Evaluation of Integrated Versus Parallel Continuous Renal Replacement Therapy Connection in ECMO Patients: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 158
- 试验地点
- 10
- 主要终点
- Hemofilter change rate
研究概览
简要总结
Extracorporeal membrane oxygenation (ECMO) is an extra-corporeal assistance used in case of respiratory or circulatory failure. In case of circulatory failure, ECMO is in the veno-arterial configuration (VA-ECMO). VA-ECMO patients are at high risk of developing acute kidney injury (AKI) and renal replacement therapy (RRT) may be needed in 50% of ECMO patients. Although the administration of RRT in ECMO patients has major implications, no specific recommendations are currently available. The 2020 Kidney Disease: Improving Global Outcomes (KDIGO) international conference identified the evaluation of RRT in these ECMO patients as a research priority.
In 2023, the two main configurations used to administer RRT in ECMO patients are an independent delivery on a separate vascular access (parallel connection) or an integration of the RRT machine directly into the ECMO circuit (integrated connection). The integrated connection may reduce infectious and bleeding complications associated with the use of a second vascular access. However, it can expose the hemofilter and circuit to excessive positive pressures that can trigger pressure alarms in the RRT machine and expose the patient to a theoretical risk of air embolism or hemolysis. Furthermore, there is currently no robust data comparing the hemofilter lifespan with the parallel or with the integrated connection, although the filter lifespan is a crucial parameter to assess the quality of the RRT delivery in the ICU. The investigators recently performed a survey of practices in this context of ECMO patients. The investigators found that both strategies (parallel and integrated connection) are widely used and can be seen as common patient care.
The hypothesis tested in this study is the following: when RRT is integrated to the ECMO circuit, the hemofilter lifespan is non inferior to the one when RRT is delivered on a separate vascular access. Only VA-ECMO patients will be enrolled in this trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged above 18 years
- •Patient on VA-ECMO who requires the initiation of continuous RRT during VA-ECMO treatment
- •Patient with a foreseeable length of stay in intensive care greater than 24 hours
排除标准
- •Patient who does not have a vascular capital allowing for the insertion of a new dialysis catheter to administer RRT and therefore cannot be randomized to the parallel connection group
- •High pressures monitored on ECMO not allowing direct RRT catherter on ECMO
- •Pregnant, parturient, or breastfeeding women
- •Patient deprived of liberty by a judicial or administrative decision
- •Patient under psychiatric care
- •Patient subject to a legal protection measure (guardianship, curators)
- •Patient not affiliated to a social security system
- •Patient participating in another interventional research study in the field of extra purification renal
结局指标
主要结局
Hemofilter change rate
时间窗: Duration of RRT associated with VA-ECMO up to 60 days
To assess whether integrated RRT connection in VA-ECMO patients results in a non-inferior hemofilter change rate compared to the parallel connection. The hemofilter change rate is defined as the number of hemofilter replacements observed during the period between the start and the end of the RRT session, normalized by the duration of the session.
次要结局
- Number of days spent in intensive care unit(Duration of RRT associated with VA-ECMO up to 60 days)
- Number of air embolism(Duration of RRT associated with VA-ECMO up to 60 days)
- Proportion of early hemofilter thromboses(Duration of RRT associated with VA-ECMO up to 60 days)
- Number of bleeding complications(Duration of RRT associated with VA-ECMO up to 60 days)
- Proportion of ECMO circuit thromboses(Duration of RRT associated with VA-ECMO up to 60 days)
- Number of hemolysis(Duration of RRT associated with VA-ECMO up to 60 days)
- Proportion of hemofilter thromboses(Duration of RRT associated with VA-ECMO up to 60 days)
- Down-time(Duration of RRT associated with VA-ECMO up to 60 days)
- Renal function according to KDIGO stage(At hospital discharge up to 60 days after admission)
- Number of infectious complications(Duration of RRT associated with VA-ECMO up to 60 days)
- Death(At 30 days)