Cardiogenic Shock
Conditions
Keywords
veno-arterial extracorporeal membrane oxygenation (VA-ECMO), hemoperfusion, inflammatory factor
Brief summary
Extracorporeal membrane oxygenation (ECMO) is a temporary mechanical circulatory support device for cardiogenic shock (CS) patients. During extracorporeal membrane oxygenation (ECMO) support, the inflammatory response is intense and complex. It may cause infection, cell damage, organ dysfunction and even death. Hemoperfusion can adsorb inflammatory factors and reduce the inflammatory reaction. CS patients who are likely to receive veno-arterial extracorporeal membrane oxygenation (VA-ECMO) support will be enrolled and randomized with a 1:1 allocation to a simultaneous hemoperfusion arm vs. standard care arm. 1. The patients in the simultaneous hemoperfusion arm will receive hemoperfusion when extracorporeal membrane oxygenation (ECMO) is commenced. 2. The patients in the standard care arm will not receive hemoperfusion when extracorporeal membrane oxygenation (ECMO) is commenced. The primary outcome is the change of plasma interleukin (IL)-6 level after hemoperfusion is commenced.
Interventions
DEVICEhemoperfusion
The patients in the simultaneous hemoperfusion arm will receive hemoperfusion when extracorporeal membrane oxygenation (ECMO) is commenced. veno-arterial extracorporeal membrane oxygenation (VA-ECMO) patients treat with hemoperfusion three times in a row，each time for 6 hours.
Sponsors
Beijing Anzhen Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 and ≤ 75 years. 2. Admission to ICU. 3. Criteria for the diagnosis of CS as follows: (1) systolic blood pressure less than 90 mmHg for 30 min, a mean arterial pressure less than 65 mmHg for 30 min, or vasopressors required to achieve a blood pressure ≥ 90 mmHg; (2) pulmonary congestion or elevated left-ventricular filling pressures; and (3) signs of impaired organ perfusion with at least one of the following criteria: (a) altered mental status; (b) cold, clammy skin; (c) oliguria; and (d) increased serum lactate. 4. ECMO will supply cardiopulmonary support to the patient 5. The patients will be enrolled and randomized when ECMO is commenced less than 24 hours.
Exclusion criteria
1. Refusal of consent. 2. Active hemorrhage or thrombocytopenic purpura 3. BMI≥40 4. Received ECMO bridging to a long-term ventricle assist device or heart transplantation. 5. Infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change of plasma interleukin (IL)-6 level | 3 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality | 30 days | — |
| Rate of Multiple organ dysfunction syndrome (MODS) | 30 days | — |
| Rate of infection | 30 days | Any kinds of infection |
| Duration on extracorporeal membrane oxygenation (ECMO) support | 60 days | — |
| change of other inflammatory factor level | 3 days | plasma interleukin (IL)-1β、8、10（pg/ml） |
| Duration on invasive ventilation | 60 days | — |
| ICU length of stay | 60 days | — |
| Hospital length of stay | 60 days | — |
| Rate of adverse event | 30 days | — |
| Rate of successful weaning from extracorporeal membrane oxygenation (ECMO) | 30 days | The circulation doesn't deteriorate in 24 hours since weaning from ECMO |
Countries
China
Contacts
Primary ContactXiaotong Hou, PhD., Md.
Backup ContactDannuo Han
Outcome results
None listed