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

Beijing Anzhen Hospital1 site in 1 country60 target enrollmentOctober 19, 2018

ConditionsCardiogenic Shock

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cardiogenic Shock
Sponsor: Beijing Anzhen Hospital
Enrollment: 60
Locations: 1
Primary Endpoint: change of plasma interleukin (IL)-6 level
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

October 19, 2018

End Date

December 31, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Beijing Anzhen Hospital

Responsible Party

Principal Investigator

Xiaotong Hou

Director of Center for Cardiac Intensive Care

Beijing Anzhen Hospital

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
•Received ECMO bridging to a long-term ventricle assist device or heart transplantation.

Outcomes

Primary Outcomes

change of plasma interleukin (IL)-6 level

Time Frame: 3 days

Secondary Outcomes

Rate of Multiple organ dysfunction syndrome (MODS)(30 days)
All-cause mortality(30 days)
change of other inflammatory factor level(3 days)
Duration on invasive ventilation(60 days)
Hospital length of stay(60 days)
Rate of infection(30 days)
Duration on extracorporeal membrane oxygenation (ECMO) support(60 days)
Rate of successful weaning from extracorporeal membrane oxygenation (ECMO)(30 days)
ICU length of stay(60 days)
Rate of adverse event(30 days)