TPE in Septic Patients and Influence on Organ Failure

Study Overview
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Brief Summary
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Therapeutic plasma exchange (TPE) should used for patients with septic shock in a controlled, prospective study focusing on the organ functions of the patients.

Detailed Description
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Therapeutic plasma exchange (TPE) should used for patients with septic shock in a controlled, prospective study. Investigators will study three groups: untreated control group; TPE group, plasma separation carried out by filtration; TPE group, plasma separation carried out by centrifugation. All treated patients should treated two (minimal) to five times by TPE, depending on the need of norephinephrine for the therapy. For each session 40 ml/kg body weight plasma should be exchange. Fluid resuscitation will be done with fresh frozen plasma. The study will focusing on the organ functions of the patients, especially liver-, kidney- and nervous function and also displayed in the SOFA score on study days 3 and 7.

Official Title
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Analyses on the Effectiveness and Technical Optimization of Therapeutic Plasma Exchange for Patients With Septic Shock, With Special Emphasis on Influencing the Kidney, Liver and Nervous System Through the Extracorporeal Therapy

Conditions
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Multiple Organ Failure

Intervention / Treatment
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* Device: Therapeutic Plasma Exchange (TPE)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Septic shock, beginning of shock < 24 hours Exclusion Criteria: Participation in an another clinical trial within the last 30 days Participation in this study at an earlier date Simultaneous participation in another clinical trial Pregnancy Unpredictable Bleeding (over 2 erythrocyte concentrates daily) Polyneuropathy (known before the beginning of sepsis)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>Patients with septic shock, no therapeutic plasma exchange, BMC standard treatment | |
| Active Comparator: TPE-Filtration Group<br>Patients with septic shock, therapeutic plasma exchange, plasma separation using a filter (Fresenius MultiFiltrate, Kit 16 MPS P2 dry), BMC standard treatment | Device: Therapeutic Plasma Exchange (TPE)<br>* All treated patients should treated two (minimal) to five times by TPE, depending on the need of norephinephrine for the therapy. For each session 40 ml/kg body weight plasma should be exchange. Fluid resuscitation will be done with fresh frozen plasma.<br>|
| Active Comparator: TPE-Centrifugation<br>Patients with septic shock, therapeutic plasma exchange, plasma separation using a centrifuge (Fresenius COM-TEC, PL1 Erythrozytapherese/Plasmabeutel Set) BMC standard treatment | Device: Therapeutic Plasma Exchange (TPE)<br>* All treated patients should treated two (minimal) to five times by TPE, depending on the need of norephinephrine for the therapy. For each session 40 ml/kg body weight plasma should be exchange. Fluid resuscitation will be done with fresh frozen plasma.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SOFA score ≥ 2 Punkte | SOFA: Sepsis-related Organ Failure Assessment score | day 3 | 
| SOFA score ≥ 2 Punkte | SOFA: Sepsis-related Organ Failure Assessment score | day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 28-day survival | Observation time 28 days | day 28 | 
| Hospital survival | Leave the patients the hospital? | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Septic shock, Fresh frozen plasma