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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.
The primary outcome is the change of plasma interleukin (IL)-6 level after hemoperfusion is commenced.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| hemoperfusion | Experimental | 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. |
|
| standard care | No Intervention | The patients in the standard care arm will not receive hemoperfusion when lextracorporeal membrane oxygenation (ECMO) is commenced. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hemoperfusion | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| change of plasma interleukin (IL)-6 level | 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| change of other inflammatory factor level | plasma interleukin (IL)-1β、8、10(pg/ml) | 3 days |
| change of other inflammatory factor level | tumor necrosis factor α (TNF-α)(fmol/ml) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaotong Hou, PhD., Md. | Contact | 86 18911662932 | xt.hou@ccmu.edu.cn | |
| Dannuo Han | Contact | 13720055429 | handannuo@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Dannuo Han | Beijing Anzhen Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Cardiac Intensive Care, Beijing Anzhen Hospital, Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100029 | China |
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| ID | Term |
|---|---|
| D012770 | Shock, Cardiogenic |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D006464 | Hemoperfusion |
| ID | Term |
|---|---|
| D017582 | Renal Replacement Therapy |
| D013812 | Therapeutics |
| D016060 | Sorption Detoxification |
| D005112 | Extracorporeal Circulation |
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|
| 3 days |
| change of other inflammatory factor level | C-reactive protein (CRP)(mg/dl) | 3 days |
| All-cause mortality | 30 days |
| Rate of Multiple organ dysfunction syndrome (MODS) | 30 days |
| Rate of infection | Any kinds of infection | 30 days |
| Duration on extracorporeal membrane oxygenation (ECMO) support | 60 days |
| Rate of successful weaning from extracorporeal membrane oxygenation (ECMO) | The circulation doesn't deteriorate in 24 hours since weaning from ECMO | 30 days |
| Duration on invasive ventilation | 60 days |
| ICU length of stay | 60 days |
| Hospital length of stay | 60 days |
| Rate of adverse event | 30 days |
| D014652 |
| Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D012769 | Shock |
| D013514 | Surgical Procedures, Operative |