TPE in Septic Patients and Influence on Organ Failure (TPEMOF)

University of Rostock

Status: Unknown

Conditions: Multiple Organ Failure

Treatments: Device: Therapeutic Plasma Exchange (TPE)

Study type: Interventional

Funder types: Other

Identifiers

NCT02906345

A 2016-0144

Details and patient eligibility

About

Therapeutic plasma exchange (TPE) should used for patients with septic shock in a controlled, prospective study focusing on the organ functions of the patients.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 3 patient groups

Control Group

No Intervention group

Description:

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

TPE-Filtration Group

Active Comparator group

Description:

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

Treatment:

Device: Therapeutic Plasma Exchange (TPE)

TPE-Centrifugation

Active Comparator group

Description:

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

Treatment:

Device: Therapeutic Plasma Exchange (TPE)