EXCHANGE-2: investigating the efficacy of add-on plasma exchange as an adjunctive strategy against septic shock-a study protocol for a randomized, prospective, multicenter, open-label, controlled, parallel-group trial

Sepsis is as a life-threatening organ dysfunction caused by a dysregulated host response to an infection. The mortality of sepsis and particular of septic shock is very high. Treatment mostly focuses on infection control but a specific intervention that targets the underlying pathological host respo...

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Bibliographic Details
Published in:Current controlled trials in cardiovascular medicine 2023-04, Vol.24 (1), p.277-277, Article 277
Main Authors: David, Sascha, Bode, Christian, Stahl, Klaus
Format: Article
Language:English
Subjects:
Apheresis
Blood transfusions
Care and treatment
Clinical trials
Diagnosis
Dosage and administration
Extracorporeal therapy
Humans
Mortality
Multicenter Studies as Topic
Multiple Organ Failure - therapy
Norepinephrine
Plasma
Plasma exchange (Therapeutics)
Plasma Exchange - adverse effects
Plasmapheresis
Prospective Studies
Randomized controlled trial
Randomized Controlled Trials as Topic
Sepsis
Septic shock
Shock, Septic - diagnosis
Shock, Septic - therapy
Study Protocol
Testing
Treatment Outcome
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Summary:Sepsis is as a life-threatening organ dysfunction caused by a dysregulated host response to an infection. The mortality of sepsis and particular of septic shock is very high. Treatment mostly focuses on infection control but a specific intervention that targets the underlying pathological host response is lacking to the present time. The investigators hypothesize that early therapeutic plasma exchange (TPE) will dampen the maladaptive host response by removing injurious mediators thereby limiting organ dysfunction and improving survival in patients with septic shock. Although small prospective studies demonstrated rapid hemodynamic stabilization under TPE, no adequately powered randomized clinical trial has investigated hard outcomes. This is a randomized, prospective, multicenter, open-label, controlled, parallel-group interventional trial to test the adjunctive effect of TPE in patients with early septic shock. Patients with a refractory (defined as norepinephrine (NE) ≥ 0.4 μg/kg/min ≥ 30 min OR NE 0.3 μg/kg/min + vasopressin) and early (shock onset 
ISSN:1745-6215
1745-6215
DOI:10.1186/s13063-023-07300-5