Multiple Organ Failure
Conditions
Keywords
Septic shock, Fresh frozen plasma
Brief summary
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
Therapeutic plasma exchange (TPE) should used for patients with septic shock in a controlled, prospective study. Investigators will study three groups: 1. untreated control group; 2. TPE group, plasma separation carried out by filtration; 3. 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.
Interventions
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.
Sponsors
University of Rostock
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SOFA score ≥ 2 Punkte | day 3 | SOFA: Sepsis-related Organ Failure Assessment score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 28-day survival | day 28 | Observation time 28 days |
| Hospital survival | 1 year | Leave the patients the hospital? |
Other
| Measure | Time frame | Description |
|---|---|---|
| number of thrombocytes (DIC) | days 1-7, 14, 21, 28 | values of thrombocytes, screening for DIC |
| Haptoglobulin values | days 1-7, 14, 21, 28 | values haptoglobulin, screening for hemolysis |
Countries
Germany
Contacts
Primary ContactMartin Sauer, MD
Outcome results
None listed