The Effect of Simultaneous Renal Replacement Therapy on Extracorporeal Membrane Oxygenation Support for Cardiogenic Shock Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 262
- 试验地点
- 1
- 主要终点
- All-cause mortality
研究概览
简要总结
Extracorporeal membrane oxygenation (ECMO) is a temporary mechanical circulatory support device for cardiogenic shock (CS) patients. During ECMO support, renal replacement therapy (RRT) facilitate more rapid metabolic or uremic control and more effective prevention and management of fluid overload which happened in critical state. CS patients who are likely to receive ECMO support will be enrolled and randomized with a 1:1 allocation to a simultaneous RRT arm vs. standard care arm.
- The patients in the simultaneous RRT arm will receive RRT when ECMO is commenced.
- The patients in the standard care arm will not receive RRT when ECMO is commenced. Only when a patient demonstrates AKI and fulfills any one of the criteria of the conventional RRT indication during ECMO support or after ECMO weaning, conventional-indication RRT would be delivered.
The primary outcome is all-cause 30-day mortality after ECMO is commenced
详细描述
Background:
Extracorporeal membrane oxygenation (ECMO) is a temporary mechanical circulatory support device for cardiogenic shock (CS) patients. Patients with fluid overload (FO) and sever metabolic disorder in the early phase of ECMO support exhibit higher hospital mortality. Simultaneous renal replacement therapy (RRT) is routinely used to facilitate more rapid metabolic or uremic control and more effective prevention and management of fluid overload when ECMO is commenced in some ECMO centers registered in the Extracorporeal Life Support Organization (ELSO). However, high-quality evidence to support the strategy of simultaneous RRT during ECMO support is currently lacking. The investigators aim to perform a single center, randomized, controlled trial to evaluate the impact of simultaneous RRT on outcomes during ECMO support for CS patients.
Hypotheses:
The investigators hypothesize that simultaneous RRT with ECMO will improve survival, reduce morbidity, and shorten duration on ECMO support, duration on invasive ventilation, total days of ICU stay and hospitalization, and time to recovery from electrolyte disturbance.
Design:
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 and ≤ 70 years.
- •Admission to ICU.
- •Criteria for the diagnosis of CS as follows: (1) systolic blood pressure less than 90 mmHg for 30 min, a mean arterial pressure less than 65 mmHg for 30 min, or vasopressors required to achieve a blood pressure ≥ 90 mmHg; (2) pulmonary congestion or elevated left-ventricular filling pressures; and (3) signs of impaired organ perfusion with at least one of the following criteria: (a) altered mental status; (b) cold, clammy skin; (c) oliguria; and (d) increased serum lactate.
- •ECMO will supply cardiopulmonary support to the patient.
排除标准
- •Refusal of consent.
- •Received or decided to receive RRT before ECMO was commenced.
- •Fulfilled the criteria for Chronic Kidney Disease (either of the following present for >3 months): (1) Albuminuria (albumin excretion rate > 30 mg/24 hours; albumin-to-creatinine ratio > 30 mg/g); (2) urine sediment abnormalities; (3) electrolyte and other abnormalities due to tubular disorders; (4) abnormalities detected by histology; (5) structural abnormalities detected by imaging; and (6) history of kidney transplantation.
- •Received ECMO bridging to a long-term ventricle assist device or heart transplantation.
研究组 & 干预措施
Simultaneous RRT
The patients in the simultaneous RRT arm will receive RRT when ECMO is commenced.
干预措施: Simultaneous RRT (Procedure)
Standard care
The patients in the standard care arm will not receive RRT when ECMO is commenced. Only when a patient demonstrates AKI and fulfills any one of the criteria of the conventional RRT indication, RRT would be delivered.
干预措施: Standard care (Procedure)
结局指标
主要结局
All-cause mortality
时间窗: 30 days
次要结局
- Rate of infection(30 days)
- Duration on ECMO support(60 days)
- ICU length of stay(60 days)
- Rate of acute kidney injury(30 days)
- Rate of successful weaning from ECMO(30 days)
- Duration on invasive ventilation(60 days)
- Hospital length of stay(60 days)
- Time to recovery from electrolyte and metabolic disturbance(30 days)
研究者
Xiaotong Hou
Director of Center for Cardiac Intensive Care
Beijing Anzhen Hospital