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

"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.

Study Overview

• Status: Unknown
• Conditions: Multiple Organ Failure
• Intervention / Treatment: Device: Therapeutic Plasma Exchange (TPE)

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Martin Sauer, MD; Phone Number: 493814946409; Email: martin.sauer@uni-rostock.de

Study Locations

• Germany
  • Rostock, Germany, 18055
    • Recruiting
    • Intensive Care Units PIT 1+2, University hospital Rostock

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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); 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.
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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SOFA score ≥ 2 Punkte	SOFA: Sepsis-related Organ Failure Assessment score	day 3
SOFA score ≥ 2 Punkte	SOFA: Sepsis-related Organ Failure Assessment score	day 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
28-day survival	Observation time 28 days	day 28
Hospital survival	Leave the patients the hospital?	1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of thrombocytes (DIC)	values of thrombocytes, screening for DIC	days 1-7, 14, 21, 28
Haptoglobulin values	values haptoglobulin, screening for hemolysis	days 1-7, 14, 21, 28

Collaborators and Investigators

• Sponsor: University of Rostock

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Anticipated): April 1, 2022
• Study Completion (Anticipated): August 1, 2022

Study Registration Dates

• First Submitted: September 3, 2016
• First Submitted That Met QC Criteria: September 14, 2016
• First Posted (Estimate): September 20, 2016

Study Record Updates

• Last Update Posted (Actual): April 7, 2020
• Last Update Submitted That Met QC Criteria: April 4, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Septic shock; Fresh frozen plasma
• Additional Relevant MeSH Terms: Pathologic Processes; Shock; Multiple Organ Failure
• Other Study ID Numbers: A 2016-0144

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No.