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临床试验/NCT05309980
NCT05309980已完成不适用

Outcomes in CArdiogenic SHock Patients Treated by MEchanical Circulatory suppoRt devicE : Impact of Shock Team

University Hospital, Bordeaux1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2021年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
250
试验地点
1
主要终点
Vital status

研究概览

简要总结

In this before-after monocenter study, the authors teste the hypothesis that the implementation of a dedicated shock team could improve the outcome of patients with refractory cardiogenic shock assisted by mechanical circulatory support.

详细描述

Short Term Mechanical Circulatory Support (STMCS) are the last resort therapeutics when refractory cardiogenic shock occurs. Growing technical possibilities like impella make the right choice at the right time challenging. At Bordeaux University Hospital, we have gathered the main protagonists which are the surgeon, the interventional cardiologist,and the intensivist as a shock team in January 2013. From that time, diagnosis of refractory cardiogenic shock triggers a multidisciplinary meeting driven by a common algorithm. The objective of this study is to perform a before-after comparison between decision of STMCS for refractory cardiogenic shock without shock team from january 2007 to january 2013 and after implementation of the shock team from April 2013 to April 2019.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of cardiogenic shock
  • >1 sign of refractory cardiogenic shock : Dobutamine >10µg/kg/mn, epinephrine>0.25µg/kg/mn or Milrinone > 0.5µg/kg/mn ; ScvO2<55% ; pO2/FiO2<100
  • No major counter indication to short term mechanical circulatory support : SOFA score > 15, prolonged cardiac arrest, severe chronic disease, direct LVAD implantation or heart transplantation, counter indication for systemic anticoagulation

排除标准

  • Age < 18years
  • Post cardiotomy cardiogenic shock
  • Implantation of Impella 2.5 alone
  • Implantation of Intra Aortic Balloon Pump alone

结局指标

主要结局

Vital status

时间窗: One year after short term mechanical circulatory support initiation

Proportion of patients alive

次要结局

  • Vital status(6 months after short term mechanical circulatory support initiation)
  • Long term mechanical circulatory support(up to intensive care unit discharge, an average of 15 days)
  • Heart transplantation(up to intensive care unit discharge, an average of 15 days)
  • Weaning from short term mechanical circulatory support(up to seven days from weaning attempt)
  • Stroke(through short term mechanical circulatory support weaning, an average of 6 days)
  • Lenght of stay(up to one year)
  • New renal replacement therapy(up to intensive care unit discharge, an average of 15 days)
  • Limb ischaemia(through short term mechanical circulatory support weaning, an average of 6 days)
  • Short term mechanical circulatory support duration(through short term mechanical circulatory support weaning, an average of 6 days)
  • Severe haemorrage(through short term mechanical circulatory support weaning, an average of 6 days)
  • Extra Corporeal Membrane Oxygenation circuit clotting(through short term mechanical circulatory support weaning, an average of 6 days)
  • Sepsis(up to intensive care unit discharge, an average of 15 days)

研究者

发起方
University Hospital, Bordeaux
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alexandre OUATTARA

MD, PhD

University Hospital, Bordeaux

研究点 (1)

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