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临床试验/NCT05788211
NCT05788211已完成不适用

Predicted Long Term Renal Outcome After Medical or Postcardiotomy Refractory Cardiogenic Shock Requiring Renal Replacement Therapy Concomitant With Venoarterial Extracorporeal Membrane Oxygenation

University Hospital, Bordeaux1 个研究点 分布在 1 个国家目标入组 93 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
已完成
发起方
入组人数
93
试验地点
1
主要终点
Complete renal recovery status according second definition

研究概览

简要总结

This retrospective study assesses long term renal outcome in patients having suffered medical or post cardiotomy refractory cardiogenic shock requiring renal replacement therapy (RRT) concomitant with veno-arterial extracorporeal membrane oxygenation (VA-ECMO).

The authors seek to establish for accurate definition of renal recovery status predicting poor long-term renal outcomes.

详细描述

Cardiogenic shock, defined as cardiac pump failure, is caused by many etiologies such as myocardial infarction, infectious diseases or post-cardiotomy. Mortality remains high and may reach 80% depending on etiologies and series ( 60% 30 days - mortality after post-cardiotomy cardiogenic shock). Extra Corporeal Life Support (ECLS) became a corner stone of refractory cardiogenic shock.

This low cardiac output syndrome leeds to associated organs failure whose renal function is the first being impaired. Severity partly depends on hemodynamic instability duration and intensity. Sixty percent of patients under ECLS develop acute kidney injury (AKI) and two third of them will need renal replacement therapy (RRT), representing 40 percent of the ECLS population. In addition, RRT introduction is associated with higher mortality.

In the surviving patients, there is a growing interest on long term renal outcomes. Few retrospective studies already indicate a higher 1- and 2-years incidence of major adverse kidney events (MAKE: overall mortality or dialysis dependance or doubling serum creatinine) in case of association of RRT and ECLS. Also, 90 days renal recovery status may be correlated with 2.9 higher risk of MAKE at 3 years.

Nowadays, preventing those long term renal adverse events should be considered as a priority during intensive care unit stay. Optimizing renal recovery appears to be the leading strategy in clinical practice.

There is a lack of standardization in defining renal recovery leading to incomparability of studies. To investigators knowledge, there is no validated definition of renal recovery in patients undergoing combined veno-arterial mode of extracorporeal oxygenation membrane (VA mode of ECMO) and renal replacement therapy.

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

  • Patients over 18 years old
  • Medical or post cardiotomy refractory cardiogenic shock
  • Patients requiring concomitant renal replacement therapy (RRT) and venoarterial extracorporeal membrane oxygenation (VA-ECMO)

排除标准

  • Congenital heart diseases
  • Severe pre operative chronic kidney disease (eGFR < 30ml/min/1,73m2)
  • Death within the first 7 days of ECMO
  • Patient receiving non-concomitant ECMO and RRT

结局指标

主要结局

Complete renal recovery status according second definition

时间窗: 90 days from AKI start

decrease in serum creatinine level below 1.25 fold its basal value

Complete renal recovery status according first definition

时间窗: 90 days from AKI (acute Kidney Injury) start

decrease in serum creatinine level below 1.5 fold its basal value

Long term renal outcome

时间窗: 2 years from AKI start

proportion of patient meeting a composite criterion (overall mortality or dialysis dependency or doubling of basal serum creatinine)

次要结局

  • vital status(1 year, 2 years from AKI start)
  • renal replacement therapy status(1 year, 2 years from AKI start)
  • MAKE incidence(hospital discharge, an average of 60 days from AKI start)
  • Determination of risk factors (baseline characteristics, clinical features, medications and nephrotoxic use, ECMO parameters, RRT parameters) associated with incomplete renal recovery status(up to 90 days from AKI start)
  • Determination of risk factors (baseline characteristics, clinical features, medications and nephrotoxic use, ECMO parameters, RRT parameters, 90 days renal recovery status) associated with MAKE(up to 2 years from AKI start)
  • Renal recovery status(hospital discharge, an average of 60 days from AKI start)

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

Head of department of Cardiovascular Anesthesia and Critical care

University Hospital, Bordeaux

研究点 (1)

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