Hemoperfusion in Extracorporeal Membrane Oxygenation (ECMO) Patients

Not Applicable

Recruiting

• Conditions: Cardiogenic Shock
• Interventions: Device: hemoperfusion

• Registration Number: NCT03729765
• Lead Sponsor: Beijing Anzhen Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-19
• Study First Submitted: 2018-10-30
• Study First Submitted QC: 2018-11-02
• Study First Posted: 2018-11-05
• Primary Completion: 2022-01-31
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-22
• Last Update Posted: 2023-11-24
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
hemoperfusion	hemoperfusion	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.

Primary Outcome Measures

Name	Time	Method
change of plasma interleukin (IL)-6 level	3 days

Secondary Outcome Measures

Name	Time	Method
Rate of Multiple organ dysfunction syndrome (MODS)	30 days
change of other inflammatory factor level	3 days	C-reactive protein (CRP)（mg/dl）
All-cause mortality	30 days
Duration on invasive ventilation	60 days
Hospital length of stay	60 days
Rate of infection	30 days	Any kinds of infection
Duration on extracorporeal membrane oxygenation (ECMO) support	60 days
Rate of successful weaning from extracorporeal membrane oxygenation (ECMO)	30 days	The circulation doesn't deteriorate in 24 hours since weaning from ECMO
ICU length of stay	60 days
Rate of adverse event	30 days

Trial Locations

Locations (1)

Center for Cardiac Intensive Care, Beijing Anzhen Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China