A Study on the Effects of Left Ventricular Unloading in the Setting of VA ECMO Support
- Conditions
- Cardiogenic Shock
- Interventions
- Device: Intra-aortic balloon pump
- Registration Number
- NCT05913622
- Lead Sponsor
- Erasmus Medical Center
- Brief Summary
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.
- Detailed Description
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:
1. A patient registry that will serve for quality monitoring and observational studies of ECMO patients being treated in participating centers.
2. 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:
1. Microcirculation and Macrocirculation: This part investigates the impact of IABP on both microcirculation and macrocirculation in the setting of V-A ECMO.
2. 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.
Endpoints in both substudies that can be assessed blindly will be evaluated by an assessor who is blinded to the assigned treatment arm and the objectives of the substudy
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 430
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description IABP unloading arm Intra-aortic balloon pump 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.
- Primary Outcome Measures
Name Time Method Physiological substudy: End diastolic volume within 24 hours after ECMO initiation End diastolic volume as assessed by echocardiography
ECMO weaning success 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).
- Secondary Outcome Measures
Name Time Method Duration of mechanical ventilation. Until 30 days after ECMO initiation. Duration of mechanical ventilation. Patients on mechanical ventilation via tracheostomy need to be 24 hours free of mechanical ventilation.
Time course in NT-pro BNP during ECMO support. Until 30 days after ECMO initiation. Time course in NT-pro BNP during ECMO support.
Quality of life at 1 year 1 year after ECMO initiation Quality of life on basis of EQ5D questionnaires
Total health care costs 6 and 12 months after ECMO initiation Total healthcare costs in euros are determined by using the International Medical Consumption Questionnaire (iMCQ) and the calculated costs after 6 and 12 months of follow up
Treatment failure During ECMO support The proportion of patients in whom LV unloading therapy was escalated. Escalation is defined by the insertion of an IABP (only in the VA ECMO alone arm), or Impella or left vent (IABP unloading arm or VA ECMO alone arm).
Unplanned surgical or catheter based intervention of the leg(s) Until 30 days after ECMO initiation Unplanned surgical or catheter based intervention of the leg(s) in which ECMO and/or IABP or Impella was inserted until 30 days after ECMO initiation.
30 day, 90 day and 1 year mortality 30 days, 90 days and 1 year after ECMO initiation Mortality rate at 30 days, 90 days and 1 year after ECMO initiation
Major bleeding events Until 30 days after ECMO initiation The occurrence of major bleeding events (fatal, in a critical area (intracranial, intraspinal, or intraocular), requiring intervention (coiling or surgery) and/or transfusion of ≥3 packed cells) until 30 days after VA ECMO initiation.
Physiological substudy: microcirculation measurements 24 and 48 hours after ECMO initiation Microcirculation measurements: Perfused vessel density (PVD \[mm/mm2\], Total vessel density (TVD \[mm/mm2\]
ECMO support duration Until 30 days after ECMO initiation The duration of ECMO support in days
Time to lactate normalization Until 30 days after ECMO initiation Time to lactate normalization (\<2 mmol/L).
Time to first negative net fluid balance Until 30 days after ECMO initiation Time to first negative net fluid balance (calculated per 24 hours).
The occurrence of continuous venovenous hemofiltration initiation during ECMO support Until 30 days after ECMO initiation The occurrence of continuous venovenous hemofiltration (dialysis) (CVVH(D)) initiation during ECMO support.
Course in PF ratio Until 30 days after ECMO initiation. Course in PaO2/FiO2 (PF) ratio (PaO2 divided by FiO2 provided)
Left ventricular ejection fraction 30 days after ECMO initiation. At 30 days after ECMO initiation. Left ventricular ejection fraction 30 days after ECMO initiation.
Hospital readmission rate 1 year The number of hospital readmissions based on the information provided in the international Medical Consumption Questionnaire (iMCQ)
Physiological substudy: pulmonary artery catheter parameters 24 and 48 hours after ECMO initiation pulmonary artery catheter parameters: pulmonary capillary wedge pressure, cardiac output, central venous pressure
Time course in vasoactive inotropic score (VIS) during ECMO support Until 30 days after ECMO initiation. Time course in vasoactive inotropic score (VIS) during ECMO support
Physiological substudy: Heart rate 24 and 48 hours after ECMO initiation The average heart rate measured during 5 minutes
Physiological substudy: Echocardiography 24 and 48 hours after ECMO initiation Echocardiography: LV ejection fraction, TAPSE, VTI LVOT
Physiological substudy: respiratory parameters 24 and 48 hours after ECMO initiation Respiratory: FiO2, PEEP, Respiratory System Compliance (CRS) as the ratio between Vt/Dp.
Physiological substudy: delta NT-pro BNP 24 and 48 hours after ECMO initiation delta NT-pro BNP
Trial Locations
- Locations (8)
Amphia hospital
🇳🇱Breda, Brabant, Netherlands
Catharina hospital
🇳🇱Eindhoven, Brabant, Netherlands
Amsterdam University Medical Center
🇳🇱Amsterdam, Noord Holland, Netherlands
Haga ziekenhuis
🇳🇱Den Haag, Zuid Holland, Netherlands
Leiden University Medical Center
🇳🇱Leiden, Zuid Holland, Netherlands
Erasmus Medical Center
🇳🇱Rotterdam, Zuid Holland, Netherlands
Antonius hospital
🇳🇱Nieuwegein, Utrecht, Netherlands
University Medical Center Utrecht
🇳🇱Utrecht, Netherlands