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临床试验/NCT05465200
NCT05465200招募中不适用

Coordinated Treatment of Cardiogenic Shock Patients in Lower Silesia, Poland

Wroclaw Medical University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年1月1日最近更新:
适应症

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:

  1. Systolic blood pressure < 90 mmHg for > 30 minutes or need for vasopressors use to maintain systolic blood pressure > 90 mmHg
  2. Lactate level > 2.0 mmol/L
  3. Pulmonary capillary wedge pressure or left ventricle end diastolic pressure > 15 mmHg (excluding pulmonary embolism)
  4. Cardiac Index ≤ 2.2 l/min/m2
  5. Diuresis < 30 ml/h
  6. Clinical signs of peripheral hypoperfusion

Data required by "hub" from "spoke"

  1. Echocardiography with data on left and right ventricle function
  2. Current aortic and mixed venous blood gases
  3. 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)
  4. Peripheral blood tests including liver and kidney function, morphology, troponin, natriuretic peptides
  5. Currently used and possible for use vascular accesses
  6. 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

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

发起方
Wroclaw Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Wiktor Kuliczkowski

Head of Catheterization Laboratory

Wroclaw Medical University

研究点 (1)

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Lower Silesia Cardiogenic Shock Initiative | 临床试验