TPE in Septic Patients and Influence on Organ Failure
TPEMOF
"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"
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2016
CompletedFirst Submitted
Initial submission to the registry
September 3, 2016
CompletedFirst Posted
Study publicly available on registry
September 20, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2022
CompletedApril 7, 2020
April 1, 2020
5.6 years
September 3, 2016
April 4, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
28-day survival
day 28
Hospital survival
1 year
Other Outcomes (2)
number of thrombocytes (DIC)
days 1-7, 14, 21, 28
Haptoglobulin values
days 1-7, 14, 21, 28
Study Arms (3)
Control Group
NO INTERVENTIONPatients with septic shock, no therapeutic plasma exchange, BMC standard treatment
TPE-Filtration Group
ACTIVE COMPARATORPatients with septic shock, therapeutic plasma exchange, plasma separation using a filter (Fresenius MultiFiltrate, Kit 16 MPS P2 dry), BMC standard treatment
TPE-Centrifugation
ACTIVE COMPARATORPatients with septic shock, therapeutic plasma exchange, plasma separation using a centrifuge (Fresenius COM-TEC, PL1 Erythrozytapherese/Plasmabeutel Set) BMC standard treatment
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.
Eligibility Criteria
You may qualify if:
- Septic shock, beginning of shock \< 24 hours
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Intensive Care Units PIT 1+2, University Hospital Rostock
Rostock, 18055, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PD Dr. med. habil.; MD
Study Record Dates
First Submitted
September 3, 2016
First Posted
September 20, 2016
Study Start
September 1, 2016
Primary Completion
April 1, 2022
Study Completion
August 1, 2022
Last Updated
April 7, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will not share
No.