TPE in Septic Patients and Influence on Organ Failure

Not Applicable

• Conditions: Multiple Organ Failure
• Interventions: Device: Therapeutic Plasma Exchange (TPE)

• Registration Number: NCT02906345
• Lead Sponsor: University of Rostock

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:

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.

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-09-03
• Study First Submitted QC: 2016-09-14
• Study First Posted: 2016-09-20
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-04
• Last Update Posted: 2020-04-07
• Primary Completion: 2022-04
• Study Completion: 2022-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TPE-Centrifugation	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
TPE-Filtration Group	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

Primary Outcome Measures

Name	Time	Method
SOFA score ≥ 2 Punkte	day 7	SOFA: Sepsis-related Organ Failure Assessment score

Secondary Outcome Measures

Name	Time	Method
28-day survival	day 28	Observation time 28 days
Hospital survival	1 year	Leave the patients the hospital?

Trial Locations

Locations (1)

Intensive Care Units PIT 1+2, University Hospital Rostock; 🇩🇪 Rostock, Germany