Hemoperfusion in Extracorporeal Membrane Oxygenation (ECMO) Patients

Cardiogenic Shock Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03729765
• Other study ID #: 2018035X
• Status: Recruiting
• Phase: N/A
• Start date: October 19, 2018
• Est. completion date: December 31, 2023

Study information

• Verified date: November 2023
• Source: Beijing Anzhen Hospital
• Contact: Xiaotong Hou, PhD., Md.
• Phone: 86 18911662932
• Email: xt.hou[@]ccmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2023
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiogenic Shock
• Shock, Cardiogenic

Intervention

Device:
• 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.

Locations

Country	Name	City	State
China	Center for Cardiac Intensive Care, Beijing Anzhen Hospital, Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Anzhen Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change of plasma interleukin (IL)-6 level		3 days
Secondary	change of other inflammatory factor level	plasma interleukin (IL)-1ß?8?10(pg/ml)	3 days
Secondary	change of other inflammatory factor level	tumor necrosis factor a (TNF-a)(fmol/ml)	3 days
Secondary	change of other inflammatory factor level	C-reactive protein (CRP)(mg/dl)	3 days
Secondary	All-cause mortality		30 days
Secondary	Rate of Multiple organ dysfunction syndrome (MODS)		30 days
Secondary	Rate of infection	Any kinds of infection	30 days
Secondary	Duration on extracorporeal membrane oxygenation (ECMO) support		60 days
Secondary	Rate of successful weaning from extracorporeal membrane oxygenation (ECMO)	The circulation doesn't deteriorate in 24 hours since weaning from ECMO	30 days
Secondary	Duration on invasive ventilation		60 days
Secondary	ICU length of stay		60 days
Secondary	Hospital length of stay		60 days
Secondary	Rate of adverse event		30 days