic Shock Patients in Lower Silesia, Poland
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
- 30-days all-cause mortality
研究概览
简要总结
LSCSI is a Hub&Spoke project with the main aim to improve the outcome of patients with cardiogenic shock in Lower Silesia region, Poland. It consists of one "hub" which is Wroclaw University Hospital and eleven "spokes" which are eleven cardiology departments situated in Lower Silesian Voivodeship. The consortium have unified protocol defining which cardiogenic shock patient and when should be transferred to the "hub" for enhanced treatment options including durable mechanical circulatory support or heart transplant. The "hub" have 7/24 Shock Team on-site supplied with a protocol how to proceed with "spoke" transferred patients including decision making on which mechanical circulatory support implant with subsequent de-escalation or escalation pathway.
详细描述
LSCSI is a Hub&Spoke project with the main aim to improve the outcome of patients with cardiogenic shock in Lower Silesia region, Poland. It consists of one "hub" which is Wroclaw University Hospital and eleven "spokes" which are eleven cardiology departments situated in Lower Silesian Voivodeship. The consortium have unified protocol defining which cardiogenic shock patient and when should be transferred to the "hub" for enhanced treatment options including durable mechanical circulatory support or heart transplant.
Shared cardiogenic shock definition:
- Systolic blood pressure < 90 mmHg for > 30 minutes or need for vasopressors use to maintain systolic blood pressure > 90 mmHg
- Lactate level > 2.0 mmol/L
- Pulmonary capillary wedge pressure or left ventricle end diastolic pressure > 15 mmHg (excluding pulmonary embolism)
- Cardiac Index ≤ 2.2 l/min/m2
- Diuresis < 30 ml/h
- Clinical signs of peripheral hypoperfusion
Data required by "hub" from "spoke"
- Echocardiography with data on left and right ventricle function
- Current aortic and mixed venous blood gases
- Pulmonary artery catheter measurements including calculation of cardiac power, pulmonary artery pulsatile index, cardiac output, cardiac index, pulmonary artery wedge pressure, pulmonary vascular resistance, systemic vascular resistance (excluding pulmonary embolism)
- Peripheral blood tests including liver and kidney function, morphology, troponin, natriuretic peptides
- Currently used and possible for use vascular accesses
- For pulmonary embolism: computed tomography of pulmonary arteries
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 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fulfilled definition of cardiogenic shock
- •Age 18 - 60 years
- •Shock duration below 24 hours
排除标准
- •History of cardiac arrest with anoxemic brain injury
- •Irreversible multiorgan failure
- •End stage of chronic diseases other than heart failure
- •Neoplastic disease
- •Lack of vascular access
结局指标
主要结局
30-days all-cause mortality
时间窗: 30 days
All-cause mortality
次要结局
- 12-months mortality(12 months)
研究者
Wiktor Kuliczkowski
Head of Catheterization Laboratory
Wroclaw Medical University
