Randomized Trial Evaluating Therapeutic Plasma Exchange Added to Standard Care for Adults With Early Septic Shock

What this Trial Is About

Septic shock is a life-threatening condition caused by a harmful response to infection that leads to organ failure and high risk of death. This trial is designed to evaluate whether adding therapeutic plasma exchange TPE early in treatment can reduce organ damage and improve outcomes in patients with early septic shock. The study addresses a critical need for more specific treatments beyond current supportive care. Participants will be randomly assigned to receive either one or two sessions of TPE using donor fresh frozen plasma within the first day after randomization or standard care without TPE. The first TPE session occurs within 6 hours and lasts about 2 to 3 hours, with a second session possible if high doses of vasopressors are still needed. Plasma is replaced at a fixed volume ratio to the patients plasma. Anticoagulants like heparin or citrate may be used during TPE. During the study, researchers will monitor participants for 28 days to assess survival, organ function, and need for organ support. They will collect detailed data on organ failure scores, heart and lung function, blood tests, infections, and length of hospital stay. Safety and treatment effects will be closely followed up to 90 days after randomization. The overall study duration varies per patient based on recovery and hospital discharge.

Efficacy of Add-on Plasma Exchange As an Adjunctive Strategy Against Septic Shock