Randomized, prospective, multicenter, open-label, controlled, parallel-group trial investigating the efficacy of add-on plasma-exchange as an adjunctive strategy against septic shock - 2 (EXCHANGE-2)

• Applicant: Professor Dr. Sascha David
• Subject Area: Pneumology, Thoracic Surgery ; Anaesthesiology ; Nephrology
• Term: since 2022
• Project identifier: Deutsche Forschungsgemeinschaft (DFG) - Project number 494551625

Sepsis is a life-threatening organ dysfunction due a a pathological host response to an infection. The host response is very complex and so far, we have no specific treatment strategy that targets this hallmark of the syndrome. Therapeutic plasma exchange (TPE) is a technique that combines two approaches in one procedure. Besides the efficient removal of harmful circulating mediators (such as cytokines) it can also replace consumed protective proteins (coagulation factors, anti-permeability factors). The available literature (although mostly uncontrolled) supports the hypothesis that TPE might improve hemodynamics and probably even survival. To analyze these aspects we designed a multicentric randomized controlled clinical trial (mRCT, 22 German centers)) testing the use of TPE in early (onset < 24h) and severe (norepinephrine > 0.4 ug/kg/min) septic shock. The primary outcome of the study is the 28-day mortality and power analysis revealed a total group size of 262 patients. Additionally, we will assess many surrogate secondary endpoints.

• DFG Programme: Clinical Trials
• Co-Investigators: Privatdozent Dr. Christian Bode; Privatdozent Dr. Klaus Stahl