TPE in Septic Patients and Influence on Organ Failure

Multiple Organ Failure Clinical Trial

— TPEMOF  

Official title:

"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"

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02906345
• Other study ID #: A 2016-0144
• Status: Recruiting
• Phase: N/A
• Start date: September 2016
• Est. completion date: August 2022

Study information

• Verified date: April 2020
• Source: University of Rostock
• Contact: Martin Sauer, MD
• Phone: 493814946409
• Email: martin.sauer[@]uni-rostock.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 2022
• Est. primary completion date: April 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Multiple Organ Failure

Intervention

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.

Locations

Country	Name	City	State
Germany	Intensive Care Units PIT 1+2, University Hospital Rostock	Rostock

Sponsors (1)

Lead Sponsor	Collaborator
University of Rostock

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	number of thrombocytes (DIC)	values of thrombocytes, screening for DIC	days 1-7, 14, 21, 28
Other	Haptoglobulin values	values haptoglobulin, screening for hemolysis	days 1-7, 14, 21, 28
Primary	SOFA score = 2 Punkte	SOFA: Sepsis-related Organ Failure Assessment score	day 3
Primary	SOFA score = 2 Punkte	SOFA: Sepsis-related Organ Failure Assessment score	day 7
Secondary	28-day survival	Observation time 28 days	day 28
Secondary	Hospital survival	Leave the patients the hospital?	1 year