Septic ShockEXCHANGE-2NCT05726825
Efficacy of Add-on Plasma Exchange As an Adjunctive Strategy Against Septic Shock
A study testing Therapeutic Plasma Exchange (TPE) in people with Septic Shock, run by Hannover Medical School at 25 sites in 3 countries.
Trial summary
Randomized, prospective, multicenter, open-label, controlled, parallel-group interventional trial to test the adjunctive effect of therapeutic plasma exchange in patients with early septic shock. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Septic Shock
- What is being tested?
- Therapeutic Plasma Exchange (TPE)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 274 participants
- Where
- 25 sitesin 3 countries
- Study dates
- 19 Feb 2025to Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- New onset of septic shock (< 24 hrs), (SEPSIS-3 definition)
- Norepinephrine (NE) dose ≥ 0.4 μg/kg/min ≥ 30 min OR NE ≥ 0.3 μg/kg/min + vasopressin (any dose)
- Established vascular access suitable for plasma exchange independent of study inclusion (due to established indication of RRT, expected need for RRT within the next 48 hours or other medical reasons as assessed by treating physician team)
Who cannot join
- Age < 18 or > 80 years
- Urogenital focus of infection
- Pregnancy
- Heparin-induced thrombocytopenia
- Known reaction against fresh frozen plasma (FFP)
Trial locations and contacts
25 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
25 sites in 3 countries
Germany21 sites, 20 recruiting
- Not yet recruiting
St. Joseph Hospital
Berlin
Christoph Buettner, Christoph.Buettner@sjk.de
- Not yet recruiting
University Hospital Berlin Charite
Berlin
Philipp Enghard, PD Dr., philipp.enghard@charite.de
- Recruiting
University Hospital Bonn
Bonn, 53127
Christian Bode, PD Dr., +49 (0)228 281 14119, christian.bode@ukbonn.de
- Not yet recruiting
Hospital Braunschweig
Braunschweig
Jan T. Kielstein, Prof. Dr.
- Not yet recruiting
Hospital Bremerhaven
Bremerhaven
Joern Bramstedt, Dr., Joern.Bramstedt@klinikum-bremerhaven.de
- Not yet recruiting
Hospital Cologne Meerheim
Cologne
Achim Joerres, Prof. Dr., joerresa@kliniken-koeln.de
- Not yet recruiting
University Hospital Cologne
Cologne
Matthias Kochanek, Prof. Dr., matthias.kochanek@uk-koeln.de
- Not yet recruiting
University Hospital Erlangen
Erlangen
Carsten Willam, Prof. Dr., Carsten.Willam@uk-erlangen.de
- Not yet recruiting
University Hospital Essen
Essen
Thorsten Brenner, Prof. Dr., Thorsten.Brenner@uk-essen.de
- Active, not recruiting
University Hospital Halle
Halle
- Not yet recruiting
University Hospital Hamburg (UKE)
Hamburg
Stefan Kluge, Prof. Dr.
- Recruiting
Hannover Medical School Anesthesiology
Hanover, 30625
Hans-Joerg Gillmann, Dr., gillmann.hans-joerg@mh-hannover.de
- Recruiting
Hannover Medical School Internal Medicine
Hanover, 30625
Klaus Stahl, PD Dr., +49 (0)176 1532 8277, stahl.klaus@mh-hannover.de
- Not yet recruiting
University Hospital Heidelberg
Heidelberg, 69120
Markus Weigand, Markus.Weigand@med.uni-heidelberg.de
- Not yet recruiting
University Hospital Jena
Jena
Michael Bauer, Prof. Dr., michael.bauer@med.uni-jena.de
- Not yet recruiting
University Hospital Kiel
Kiel
Norbert Weiler, Prof. Dr., norbert.weiler@uksh.de
- Not yet recruiting
Hospital Magdeburg
Magdeburg
Martin Sauer, Prof. Dr., Martin.Sauer@Klinikum-Magdeburg.de
- Not yet recruiting
University Hospital Munich (TUM) Anesthesiology
Munich
Markus Heim, Dr., m.heim@tum.de
- Not yet recruiting
University Hospital Munich (TUM) Internal Medicine
Munich
Tobias Lahmer, PD Dr.
- Not yet recruiting
University Hospital Muenster Anesthesiology
Münster
Alexander Zarbock, Prof. Dr., zarbock@uni-muenster.de
- Not yet recruiting
University Hospital Rostock
Rostock
Steffen Mitzner, Prof. Dr., steffen.mitzner@med.uni-rostock.de
Austria2 sites, 2 recruiting
- Not yet recruiting
University Hospital Innsbruck
Innsbruck
Michael Joannidis, Prof. Dr.
- Not yet recruiting
University Hospital Vienna
Vienna
Peter Schellongowski, Prof. Dr.
Switzerland2 sites, 2 recruiting
- Not yet recruiting
University Hospital Bern
Bern
Joerg C. Schefold
- Not yet recruiting
University Hospital Zurich
Zurich, 8091
Sascha David, Prof. Dr., +41 44 255 8653, sascha.david@usz.ch
About this study
Official title: 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
Randomized, prospective, multicenter, open-label, controlled, parallel-group interventional trial to test the adjunctive effect of therapeutic plasma exchange in patients with early septic shock.
Read the detailed description
Sepsis is defined as a life-threatening organ dysfunction caused by a dysregulated host response to an infection; in septic shock profound circulatory, cellular and metabolic abnormalities are associated with an even higher mortality. Sepsis is a major healthcare problem, affecting millions of individuals around the world each year. Its incidence appears to be rising, and the mortality caused by septic shock in Germany in 2015 remains extraordinarily high (58.8%). It is well known - from the pathophysiological point of view - that these patients do not die from their infection per se but rather from multiple organ failure caused by their own overwhelming host response. This fact is so fundamental that it has been implemented as a key part of the 2016 sepsis definition (SEPSIS-3). Despite tremendous efforts during the last decades, innovative approaches targeting this fundamental hallmark of the disease, thereby reducing organ dysfunction, are lacking. Undoubtedly, there is an unmet need to expand the current standard of care for these patients by a more specific intervention.
The investigators hypothesize that early Therapeutic Plasma Exchange (TPE) in the most severely ill individuals will dampen the injurious maladaptive host response by removing injurious mediators thereby limiting organ dysfunction. The potential impact of this trial is of immense clinical relevance as it evaluates a promising adjunctive treatment option for a patient cohort suffering from an extraordinary high mortality. A positive trial result could truly change the current standard of care (SOC) - that is mostly supportive - of septic shock patients. Of note, there is neither a patent nor a direct commercial interest in such a trial.
- Conditions
- Septic Shock
- Being tested
- Therapeutic Plasma Exchange (TPE)
- Keywords
- Septic Shock, Sepsis, Multi-organ failure, Extracorporeal therapy, Plasmapheresis
- Medical subject headings
- Shock, Septic, Sepsis, Multiple Organ Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic Plasma Exchange (TPE)Device
The TPE treatment will be initiated within 6 hrs after randomization. Duration of TPE treatment is approximately 120-180 minutes. An additional second TPE can be performed if the patient remains vasopressor dependent ≥ 0.4 ug/kg/min after 24 hours following the first TPE procedure.
Both unfractionated heparin (UFH) and citrate may be used as anticoagulant medication.
To ensure treatment comparability between different patients, we will replace plasma in a fixed ratio of 1.2 x the individual patient's total plasma fluid.
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic Plasma Exchange (TPE) | Experimental | 1 x TPE with donor Fresh Frozen Plasma (FFPs) (1.2 x individual plasma volume) within the first 6 hrs after randomization.
A second TPE can be performed if the patient remains vasopressor dependent ≥ 0.4 ug/kg/min within 24 hours after the first intervention. Receives: Device: Therapeutic Plasma Exchange (TPE) |
| Standard of Care (SOC) | No intervention | Non-interventional standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day mortality
Measured: from randomization up to 28 days following randomization
Secondary outcomes (15)
Mean daily Sequential Organ Failure Score (SOFA) score over the first 7 days (KEY secondary outcome)
Per-patient mean daily SOFA score over the first 7 days, ranging from 0-24 points with higher scores indicating more severe organ dysfunction
Measured: from randomization up to 7 days following randomization
Organ support free days until day 28 (KEY secondary outcome)
total days free of invasive ventilation, vasopressors/inotrops and renal replacement therapy (RRT) until day 28
Measured: from randomization up to 28 days following randomization
90-day mortality
Measured: from randomization up to 90 days following randomization
Intensive Care unit (ICU) length of stay
total days in ICU
Measured: from randomization until ICU discharge
Hospital length of stay
total days in hospital
Measured: from randomization until hospital discharge
Basic Hemodynamics
includes: Norepinephrine- [µg/kg/min], Dobutamine [µg/kg/min], Epinephrine- [µg/kg/min] and Vasopressin-dose [U/kg/min], Vasocative-inotropic (VIS) Score with higher scores indicating higher vasopressor/inotropic support, Mean arterial pressure (MAP, [mmHg]), Heart Rate (HR, [1/min]), Central venous pressure (CVP, [mmHg]) and Central-Venous Oxygen Saturation (ScvO2, [%]) at 0 and 12 hrs, d1-7
Measured: at days 1-7 following randomization
Extended Hemodynamics
includes: Cardiac Index (CI, [l/min/m2]), Global End-Diastolic Volume Index (GEDI, [ml/m2]), Sytemic Vascular Resistance Index (SVRI, [dyn*s*cm-5*m2]), Stroke Volume Variation (SVV, [%] ), Extravascular Lung Water Index (ELWI, [ml/kg]) and Pulmonar Vascular Permeability Index (PVPI) at at 0 and 12 hrs, d1-7
Measured: at days 1-7 following randomization
Arterial blood gas analysis
includes: pH, PCO2 [mmHg], HCO3- [mmol], PO2 [mmHg], Lactate [mmol/l] at 0 and 12 hrs, d1-7
Measured: at days 1-7 following randomization
Respiratory function
includes: pO2/FiO2, Tidal Volume (VT, [ml]), Positive End-Exspiratory Pressure (PEEP, [cmH2O]), Peak-Pressure (Ppeak, [cmH2O]), Plateau-Pressure (Pplat, [cmH2O]), Respiratory Rate (RR, [1/min]), Inspiratory Time (Tinsp, [s]), Inspiratory-Flow and End-tidal-CO2 (etCO2, [mmHg]) at 0 and 12 hrs, d1-7
Measured: at days 1-7 following randomization
Renal function
includes: Presence of Acute kindey injury (AKI), AKI stage (KDIGO definition) stage 1-3 with higher stage indicating worse renal function, Need for Renal Replacement Therapy (RRT), Estimated Glomerular Filtration Rate (eGFR following CKD-EPI equation) [ml/min], Fluid intake [ml/d], Urine output [ml/d], Ultrafiltration and Net daily fluid balance [ml/d] at 0 and 12 hrs, d1-7 and at ICU discharge
Measured: at days 1-7 following randomization and at ICU discharge
Liver Function
includes: Bilirubin, Aspartate aminotransferase (AST, [U/l]), Alanine aminotransferase (ALT, [U/l]), Alkaline phosphatase (AP, [U/l]), Gamma-glutamyl transferase (GGT, [U/l]), Cholinesterase (CHE, [kU/l]) and Albumin [g/l] at 0 and 12 hrs, d1-7 and at ICU discharge
Measured: at days 1-7 following randomization and at ICU discharge
Sepsis associated coagulopathy
includes: Differential blood count including schistocytes [%], Fibrinogen [g/l] , D-Dimer [mg/l], International Normalized Ratio (INR), Lactate dehydrogenase (LDH, [U/l]), Antithrombin-III (AT-III, [%]), Protein C [%] and International Society on Thrombosis and Hemostasis- Disseminated Intravscular Coagulation Score (ISTH-DIC, [U/l]) ranging from 0-8 points with higher values indication more severe DIC at 0 and 12 hrs, d1-7, A disintegrin and metalloproteinase with a thrombospondin type 1 motif, member 13 (ADAMTS13, [%]) and von-Willebrand-Factor Antigen (vWF:Ag,[IU/l]) at 0 and 24 hrs
Measured: at days 1-7 following randomization
Inflammatory response
includes: C-reactive protein (CRP, [mg/l]), Procalcitonin (PCT, [ug/l]), Interleukin-6 (IL-6, [ng/ml]), Ferritin [ug/l] and Neutrophil/Lymphocyte ratio at 0 and 12 hrs, d1-7
Measured: at days 1-7 following randomization
Cardiac function
includes: Creatine kinase (CK, [U/l]), Myoglobin [ug/l], Troponin T [ng/l], NT-proBNP [ng/l] at 0 and 12 hrs, d1-7 and at ICU discharge
Measured: at days 1-7 following randomization and at ICU discharge
Secondary infections
includes: incidence and type of secondary infections until ICU and hospital discharge, incidence of viral (HSV, EBV, CMV) reactivation at d7 and d14
Measured: from randomization until hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2023
- Study start19 Feb 2025
- Primary completionFeb 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 274 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sascha David, Prof. Dr., Principal investigator, University of ZurichKlaus Stahl, PD Dr., Principal investigator, Hannover Medical SchoolChristian Bode, PD Dr., Principal investigator, University Hospital, Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05726825
- Sponsor's protocol ID
- EXCHANGE-2
- Acronym
- EXCHANGE-2
- Status last verified
- Mar 2025
- First submitted
- 16 Jan 2023
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Knaup H, Stahl K, Schmidt BMW, Idowu TO, Busch M, Wiesner O, Welte T, Haller H, Kielstein JT, Hoeper MM, David S. Early therapeutic plasma exchange in septic shock: a prospective open-label nonrandomized pilot study focusing on safety, hemodynamics, vascular barrier function, and biologic markers. Crit Care. 2018 Oct 30;22(1):285. doi: 10.1186/s13054-018-2220-9.
PubMed 30373638Stahl K, Schmidt JJ, Seeliger B, Schmidt BMW, Welte T, Haller H, Hoeper MM, Budde U, Bode C, David S. Effect of therapeutic plasma exchange on endothelial activation and coagulation-related parameters in septic shock. Crit Care. 2020 Mar 2;24(1):71. doi: 10.1186/s13054-020-2799-5.
PubMed 32122366Stahl K, Bikker R, Seeliger B, Schmidt JJ, Schenk H, Schmidt BMW, Welte T, Haller H, Hoeper MM, Brand K, David S. Effect of Therapeutic Plasma Exchange on Immunoglobulin Deficiency in Early and Severe Septic Shock. J Intensive Care Med. 2021 Dec;36(12):1491-1497. doi: 10.1177/0885066620965169. Epub 2020 Oct 16.
PubMed 33063613David S, Bode C, Putensen C, Welte T, Stahl K; EXCHANGE study group. Adjuvant therapeutic plasma exchange in septic shock. Intensive Care Med. 2021 Mar;47(3):352-354. doi: 10.1007/s00134-020-06339-1. Epub 2021 Jan 20. No abstract available.
PubMed 33471132Stahl K, Hillebrand UC, Kiyan Y, Seeliger B, Schmidt JJ, Schenk H, Pape T, Schmidt BMW, Welte T, Hoeper MM, Sauer A, Wygrecka M, Bode C, Wedemeyer H, Haller H, David S. Effects of therapeutic plasma exchange on the endothelial glycocalyx in septic shock. Intensive Care Med Exp. 2021 Nov 24;9(1):57. doi: 10.1186/s40635-021-00417-4.
PubMed 34817751Stahl K, Wand P, Seeliger B, Wendel-Garcia PD, Schmidt JJ, Schmidt BMW, Sauer A, Lehmann F, Budde U, Busch M, Wiesner O, Welte T, Haller H, Wedemeyer H, Putensen C, Hoeper MM, Bode C, David S. Clinical and biochemical endpoints and predictors of response to plasma exchange in septic shock: results from a randomized controlled trial. Crit Care. 2022 May 12;26(1):134. doi: 10.1186/s13054-022-04003-2.
PubMed 35551628David S, Bode C, Stahl K; EXCHANGE-2 Study group. 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. Trials. 2023 Apr 15;24(1):277. doi: 10.1186/s13063-023-07300-5.
PubMed 37061693
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05726825
- Acronym / sponsor ID
- EXCHANGE-2 / EXCHANGE-2
- Conditions
- Septic Shock
- Keywords
- Septic Shock, Sepsis, Multi-organ failure, Extracorporeal therapy, Plasmapheresis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 274 participants (estimated)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Study start
- 19 Feb 2025 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 14 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized, prospective, multicenter, open-label, controlled, parallel-group interventional trial to test the adjunctive effect of therapeutic plasma exchange in patients with early septic shock.
Detailed description
Sepsis is defined as a life-threatening organ dysfunction caused by a dysregulated host response to an infection; in septic shock profound circulatory, cellular and metabolic abnormalities are associated with an even higher mortality. Sepsis is a major healthcare problem, affecting millions of individuals around the world each year. Its incidence appears to be rising, and the mortality caused by septic shock in Germany in 2015 remains extraordinarily high (58.8%). It is well known - from the pathophysiological point of view - that these patients do not die from their infection per se but rather from multiple organ failure caused by their own overwhelming host response. This fact is so fundamental that it has been implemented as a key part of the 2016 sepsis definition (SEPSIS-3). Despite tremendous efforts during the last decades, innovative approaches targeting this fundamental hallmark of the disease, thereby reducing organ dysfunction, are lacking. Undoubtedly, there is an unmet need to expand the current standard of care for these patients by a more specific intervention.
The investigators hypothesize that early Therapeutic Plasma Exchange (TPE) in the most severely ill individuals will dampen the injurious maladaptive host response by removing injurious mediators thereby limiting organ dysfunction. The potential impact of this trial is of immense clinical relevance as it evaluates a promising adjunctive treatment option for a patient cohort suffering from an extraordinary high mortality. A positive trial result could truly change the current standard of care (SOC) - that is mostly supportive - of septic shock patients. Of note, there is neither a patent nor a direct commercial interest in such a trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therapeutic Plasma Exchange (TPE) | Experimental | Device: Therapeutic Plasma Exchange (TPE)1 x TPE with donor Fresh Frozen Plasma (FFPs) (1.2 x individual plasma volume) within the first 6 hrs after randomization. A second TPE can be performed if the patient remains vasopressor dependent ≥ 0.4 ug/kg/min within 24 hours after the first intervention. |
| Standard of Care (SOC) | No intervention | –Non-interventional standard of care |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- New onset of septic shock (< 24 hrs), (SEPSIS-3 definition)
- Norepinephrine (NE) dose ≥ 0.4 μg/kg/min ≥ 30 min OR NE ≥ 0.3 μg/kg/min + vasopressin (any dose)
- Established vascular access suitable for plasma exchange independent of study inclusion (due to established indication of RRT, expected need for RRT within the next 48 hours or other medical reasons as assessed by treating physician team)
Key exclusion criteria (5 listed)
- Age < 18 or > 80 years
- Urogenital focus of infection
- Pregnancy
- Heparin-induced thrombocytopenia
- Known reaction against fresh frozen plasma (FFP)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic Plasma Exchange (TPE)The TPE treatment will be initiated within 6 hrs after randomization. Duration of TPE treatment is approximately 120-180 minutes. An additional second TPE can be performed if the patient remains vasopressor dependent ≥ 0.4 ug/kg/min after 24 hours following the first TPE procedure. Both unfractionated heparin (UFH) and citrate may be used as anticoagulant medication. To ensure treatment comparability between different patients, we will replace plasma in a fixed ratio of 1.2 x the individual patient's total plasma fluid. | Device | Therapeutic Plasma Exchange (TPE) |
Primary outcome
28-day mortality
Time frame: from randomization up to 28 days following randomization
15 secondary outcomes
Mean daily Sequential Organ Failure Score (SOFA) score over the first 7 days (KEY secondary outcome)
Time frame: from randomization up to 7 days following randomization
Organ support free days until day 28 (KEY secondary outcome)
Time frame: from randomization up to 28 days following randomization
90-day mortality
Time frame: from randomization up to 90 days following randomization
Intensive Care unit (ICU) length of stay
Time frame: from randomization until ICU discharge
Hospital length of stay
Time frame: from randomization until hospital discharge
Basic Hemodynamics
Time frame: at days 1-7 following randomization
Extended Hemodynamics
Time frame: at days 1-7 following randomization
Arterial blood gas analysis
Time frame: at days 1-7 following randomization
Respiratory function
Time frame: at days 1-7 following randomization
Renal function
Time frame: at days 1-7 following randomization and at ICU discharge
Liver Function
Time frame: at days 1-7 following randomization and at ICU discharge
Sepsis associated coagulopathy
Time frame: at days 1-7 following randomization
Inflammatory response
Time frame: at days 1-7 following randomization
Cardiac function
Time frame: at days 1-7 following randomization and at ICU discharge
Secondary infections
Time frame: from randomization until hospital discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Background: PubMed 30373638Knaup H, Stahl K, Schmidt BMW, Idowu TO, Busch M, Wiesner O, Welte T, Haller H, Kielstein JT, Hoeper MM, David S. Early therapeutic plasma exchange in septic shock: a prospective open-label nonrandomized pilot study focusing on safety, hemodynamics, vascular barrier function, and biologic markers. Crit Care. 2018 Oct 30;22(1):285. doi: 10.1186/s13054-018-2220-9.
- Background: PubMed 32122366Stahl K, Schmidt JJ, Seeliger B, Schmidt BMW, Welte T, Haller H, Hoeper MM, Budde U, Bode C, David S. Effect of therapeutic plasma exchange on endothelial activation and coagulation-related parameters in septic shock. Crit Care. 2020 Mar 2;24(1):71. doi: 10.1186/s13054-020-2799-5.
- Background: PubMed 33063613Stahl K, Bikker R, Seeliger B, Schmidt JJ, Schenk H, Schmidt BMW, Welte T, Haller H, Hoeper MM, Brand K, David S. Effect of Therapeutic Plasma Exchange on Immunoglobulin Deficiency in Early and Severe Septic Shock. J Intensive Care Med. 2021 Dec;36(12):1491-1497. doi: 10.1177/0885066620965169. Epub 2020 Oct 16.
- Background: PubMed 33471132David S, Bode C, Putensen C, Welte T, Stahl K; EXCHANGE study group. Adjuvant therapeutic plasma exchange in septic shock. Intensive Care Med. 2021 Mar;47(3):352-354. doi: 10.1007/s00134-020-06339-1. Epub 2021 Jan 20. No abstract available.
- Background: PubMed 34817751Stahl K, Hillebrand UC, Kiyan Y, Seeliger B, Schmidt JJ, Schenk H, Pape T, Schmidt BMW, Welte T, Hoeper MM, Sauer A, Wygrecka M, Bode C, Wedemeyer H, Haller H, David S. Effects of therapeutic plasma exchange on the endothelial glycocalyx in septic shock. Intensive Care Med Exp. 2021 Nov 24;9(1):57. doi: 10.1186/s40635-021-00417-4.
- Background: PubMed 35551628Stahl K, Wand P, Seeliger B, Wendel-Garcia PD, Schmidt JJ, Schmidt BMW, Sauer A, Lehmann F, Budde U, Busch M, Wiesner O, Welte T, Haller H, Wedemeyer H, Putensen C, Hoeper MM, Bode C, David S. Clinical and biochemical endpoints and predictors of response to plasma exchange in septic shock: results from a randomized controlled trial. Crit Care. 2022 May 12;26(1):134. doi: 10.1186/s13054-022-04003-2.
- Derived from this study: PubMed 37061693David S, Bode C, Stahl K; EXCHANGE-2 Study group. 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. Trials. 2023 Apr 15;24(1):277. doi: 10.1186/s13063-023-07300-5.
- Individual participant dataSharing planned: No
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Sepsis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sascha David, Prof. Dr. principal investigator
University of Zurich
Klaus Stahl, PD Dr. principal investigator
Hannover Medical School
Christian Bode, PD Dr. principal investigator
University Hospital, Bonn
25 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic Plasma Exchange (TPE) in people with Septic Shock, run by Hannover Medical School at 25 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Germany, Austria, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sascha David, Prof. Dr. (+41 44 255 8653, sascha.david@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28-day mortality (time frame: from randomization up to 28 days following randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05726825, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.