Cardiogenic shock, Heart failure Acute severe heart failure
Conditions
Interventions
The LV unloading trial domain will study the effects of ECMO + IABP vs ECMO +
Impella vs ECMO alone on weaning success and will encompass three arms:
1. *ECMO alone arm*: VA ECMO without mechanical
Sponsors
Nederlandse Hartstichting
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Having received ECMO support for severe circulatory and/or respiratory insufficiency. - Age >= 18 years - Cardiogenic shock - Initiation of intra-aortic balloon pump (IABP) possible
Exclusion criteria
Exclusion criteria: - Raised objection during the deferred consent procedure - 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 - Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Successful ECMO weaning at 30 days, 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). For the physiological substudy: The difference in left ventricular end diastolic volume (as estimated by transesophageal echocardiography) measured at the first time point (after hemodynamic stabilization (defined by stable hemodynamic parameters such as blood pressure and heart rate, and adequate ECMO flow) and within 24h after ECMO initiation) in the cohort of patients supported by V-A ECMO with- versus without- IABP at baseline (mechanical ventilation set at clinical PEEP). For the VWF substudy: The primary endpoint of the VWF substudy will be the absolute difference in VWF:CB/Ag ratios between patients receiving V-A ECMO combined with IABP (pulsatile flow group) versus patients receiving V-A ECMO alone (continuous flow group) 24 hours after V-A ECMO initiation. These ratios were selected as they provide robust functional readouts of VWF integrity, comparable to high molecular weight multimer analysis. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.. Treatment failure defined by: insertion of an IABP (only in the ECMO alone arm), Impella (IABP unloading arm) or left atrial/ventricular vent (in all arms). 2. 30 day, 90 day, and 1 year mortality, 3. ECMO support duration, 4. ICU- and hospital- admission duration, 5. 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) during or until 24 hours after ECMO- or IABP-support, whichever comes last. (22) 6. Unplanned surgical or catheter based intervention of the leg(s) in which ECMO and/or IABP was inserted during, or until 24 hours after ECMO- or IABP-support, whichever comes last. 7. Time to lactate normalization (<2 mmol/L). 8. Time to first negative net fluid balance (counted per 24 hours). 9. The occurrence of continuous venovenous hemofiltration (dialysis) (CVVH(D)) initiation during ECMO support. 10. Course in PF ratio during ECMO support. 11. Duration of mechanical ventilation. Patients on mechanical ventilation via tracheostomy need to be 24 hours free of mechanical ventilation. 12. Left ventricular ejection fraction 30 days after ECMO initiation. 13. Time course in vasoactive inotropic score (VIS) during ECMO support 14. Quality of life (QoL on basis of EQ5D questionnaires) after 1 year. 15. Total health care costs based on validated questionnaires (iMCQ and iPCQ) at 6 months and 12 months follow up. For the physiological substudy: 1. Heart rate 2. Pulmonary artery catheter: pulmonary capillary wedge pressure, cardiac output, central venous pressure 3. Echocardiography: Left ventricular ejection fraction, TAPSE, VTI LVOT 4. Microcirculation measurements: e.g. perfused vessel density (PVD [mm/mm2], Total vessel density (TVD [mm/mm2]), Red blood cell velocity (RBCv) 5. Respiratory: FiO2, PEEP, Respiratory System Compliance (CRS) as the ratio between Vt/Dp. 6. Laboratory: delta NT-pro BNP For the VWF substu | — |
Countries
Belgium, Netherlands
Contacts
Public ContactC.L. Meuwese
Erasmus MC, Universitair Medisch Centrum Rotterdam
Outcome results
None listed