Using plasma exchange to treat septic shock
Randomized, Prospective, Multicenter, Open-label, Controlled, Parallel-group Trial Investigating the Efficacy of Add-on Plasma Exchange As an Adjunctive Strategy Against Septic Shock - 2
This study is testing if a treatment called plasma exchange can help people with early septic shock recover better and reduce organ failure.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 274 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Hannover Medical School Academic / other |
| Locations | 25 sites (Innsbruck and 24 other locations) |
| Trial ID | NCT05726825 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a randomized, prospective, multicenter, open-label, controlled, parallel-group intervention aimed at evaluating the effectiveness of therapeutic plasma exchange (TPE) in patients experiencing early septic shock. Sepsis is a critical condition characterized by organ dysfunction due to an overwhelming immune response to infection, leading to high mortality rates. The study hypothesizes that TPE can mitigate the harmful host response by removing detrimental mediators, potentially reducing organ failure and improving patient outcomes. Participants will be closely monitored to assess the impact of this adjunctive treatment on their recovery.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 80 who have newly developed septic shock within the last 24 hours and require vasopressor support.
Not a fit: Patients with urogenital infections, those under 18 or over 80 years old, pregnant women, and individuals with specific contraindications will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve survival rates and reduce organ dysfunction in patients with septic shock.
How similar studies have performed: While innovative approaches to treating septic shock have been limited, this trial explores a novel adjunctive treatment that has not been extensively tested in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * New onset of septic shock (\< 24 hrs), (SEPSIS-3 definition) * Norepinephrine (NE) dose ≥ 0.4 μg/kg/min ≥ 30 min OR NE ≥ 0.3 μg/kg/min + vasopressin (any dose) * Established vascular access suitable for plasma exchange independent of study inclusion (due to established indication of RRT, expected need for RRT within the next 48 hours or other medical reasons as assessed by treating physician team) Exclusion Criteria: * Age \< 18 or \> 80 years * Urogenital focus of infection * Pregnancy * Heparin-induced thrombocytopenia * Known reaction against fresh frozen plasma (FFP)
Where this trial is running
Innsbruck and 24 other locations
- University Hospital Innsbruck — Innsbruck, Austria (Not_yet_recruiting)
- University Hospital Vienna — Vienna, Austria (Not_yet_recruiting)
- St. Joseph Hospital — Berlin, Germany (Not_yet_recruiting)
- University Hospital Berlin Charite — Berlin, Germany (Not_yet_recruiting)
- University Hospital Bonn — Bonn, Germany (Recruiting)
- Hospital Braunschweig — Braunschweig, Germany (Not_yet_recruiting)
- Hospital Bremerhaven — Bremerhaven, Germany (Not_yet_recruiting)
- Hospital Cologne Meerheim — Cologne, Germany (Not_yet_recruiting)
- University Hospital Cologne — Cologne, Germany (Not_yet_recruiting)
- University Hospital Erlangen — Erlangen, Germany (Not_yet_recruiting)
- University Hospital Essen — Essen, Germany (Not_yet_recruiting)
- University Hospital Halle — Halle, Germany (Active_not_recruiting)
- University Hospital Hamburg (UKE) — Hamburg, Germany (Not_yet_recruiting)
- Hannover Medical School Anesthesiology — Hanover, Germany (Recruiting)
- Hannover Medical School Internal Medicine — Hanover, Germany (Recruiting)
- University Hospital Heidelberg — Heidelberg, Germany (Not_yet_recruiting)
- University Hospital Jena — Jena, Germany (Not_yet_recruiting)
- University Hospital Kiel — Kiel, Germany (Not_yet_recruiting)
- Hospital Magdeburg — Magdeburg, Germany (Not_yet_recruiting)
- University Hospital Munich (TUM) Anesthesiology — Munich, Germany (Not_yet_recruiting)
- University Hospital Munich (TUM) Internal Medicine — Munich, Germany (Not_yet_recruiting)
- University Hospital Muenster Anesthesiology — Münster, Germany (Not_yet_recruiting)
- University Hospital Rostock — Rostock, Germany (Not_yet_recruiting)
- University Hospital Bern — Bern, Switzerland (Not_yet_recruiting)
- University Hospital Zurich — Zurich, Switzerland (Not_yet_recruiting)
Study contacts
- Principal investigator: Sascha David, Prof. Dr. — University of Zurich
- Study coordinator: Sascha David, Prof. Dr.
- Email: sascha.david@usz.ch
- Phone: +41 44 255 8653
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.