NCT04231994: EXCHANGE

Therapeutic Plasmaexchange in Early Septic Shock

Completed Phase 2 Last updated 10 February 2021

What this trial tests

Phase 2 trial testing TPE in Septic Shock in 40 participants. Completed in 31 August 2020.

Timeline

1 June 2018

Primary endpoint
31 July 2020

31 August 2020

Quick facts

Lead sponsor	Hannover Medical School
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	40
Start date	1 June 2018
Primary completion	31 July 2020
Estimated completion	31 August 2020
Sites	2 locations across Germany

Drugs / interventions tested

• TPE

Conditions studied

• Septic Shock — all drugs for Septic Shock →

Sponsor

Hannover Medical School

Who can join

Adults 18 to 80, any sex, with Septic Shock. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Sepsis is defined by the occurrence of critical organ dysfunction in the context of infection. Unfortunately, its incidence appears to be rising, and the mortality of septic shock remains extraordinary high (\> 60%). Death in sepsis arises from shock and multi organ dysfunction that are - at least in part - triggered by an inadequate response of the host's immune system to the infection. Given the injurious role of 1) this overwhelming immune response and 2) the consumption of protective plasmatic factors (e.g. vWF cleaving proteases, hemostatic factors etc.) while the disease is progressing the investigators hypothesize that early therapeutic plasma exchange (TPE) in the most severely ill individuals might improve hemodynamics, oxygenation and ultimately survival. This therapeutic strategy combines 2 major aspects in 1 procedure: 1. removal of harmful circulating molecules and 2. replacement of protective plasma proteins. The investigators designed the EXCHANGE trial to analyze in a randomized fashion the benefit of TPE as an add-on treatment to state of the art standard sepsis care. Only patients with early septic shock (\< 24 hrs) and high catecholamine doses (norepinephrine \> 0.4 ug/kg body weight/min) will be included. Those in the treatment group will receive 1 TPE within 2 hours following randomization. The primary outcome is norepinephrine dose 6 hrs after randomization. The recruitment period is 2 years and will be performed at the Hannover medical School University hospital in Germany. Secondary endpoints (including organ dysfunction as well as biochemical markers of inflammation and coagulation) will be assessed on day 1-8 and day 28 after TPE.

The investigators hope to demonstrate a potential benefit of an additive treatment approach to improve the outcome of patients suffering from septic shock.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Adjuvant therapeutic plasma exchange in septic shock.
   David S, Bode C, Putensen C, Welte T, et al · · 2021 · cited 51× · PMID 33471132 · DOI 10.1007/s00134-020-06339-1
2. Microbe capture by splenic macrophages triggers sepsis via T cell-death-dependent neutrophil lifespan shortening.
   Ioannou M, Hoving D, Aramburu IV, Temkin MI, et al · · 2022 · cited 36× · PMID 35945238 · DOI 10.1038/s41467-022-32320-1
3. Clinical and biochemical endpoints and predictors of response to plasma exchange in septic shock: results from a randomized controlled trial.
   Stahl K, Wand P, Seeliger B, Wendel-Garcia PD, et al · · 2022 · cited 33× · PMID 35551628 · DOI 10.1186/s13054-022-04003-2
4. Effects of therapeutic plasma exchange on the endothelial glycocalyx in septic shock.
   Stahl K, Hillebrand UC, Kiyan Y, Seeliger B, et al · · 2021 · cited 29× · PMID 34817751 · DOI 10.1186/s40635-021-00417-4
5. The effect of therapeutic plasma exchange on the inflammatory response in septic shock: a secondary analysis of the EXCHANGE-1 trial.
   Sauer A, Stahl K, Seeliger B, Wendel-Garcia PD, et al · · 2025 · cited 6× · PMID 39951217 · DOI 10.1186/s40635-025-00725-z
6. Report On Complete Endpoints and Predictors of Response to Plasma Exchange – Results From a Randomized Controlled Trial in Septic Shock Patients
   Stahl K, Wand P, Seeliger B, Schmidt JJ, et al · · 2021 · DOI 10.21203/rs.3.rs-1034791/v1
7. Effects of Therapeutic Plasma Exchange on the Endothelial Glycocalyx in Septic Shock
   Stahl K, Hillebrand UC, Kiyan Y, Schmidt J, et al · · 2021 · DOI 10.21203/rs.3.rs-150965/v2