Using Polymyxin B to treat septic shock in cardiac surgery patients

Evalution of the Efficacy and Safety of Hemoperfusion Use With Polymyxin B un Patients With Severe Endotoxemia With Multiple Organ Dysfunction Syndrome After Complicated Operations With Cardiopulmonary Bypass

This study is testing if a treatment using polymyxin B can help adults with septic shock after heart surgery by lowering harmful toxins and improving their organ function.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Petrovsky National Research Centre of Surgery (Academic / other)
• Locations: 1 site (Moscow)
• Trial ID: NCT04920565 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the efficacy and safety of hemoperfusion with polymyxin B in adult patients experiencing severe endotoxemia following cardiac surgery. It is a single-center, historic, randomized trial where patients are categorized based on their endotoxin activity levels. The study aims to assess the effectiveness of polymyxin B in reducing endotoxin levels and improving organ function, with a focus on personalized treatment approaches for septic shock. Patients will undergo hemoperfusion treatment and will be monitored for safety and efficacy outcomes.

Who should consider this trial

Good fit: Ideal candidates are adult patients with severe multiple organ dysfunction and high endotoxin activity levels following cardiac surgery.

Not a fit: Patients with bleeding complications or heparin-induced thrombocytopenia may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve outcomes for patients suffering from septic shock after cardiac surgery.

How similar studies have performed: While the approach of using polymyxin B in this context is novel, similar studies have shown promise in treating endotoxemia and septic shock.

Eligibility criteria

Inclusion Criteria:

* SOFA +2 points in comparison with the previous assessment; РСТ more than 2 ng / ml; CRP more than 150 ng / ml; norepinephrine infusion; intestinal paresis; positive data of blood culture; ЕАА more than 0,6

Exclusion Criteria:

* bleeding; heparin-induced thrombocytopenia

Where this trial is running

Moscow

• Petrovsky National Reasearch Centre of Surgery — Moscow, Russia (Recruiting)

Study contacts

• Principal investigator: MAXIM BABAEV, D.Sc.(medical) — Petrovsky NRCS
• Study coordinator: MAXIM BABAEV, D.Sc.(medical)

Conditions Multiple Organ Dysfunction With Severe Endotoxemia; test EAA; endotoxemia; hemoperfusion with Polymyxin B; cardiac syrgery