Using plasma exchange to treat septic shock

Is this trial a fit for you?

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 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.

Why it matters

Who can join: the full rules

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 it's running

• University Hospital Bonn
  Bonn, Germany Recruiting
• Hannover Medical School Anesthesiology
  Hanover, Germany Recruiting
• Hannover Medical School Internal Medicine
  Hanover, Germany Recruiting
• University Hospital Innsbruck
  Innsbruck, Austria Not yet recruiting
• University Hospital Vienna
  Vienna, Austria Not yet recruiting
• St. Joseph Hospital
  Berlin, Germany 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Personalized Fluid Resuscitation in the Emergency Department

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• Targeting upper-normal magnesium to see if norepinephrine needs drop in septic shock

  This trial tests whether keeping magnesium levels at the upper end of normal can reduce the amount and duration of norepinephrine needed in adults with septic shock.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.