TPE in Septic Patients and Influence on Organ Failure

NCT ID: NCT02906345

Last Updated: 2020-04-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2022-08-31

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.

Conditions

Multiple Organ Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control Group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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

Group Type: ACTIVE_COMPARATOR

Therapeutic Plasma Exchange (TPE)

Intervention Type: 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.

TPE-Centrifugation

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

Group Type: ACTIVE_COMPARATOR

Therapeutic Plasma Exchange (TPE)

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Rostock

OTHER

Sponsor Role: lead

Responsible Party

Dr. Martin Sauer, MD

PD Dr. med. habil.; MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Intensive Care Units PIT 1+2, University Hospital Rostock

Rostock, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Martin Sauer, MD

Role: CONTACT

martin.sauer@uni-rostock.de

493814946409

Facility Contacts

Martin Sauer, PD Dr.

Role: primary

49 381 4946434

Other Identifiers

A 2016-0144

Identifier Type: -

Identifier Source: org_study_id