UnknownNot Applicable

Hemoperfusion in Extracorporeal Membrane Oxygenation (ECMO) Patients

China60 participantsStarted 2018-10-19

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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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
✕. BMI≥40
✕. Received ECMO bridging to a long-term ventricle assist device or heart transplantation.

What they're measuring

change of plasma interleukin (IL)-6 level

Timeframe: 3 days

Trial details

NCT IDNCT03729765

SponsorBeijing Anzhen Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-01-31

Contact for this trial

Xiaotong Hou, PhD., Md.

86 18911662932 xt.hou@ccmu.edu.cn

View on ClinicalTrials.gov More Cardiogenic Shock trials