Clinical Trial: TPE in Septic Patients and Influence on Organ Failure

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary:

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.


Sponsor: University of Rostock

Current Primary Outcome:

  • SOFA score ≥ 2 Punkte [ Time Frame: day 3 ]
    SOFA: Sepsis-related Organ Failure Assessment score
  • SOFA score ≥ 2 Punkte [ Time Frame: day 7 ]
    SOFA: Sepsis-related Organ Failure Assessment score


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 28-day survival [ Time Frame: day 28 ]
    Observation time 28 days
  • Hospital survival [ Time Frame: 1 year ]
    Leave the patients the hospital?


Original Secondary Outcome:

  • 28-day survival [ Time Frame: day 28 ]
    Observation time 28 days
  • Hospital survival [ Time Frame: 1 year ]


Information By: University of Rostock

Dates:
Date Received: September 3, 2016
Date Started: September 2016
Date Completion: April 2019
Last Updated: April 19, 2017
Last Verified: April 2017