Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ECMO+IABP group | Experimental | Patients receive IABP for left ventricular unloading within 6 hours after VA-ECMO initiation. |
|
| ECMO group | Active Comparator | Patients do not receive mechanical unloading within 6 hours after VA-ECMO initiation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early IABP use | Other | Patients receive IABP for left ventricular unloading within 6 hours after VA-ECMO initiation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 30-day mortality | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| weaning from VA-ECMO | 30 days | |
| Rate of advanced mechanical unloading | 30 days | |
| Left Ventricular Function of survivors |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaotong Hou, MD, PhD | Contact | 010-64456631 | xt.hou@ccmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Xiaotong Hou, MD, PhD | Beijing Anzhen Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Anzhen Hospital | Recruiting | Beijing | Beijing Municipality | 100029 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Conventional approach | Other | Patients do not receive mechanical unloading within 6 hours after VA-ECMO initiation. |
|
| 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 | 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. | 30 days |
| 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 | BARC type III or V | 30 days |
| Rate of limb ischemia | ECMO side/ IABP side | 30 days |
| Duration of mechanical ventilation | 30 days |
| Rate of infection | With or without culture result | 30 days |
| ICU length of stay | 30 days |
| Hospital length of stay | 30 days |