Back to resultsTPE in Septic Patients and Influence on Organ Failure (TPEMOF)
Primary Purpose
Multiple Organ Failure
Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Therapeutic Plasma Exchange (TPE)
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Organ Failure focused on measuring Septic shock, Fresh frozen plasma
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)
Sites / Locations
- Intensive Care Units PIT 1+2, University Hospital RostockRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Active Comparator
Active Comparator
Arm Label
Control Group
TPE-Filtration Group
TPE-Centrifugation
Arm Description
Patients with septic shock, no therapeutic plasma exchange, BMC standard treatment
Patients with septic shock, therapeutic plasma exchange, plasma separation using a filter (Fresenius MultiFiltrate, Kit 16 MPS P2 dry), BMC standard treatment
Patients with septic shock, therapeutic plasma exchange, plasma separation using a centrifuge (Fresenius COM-TEC, PL1 Erythrozytapherese/Plasmabeutel Set) BMC standard treatment
Outcomes
Primary Outcome Measures
SOFA score ≥ 2 Punkte
SOFA: Sepsis-related Organ Failure Assessment score
SOFA score ≥ 2 Punkte
SOFA: Sepsis-related Organ Failure Assessment score
Secondary Outcome Measures
28-day survival
Observation time 28 days
Hospital survival
Leave the patients the hospital?
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02906345
Brief Title
TPE in Septic Patients and Influence on Organ Failure
Acronym
TPEMOF
Official Title
"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"
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 2016 (undefined)
Primary Completion Date
April 2022 (Anticipated)
Study Completion Date
August 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rostock
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Organ Failure
Keywords
Septic shock, Fresh frozen plasma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Patients with septic shock, no therapeutic plasma exchange, BMC standard treatment
Arm Title
TPE-Filtration Group
Arm Type
Active Comparator
Arm Description
Patients with septic shock, therapeutic plasma exchange, plasma separation using a filter (Fresenius MultiFiltrate, Kit 16 MPS P2 dry), BMC standard treatment
Arm Title
TPE-Centrifugation
Arm Type
Active Comparator
Arm Description
Patients with septic shock, therapeutic plasma exchange, plasma separation using a centrifuge (Fresenius COM-TEC, PL1 Erythrozytapherese/Plasmabeutel Set) BMC standard treatment
Intervention Type
Device
Intervention Name(s)
Therapeutic Plasma Exchange (TPE)
Intervention Description
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.
Primary Outcome Measure Information:
Title
SOFA score ≥ 2 Punkte
Description
SOFA: Sepsis-related Organ Failure Assessment score
Time Frame
day 3
Title
SOFA score ≥ 2 Punkte
Description
SOFA: Sepsis-related Organ Failure Assessment score
Time Frame
day 7
Secondary Outcome Measure Information:
Title
28-day survival
Description
Observation time 28 days
Time Frame
day 28
Title
Hospital survival
Description
Leave the patients the hospital?
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
number of thrombocytes (DIC)
Description
values of thrombocytes, screening for DIC
Time Frame
days 1-7, 14, 21, 28
Title
Haptoglobulin values
Description
values haptoglobulin, screening for hemolysis
Time Frame
days 1-7, 14, 21, 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Martin Sauer, MD
Phone
493814946409
Email
martin.sauer@uni-rostock.de
Facility Information:
Facility Name
Intensive Care Units PIT 1+2, University Hospital Rostock
City
Rostock
ZIP/Postal Code
18055
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Sauer, PD Dr.
Phone
49 381 4946434
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No.
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TPE in Septic Patients and Influence on Organ Failure
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