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Status unknownNCT02906345TPEMOFUpdated Apr 7, 2020

TPE in Septic Patients and Influence on Organ Failure

An interventional study of Therapeutic Plasma Exchange (TPE) in Multiple Organ Failure, sponsored by University of Rostock. Status unknown at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-04-07.

Sponsored by University of Rostock · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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 the 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.

02

Conditions studied

  • Multiple Organ Failure

Keywords

  • Septic shock
  • Fresh frozen plasma
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In context

Multiple Organ Failure

156 studies on the registry are indexed under Multiple Organ Failure; 44 are open to participants now.

This study's planned enrollment of 30 is below the median of 75 across 75 interventional studies indexed under Multiple Organ Failure.

Browse Multiple Organ Failure studies →

Lead sponsor

University of Rostock is the lead sponsor of 46 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Septic shock, beginning of shock \< 24 hours

Exclusion criteria

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)
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
30 participants (estimated)

Study arms

  • No intervention
    Control Group

    Patients with septic shock, no therapeutic plasma exchange, BMC standard treatment

  • Active comparator
    TPE-Filtration Group

    Patients with septic shock, therapeutic plasma exchange, plasma separation using a filter (Fresenius MultiFiltrate, Kit 16 MPS P2 dry), BMC standard treatment

    Device: Therapeutic Plasma Exchange (TPE)

  • Active comparator
    TPE-Centrifugation

    Patients with septic shock, therapeutic plasma exchange, plasma separation using a centrifuge (Fresenius COM-TEC, PL1 Erythrozytapherese/Plasmabeutel Set) BMC standard treatment

    Device: Therapeutic Plasma Exchange (TPE)

Interventions

  • DeviceTherapeutic 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.

06

What researchers measure

Primary outcomes

  1. SOFA score ≥ 2 Punkte

    SOFA: Sepsis-related Organ Failure Assessment score

    Time frame: day 3

  2. SOFA score ≥ 2 Punkte

    SOFA: Sepsis-related Organ Failure Assessment score

    Time frame: day 7

Secondary outcomes

  1. 28-day survival

    Observation time 28 days

    Time frame: day 28

  2. Hospital survival

    Leave the patients the hospital?

    Time frame: 1 year

Other outcomes

  1. number of thrombocytes (DIC)

    values of thrombocytes, screening for DIC

    Time frame: days 1-7, 14, 21, 28

  2. Haptoglobulin values

    values haptoglobulin, screening for hemolysis

    Time frame: days 1-7, 14, 21, 28

07

Study locations

1 of 1 sites recruiting
  • Intensive Care Units PIT 1+2, University Hospital Rostock
    Rostock, 18055, Germany
    • Martin Sauer, PD Dr. · Contact · 49 381 4946434
    Recruiting
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References and documents

Individual participant data

Plan to share: No — No.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 7, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02906345
Lead sponsor
University of Rostock
Responsible party
Dr. Martin Sauer, MD (PD Dr. med. habil.; MD, University of Rostock) — Principal investigator
First posted
Sep 20, 2016
Start date
Sep 2016
Primary completion
Apr 2022 (estimated)
Completion
Aug 2022 (estimated)
Last update
Apr 7, 2020

Study contacts

Martin Sauer, MD
Contact
martin.sauer@uni-rostock.de
493814946409

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

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