Randomized Embedded Multifactorial Adaptive Platform in ExtraCorporeal Membrane Oxygenation (REMAP ECMO) - Left Ventricular Unloading Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 430
- 试验地点
- 21
- 主要终点
- Physiological substudy: End diastolic volume
研究概览
简要总结
REMAP ECMO is a registry based platform in which multiple response adaptive randomized clinical trials (trial domains) will be embedded. These trial domains will, in a perpetual way, study the effects of a range of patient management strategies which aim to improve VA ECMO weaning success. A first trial domain will address the effects of left ventricular (LV) unloading through intra-aortic balloon pumping on weaning succes in VA ECMO supported patients.
详细描述
ExtraCorporeal Membrane Oxygenation (ECMO) is increasingly used but remains associated with high weaning failure- and mortality- rates. This seems in part attributable to a knowledge gap on how to properly manage ECMO and its related therapies as current knowledge and treatment protocols are based on observational studies and expert opinions. The "Randomized Embedded Multifactorial Adaptive Platform in ECMO" (REMAP ECMO) study was developed to study, in an efficient and randomized way, different ECMO related patient management issues and will consist of two parts:
- A patient registry that will serve for quality monitoring and observational studies of ECMO patients being treated in participating centers.
- Embedded within the registry, multiple response adaptive randomized clinical trials (trial domains) which aim to evaluate the effectiveness of a range of therapeutic interventions on ECMO weaning success. These interventions all have in common that they are all already used in ECMO care but their use depends on center and/or doctors preferences as no high quality (randomized) evidence guiding their indication, timing and management exists.
- LV unloading trial A first trial domain to be initiated within the REMAP ECMO platform will address the effects of left ventricular (LV) unloading, through application of an intra-aortic balloon pump (IABP), on weaning success in the setting of venoarterial (VA) ECMO. The rationale of this trial domain is based on the increase in LV loading conditions, as induced by VA ECMO, which could lead to pulmonary edema, intracardiac thrombosis and even death. These serious sequelae could possibly be prevented by adding IABP as adjunct to VA ECMO therapy.
- Physiological substudy on IABP as adjunct to V-A ECMO
A nested physiological observational substudy within the ongoing REMAP ECMO RCT, using the trial arms where patients are randomized between receiving V-A ECMO with or without IABP in the Erasmus Medical Center Rotterdam. The substudy aims to evaluate the physiological effects of IABP in conjunction with V-A ECMO on respiratory and hemodynamic parameters. The substudy consists of two parts:
- Microcirculation and Macrocirculation: This part investigates the impact of IABP on both microcirculation and macrocirculation in the setting of V-A ECMO.
- PEEP as an Unloading Modality: This part examines the effect of Positive End-Expiratory Pressure (PEEP) as an unloading modality during a decremental PEEP trial in patients receiving V-A ECMO, either with or without IABP.
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
盲法说明
No masking is possible as the device is visible after placement.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •for the registry backbone:
- •Having received ECMO support for severe circulatory and/or respiratory insufficiency
- •Inclusion Criteria for the LV unloading trial domain (VA ECMO + IABP vs VA ECMO alone):
- •Cardiogenic shock
- •Having received VA ECMO support for severe circulatory (and respiratory insufficiency).
- •Age ≥ 18 years
- •Initiation of LV unloading (IABP or Impella) possible ≤ 8 hours after ECMO initiation
排除标准
- •for the registry backbone
- •Objection to participation in the registry by the patient and/or proxy
- •VA ECMO usage confined to the period during surgery or another intervention (the VA ECMO was removed at the end of the intervention in the operation room).
- •Exclusion criteria for the LV unloading trial domain (VA ECMO + IABP vs VA ECMO alone)
- •No (deferred) informed consent provided by the patient and/or proxy.
- •Pregnancy
- •ECMO usage confined to the period during surgery or another intervention (the ECMO was removed at the end of the intervention).
- •Isolated right ventricular failure (e.g. due to pulmonary embolism).
- •Left ventricular assist device (LVAD), Impella or IABP in situ.
- •Ventricular septal defect or papillary muscle rupture as the cause of shock.
- •Thoracic or abdominal aortic dissection.
- •Moderate or severe aortic regurgitation
- •Mechanical prosthesis in mitral valve position
研究组 & 干预措施
IABP unloading arm
This group of patients will receive an intra-aortic balloon pump (IABP) as an adjunct to VA ECMO support. When allocated to the IABP unloading arm, patients must receive an IABP within 8 hours after VA ECMO initiation.
干预措施: Intra-aortic balloon pump (Device)
ECMO alone arm
This group of patients will receive VA ECMO support without left ventricular unloading device after randomization.
结局指标
主要结局
Physiological substudy: End diastolic volume
时间窗: within 24 hours after ECMO initiation
End diastolic volume as assessed by echocardiography
ECMO weaning success
时间窗: 30 days
Proportion of patients successfully weaned from VA ECMO at 30 days being defined by; a) being alive, b) without ECMO, IABP or Impella support, and c) not having received a heart transplantation or left ventricular assist device (LVAD).
次要结局
- Duration of mechanical ventilation.(Until 30 days after ECMO initiation.)
- Time course in NT-pro BNP during ECMO support.(Until 30 days after ECMO initiation.)
- Quality of life at 1 year(1 year after ECMO initiation)
- Total health care costs(6 and 12 months after ECMO initiation)
- Treatment failure(During ECMO support)
- Unplanned surgical or catheter based intervention of the leg(s)(Until 30 days after ECMO initiation)
- 30 day, 90 day and 1 year mortality(30 days, 90 days and 1 year after ECMO initiation)
- Major bleeding events(Until 30 days after ECMO initiation)
- Physiological substudy: microcirculation measurements(24 and 48 hours after ECMO initiation)
- ECMO support duration(Until 30 days after ECMO initiation)
- Time to lactate normalization(Until 30 days after ECMO initiation)
- Time to first negative net fluid balance(Until 30 days after ECMO initiation)
- The occurrence of continuous venovenous hemofiltration initiation during ECMO support(Until 30 days after ECMO initiation)
- Course in PF ratio(Until 30 days after ECMO initiation.)
- Left ventricular ejection fraction 30 days after ECMO initiation.(At 30 days after ECMO initiation.)
- Hospital readmission rate(1 year)
- Physiological substudy: pulmonary artery catheter parameters(24 and 48 hours after ECMO initiation)
- Time course in vasoactive inotropic score (VIS) during ECMO support(Until 30 days after ECMO initiation.)
- Physiological substudy: Heart rate(24 and 48 hours after ECMO initiation)
- Physiological substudy: Echocardiography(24 and 48 hours after ECMO initiation)
- Physiological substudy: respiratory parameters(24 and 48 hours after ECMO initiation)
- Physiological substudy: delta NT-pro BNP(24 and 48 hours after ECMO initiation)
研究者
Christiaan Meuwese
Principal investigator
Erasmus Medical Center