ECMO
Conditions
Keywords
ECMO, IABP, LV unloading
Brief summary
The goal of this multicenter, randomized trial is to compare early early left ventricular unloading by Intra-aortic Balloon Pump (IABP) versus conventional approach in patients with cardiogenic shock (CS) undergoing venoarterial extracorporeal membrane oxygenation (VA-ECMO). The main question it aims to answer is : • If left ventricular unloading by IABP as compared with the conventional approach will improve the outcomes in patients undergoing VA-ECMO.
Detailed description
The role of IABP combined with VA-ECMO in patients with CS remains unclear. Therefore, investigators will conduct a prospective randomized clinical trial to explore the effect of early IABP use for LV unloading after VA-ECMO on outcomes in patients with CS. Investigators will randomly assign 358 patients receiving peripheral VA-ECMO to the ECMO+IABP group (n=179) or the ECMO group (n=179). The primary end point was the 30-day mortality.
Interventions
OTHEREarly IABP use
Patients receive IABP for left ventricular unloading within 6 hours after VA-ECMO initiation.
Patients do not receive mechanical unloading within 6 hours after VA-ECMO initiation.
Sponsors
Beijing Anzhen Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age of ≥18 2. Cardiogenic shock(defined as a systolic blood pressure of less than 90 mm Hg for more than 30 minutes or the initiation of catecholamines to maintain a systolic pressure of more than 90 mm Hg, an arterial lactate level of more than 3 mmol per liter, and signs of impaired organ perfusion) 3. Successful implantation of VA-ECMO 4. Informed consent
Exclusion criteria
1. SCAI shock stage A or B 2. Presence of moderate to severe aortic insufficiency or aortic dissection 3. Severe peripheral vascular disease 4. Post-cardiotomy cardiogenic shock(non-CABG procedure) or bridging to cardiac procedure(heart transplantation or LVAD). 5. VA-ECMO for definite non-cardiac causes 6. Isolated right ventricular failure 7. V-A ECMO usage confined to the period during surgery or other interventions 8. Ischemic mechanical complications(eg Ventricular septal defect, papillary muscle rupture) 9. Extracorporeal cardiopulmonary resuscitation 10. LVAD, Impella or IABP in situ. 11. Severe bleeding 12. Terminal malignancy 13. Irreversible neurologic injury 14. Pregnancy or lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 30-day mortality | 30 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| weaning from VA-ECMO | 30 days | — |
| Rate of advanced mechanical unloading | 30 days | — |
| Left Ventricular Function of survivors | 30 days | — |
| In-hospital Mortality | 30 days | — |
| Day of Mechanical Circulatory Support Device Weaning | 30 days | — |
| Rate of pulmonary congestion on chest X-ray | 30 days | — |
| Duration of VA-ECMO | 30 days | — |
| Lactate clearance rate at 12 and 24 hours | 30 days | — |
| Relative decrease in vasoactive inotropic score(VIS) at 12 and 24 hours | 30 days | Vasoactive inotropic score (VIS), in µg/kg/min, was calculated as follows: dopamine + dobutamine + 100 epinephrine + 100 norepinephrine + 15×milrinone. Higher VIS predict worse outome. |
| Reduction in Myocardial Injury Biomarkers (cTnI/cTnT) | 30 days | — |
| Reduction in N-terminal pro-B-type Natriuretic Peptide (NT-proBNP) | 30 days | — |
| Rate of CRRT | 30 days | — |
| Rate of ventricular arrhythmia | 30 days | — |
| Rate of stroke | 30 days | — |
| Rate of bleeding | 30 days | BARC type III or V |
| Rate of limb ischemia | 30 days | ECMO side/ IABP side |
| Duration of mechanical ventilation | 30 days | — |
| Rate of infection | 30 days | With or without culture result |
| ICU length of stay | 30 days | — |
| Hospital length of stay | 30 days | — |
Countries
China
Contacts
CONTACTXiaotong Hou, MD, PhD
PRINCIPAL_INVESTIGATORXiaotong Hou, MD, PhD
Beijing Anzhen Hospital
Outcome results
None listed