Hemoperfusion in Extracorporeal Membrane Oxygenation (ECMO) Patients

Study Overview
=================
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. The patients in the simultaneous hemoperfusion arm will receive hemoperfusion when extracorporeal membrane oxygenation (ECMO) is commenced. 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.

Official Title
-----------------
A Randomized, Controlled Trial: Hemoperfusion in Extracorporeal Membrane Oxygenation (ECMO) Patients

Conditions
-----------------
Cardiogenic Shock

Intervention / Treatment
-----------------
* Device: hemoperfusion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 and ≤ 75 years. Admission to ICU. 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. ECMO will supply cardiopulmonary support to the patient The patients will be enrolled and randomized when ECMO is commenced less than 24 hours. Exclusion Criteria: Refusal of consent. Active hemorrhage or thrombocytopenic purpura BMI≥40 Received ECMO bridging to a long-term ventricle assist device or heart transplantation. Infection

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: hemoperfusion<br>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. | Device: hemoperfusion<br>* 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.<br>|
| No Intervention: standard care<br>The patients in the standard care arm will not receive hemoperfusion when lextracorporeal membrane oxygenation (ECMO) is commenced. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of plasma interleukin (IL)-6 level |  | 3 days | 

Secondary Outcome Measures

| Outcome Measure | 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） | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
veno-arterial extracorporeal membrane oxygenation (VA-ECMO), hemoperfusion, inflammatory factor