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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.
Therapeutic plasma exchange (TPE) should used for patients with septic shock in a controlled, prospective study.
Investigators will study three groups:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | No Intervention | Patients with septic shock, no therapeutic plasma exchange, BMC standard treatment | |
| TPE-Filtration Group | Active Comparator | Patients with septic shock, therapeutic plasma exchange, plasma separation using a filter (Fresenius MultiFiltrate, Kit 16 MPS P2 dry), BMC standard treatment |
|
| TPE-Centrifugation | Active Comparator | Patients with septic shock, therapeutic plasma exchange, plasma separation using a centrifuge (Fresenius COM-TEC, PL1 Erythrozytapherese/Plasmabeutel Set) BMC standard treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Therapeutic Plasma Exchange (TPE) | Device | 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 28-day survival | Observation time 28 days | day 28 |
| Hospital survival | Leave the patients the hospital? | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| number of thrombocytes (DIC) | values of thrombocytes, screening for DIC | days 1-7, 14, 21, 28 |
| Haptoglobulin values | values haptoglobulin, screening for hemolysis |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Martin Sauer, MD | Contact | 493814946409 | martin.sauer@uni-rostock.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Intensive Care Units PIT 1+2, University Hospital Rostock | Recruiting | Rostock | 18055 | Germany |
No.
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| ID | Term |
|---|---|
| D009102 | Multiple Organ Failure |
| D012772 | Shock, Septic |
| ID | Term |
|---|---|
| D012769 | Shock |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D018805 | Sepsis |
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| ID | Term |
|---|---|
| D010951 | Plasma Exchange |
| ID | Term |
|---|---|
| D001803 | Blood Transfusion |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D010956 | Plasmapheresis |
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|
| days 1-7, 14, 21, 28 |
| D007239 |
| Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D001781 |
| Blood Component Removal |
| D016060 | Sorption Detoxification |
| D005112 | Extracorporeal Circulation |
| D013514 | Surgical Procedures, Operative |