Using ECMO to treat severe septic shock with heart issues

ExtraCorporeal Membrane Oxygenation in the Therapy for REfractory Septic Shock With Cardiac Function Under Estimated (ECMO-RESCUE): a Prospective, Multicenter, Non-randomized Cohort Study

This study is testing if using a special heart-lung machine called ECMO can help adults with severe septic shock and heart problems survive better than those who only get standard treatment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 64 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Second Affiliated Hospital of Guangzhou Medical University (Academic / other)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT05184296 on ClinicalTrials.gov

What this trial studies

The ECMO-RESCUE study is a multicenter, non-randomized cohort study that evaluates the effectiveness of VA-ECMO treatment in improving the 30-day survival rate of patients suffering from sepsis-induced refractory cardiogenic shock. Eligible patients, aged 18 to 75, will be enrolled based on specific criteria related to their septic shock condition. Participants can choose to receive ECMO treatment, which will be initiated within 6 hours if accepted. The study compares outcomes between those receiving ECMO and those receiving only conventional therapy.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 diagnosed with septic shock and experiencing severe cardiac impairment.

Not a fit: Patients who do not meet the inclusion criteria or have contraindications for ECMO treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly improve survival rates for patients with severe septic shock and cardiac dysfunction.

How similar studies have performed: Previous studies have shown promising results for ECMO in similar patient populations, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

* Age between 18 and 75 years.
* Patients admitted into ICU and diagnosed as septic shock (sepsis-3.0)13, after adequate fluid resuscitation, high-dose vasoactive drug application \[vasoactive inotropic score (VIS) \> 120\] and conventional therapy together with at least one of the following criteria: (1) sustained hypotension \[mean arterial pressure (MAP) \< 65 mmHg\]; (2) persistent lactacemia (two consecutive values \> 5 mmol/L with at least 30 min interval between samples), with non-decreasing trend on steady doses of inotropes and/or vasopressors; (3) persistent low mixed venous blood oxygen saturation (SvO2) (two consecutive values \< 55% with at least 30 min interval between samples), with non-increasing trend on steady doses of inotropes and/or vasopressors. The above condition lasts more than 5 hours.
* Rapidly deteriorating sepsis-induced myocardial impairment is defined by at least one of the following criteria: (1) rapidly deteriorating ventricular function (LVEF \< 35%); (2) cardiac index (CI) \< 2L/min/m2 (\> 3 hr); (3) emerging refractory arrhythmia.
* Informed consent provided by the patient or person with decisional responsibility.

Exclusion Criteria:

* Cardiac dysfunction caused by other causes is excluded, such as acute myocardial infarction, chronic heart failure, congenital cardiac disease, myocardial effusion, moderate to severe aortic regurgitation, severe aortic coarctation and so on.
* High suspicion of pulmonary embolism, tension pneumothorax or cardiac tamponade as a cause of shock.
* Prolonged cardiac arrest (\> 30 min) before ECMO, or CPR survivors remaining comatose.
* Irreversible condition or meet the inclusion criteria for more than 12 hr.
* Presence of active bleeding or anticoagulant contraindications.
* Peripheral artery disease disabling insertion of outflow cannula to femoral artery.
* Irreversible neurological pathology
* Severe underlying condition with lift expectancy less than 1 year.
* Special population, such as pregnancy, acquired immune deficiency syndrome (AIDS).
* Patient included in another interventional clinical trial.

Where this trial is running

Guangzhou, Guangdong

• Chen Weiyan — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Wei-yan Chen

Conditions Extracorporeal Membrane Oxygenation; Septic Shock; Septic Cardiomyopathy; Cardiogenic Shock; refractory septic shock; septic cardiomyopathy; cardiogenic shock