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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Center for Cardiac Intensive Care, Beijing Anzhen Hospital, Capital Medical University
RECRUITING
Beijing
Contact Information
Primary
Xiaotong Hou, PhD., Md.
xt.hou@ccmu.edu.cn
86 18911662932
Backup
Dannuo Han
handannuo@163.com
13720055429
Time Frame
Start Date: 2018-10-19
Estimated Completion Date: 2023-12-31
Participants
Target number of participants: 60
Treatments
Experimental: 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.
No_intervention: standard care
The patients in the standard care arm will not receive hemoperfusion when lextracorporeal membrane oxygenation (ECMO) is commenced.
Related Therapeutic Areas
Sponsors
Leads: Beijing Anzhen Hospital

This content was sourced from clinicaltrials.gov