"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"
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Multiple Organ Failure
- Sponsor
- University of Rostock
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- SOFA score ≥ 2 Punkte
- Last Updated
- 6 years ago
Overview
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.
Investigators
Dr. Martin Sauer, MD
PD Dr. med. habil.; MD
University of Rostock
Eligibility Criteria
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)
Outcomes
Primary Outcomes
SOFA score ≥ 2 Punkte
Time Frame: day 7
SOFA: Sepsis-related Organ Failure Assessment score
Secondary Outcomes
- 28-day survival(day 28)
- Hospital survival(1 year)