NCT02906345

TPE in Septic Patients and Influence on Organ Failure

"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"

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University of Rostock · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-09-01
• Primary completion: 2022-04-01
• Completion: 2022-08-01
• First posted: 2016-09-20
• Last updated: 2020-04-07

Locations

1 site across 1 country: Germany