Using Polymyxin B to treat septic shock in cardiac surgery patients
Official title: 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
Run by Petrovsky National Research Centre of Surgery · NCT04920565 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Petrovsky National Research Centre of Surgery Academic / other |
| Locations | 1 site (Moscow) |
| Status | Recruiting |
| Started | November 1, 2021 |
| Main results expected | August 31, 2025 |
| Study ends | December 2025 |
| Registry record updated | November 25, 2024 |
| Trial ID | NCT04920565 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adult patients with severe multiple organ dysfunction and high endotoxin activity levels following cardiac surgery.
✕Probably not a fit
Patients with bleeding complications or heparin-induced thrombocytopenia may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While the approach of using polymyxin B in this context is novel, similar studies have shown promise in treating endotoxemia and septic shock.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
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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)
- Email: maxbabaev@mail.ru
- Phone: 89160269066
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.