Clinical trial NCT03729765: Hemoperfusion in Extracorporeal Membrane Oxygenation (ECMO) Patients
Official title: A Randomized, Controlled Trial: Hemoperfusion in Extracorporeal Membrane Oxygenation (ECMO) Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiogenic Shock
Keywords: veno-arterial extracorporeal membrane oxygenation (VA-ECMO)
hemoperfusion
inflammatory factor
Lead sponsor: Beijing Anzhen Hospital
Sponsor class: OTHER
First posted: 2018-11-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: change of plasma interleukin (IL)-6 level
timeFrame: 3 days
Secondary outcomes:
measure: change of other inflammatory factor level
timeFrame: 3 days
measure: change of other inflammatory factor level
timeFrame: 3 days
measure: change of other inflammatory factor level
timeFrame: 3 days
measure: All-cause mortality
timeFrame: 30 days
measure: Rate of Multiple organ dysfunction syndrome (MODS)
timeFrame: 30 days
measure: Rate of infection
timeFrame: 30 days
measure: Duration on extracorporeal membrane oxygenation (ECMO) support
timeFrame: 60 days
measure: Rate of successful weaning from extracorporeal membrane oxygenation (ECMO)
timeFrame: 30 days
measure: Duration on invasive ventilation
timeFrame: 60 days
measure: ICU length of stay
timeFrame: 60 days
measure: Hospital length of stay
timeFrame: 60 days
measure: Rate of adverse event
timeFrame: 30 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Center for Cardiac Intensive Care, Beijing Anzhen Hospital, Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing Anzhen Hospital
name: Dannuo Han
role: STUDY_CHAIR
References: