Multiple Organ FailureTPEMOFNCT02906345
TPE in Septic Patients and Influence on Organ Failure
A study testing Therapeutic Plasma Exchange (TPE) in people with Multiple Organ Failure, run by University of Rostock at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Organ Failure
- What is being tested?
- Therapeutic Plasma Exchange (TPE)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2016to Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Septic shock, beginning of shock < 24 hours
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Intensive Care Units PIT 1+2, University Hospital Rostock
Rostock, 18055
Martin Sauer, PD Dr., 49 381 4946434
About this study
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"
Therapeutic plasma exchange (TPE) should used for patients with septic shock in a controlled, prospective study focusing on the organ functions of the patients.
Read the 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.
- Conditions
- Multiple Organ Failure
- Being tested
- Therapeutic Plasma Exchange (TPE)
- Keywords
- Septic shock, Fresh frozen plasma
- Medical subject headings
- Multiple Organ Failure, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Therapeutic Plasma Exchange (TPE) |
| 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 Receives: Device: Therapeutic Plasma Exchange (TPE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
SOFA score ≥ 2 Punkte
SOFA: Sepsis-related Organ Failure Assessment score
Measured: day 3
SOFA score ≥ 2 Punkte
SOFA: Sepsis-related Organ Failure Assessment score
Measured: day 7
Secondary outcomes (2)
28-day survival
Observation time 28 days
Measured: day 28
Hospital survival
Leave the patients the hospital?
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionApr 2022 (estimated)
- Study completionAug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Organ FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rostock
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Martin Sauer, MD, University of Rostock
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02906345
- Sponsor's protocol ID
- A 2016-0144
- Acronym
- TPEMOF
- Status last verified
- Apr 2020
- First submitted
- 3 Sep 2016
- Last updated
- 7 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: No.
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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"
- ClinicalTrials.gov ID
- NCT02906345
- Acronym / sponsor ID
- TPEMOF / A 2016-0144
- Conditions
- Multiple Organ Failure
- Keywords
- Septic shock, Fresh frozen plasma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of RostockUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 20 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Patients with septic shock, no therapeutic plasma exchange, BMC standard treatment |
| TPE-Filtration Group | Active comparator | Device: Therapeutic Plasma Exchange (TPE)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 | Device: Therapeutic Plasma Exchange (TPE)Patients with septic shock, therapeutic plasma exchange, plasma separation using a centrifuge (Fresenius COM-TEC, PL1 Erythrozytapherese/Plasmabeutel Set) BMC standard treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Septic shock, beginning of shock < 24 hours
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic Plasma Exchange (TPE)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. | Device | TPE-Centrifugation, TPE-Filtration Group |
Primary outcome
SOFA score ≥ 2 Punkte
Time frame: day 3
SOFA: Sepsis-related Organ Failure Assessment score
SOFA score ≥ 2 Punkte
Time frame: day 7
SOFA: Sepsis-related Organ Failure Assessment score
2 secondary outcomes
28-day survival
Time frame: day 28
Hospital survival
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2020.
- Individual participant dataSharing planned: No. No.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic Plasma Exchange (TPE) in people with Multiple Organ Failure, run by University of Rostock at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Martin Sauer, MD (493814946409, martin.sauer@uni-rostock.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SOFA score ≥ 2 Punkte (time frame: day 3). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2020.