Using hemoperfusion to improve outcomes in patients on ECMO for cardiogenic shock

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

This study is testing if adding hemoperfusion to ECMO treatment can help reduce inflammation in patients with cardiogenic shock.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Beijing Anzhen Hospital (other)
• Locations: 1 site (Beijing, Beijing)
• Trial ID: NCT03729765 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of hemoperfusion on patients undergoing veno-arterial extracorporeal membrane oxygenation (VA-ECMO) due to cardiogenic shock. Participants will be randomly assigned to receive either hemoperfusion alongside ECMO or standard care without hemoperfusion. The primary outcome measured will be the change in plasma interleukin-6 levels, an inflammatory marker, after the initiation of hemoperfusion. The goal is to assess whether hemoperfusion can mitigate the inflammatory response associated with ECMO support.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 who are admitted to the ICU with diagnosed cardiogenic shock requiring ECMO support.

Not a fit: Patients with active hemorrhage, severe obesity (BMI≥40), or those who have infections may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved outcomes and reduced complications for patients with cardiogenic shock receiving ECMO.

How similar studies have performed: While the use of hemoperfusion in ECMO patients is a novel approach, similar studies have shown promise in reducing inflammatory responses in critically ill patients.

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

Where this trial is running

Beijing, Beijing

• Center for Cardiac Intensive Care, Beijing Anzhen Hospital, Capital Medical University — Beijing, Beijing, China (RECRUITING)

Study contacts

• Study coordinator: Xiaotong Hou, PhD., Md.

Conditions: Cardiogenic Shock, veno-arterial extracorporeal membrane oxygenation, hemoperfusion, inflammatory factor