Efficacy of Add-on Plasma Exchange As an Adjunctive Strategy Against Septic Shock
NCT ID: NCT05726825
Last Updated: 2025-03-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
274 participants
INTERVENTIONAL
2025-02-19
2028-04-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
Standard of Care (SOC)
Non-interventional standard of care
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* Urogenital focus of infection
* Pregnancy
* Heparin-induced thrombocytopenia
* Known reaction against fresh frozen plasma (FFP)
18 Years
80 Years
ALL
No
Sponsors
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Hannover Medical School
OTHER
Responsible Party
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Principal Investigators
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Sascha David, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
University of Zurich
Klaus Stahl, PD Dr.
Role: PRINCIPAL_INVESTIGATOR
Hannover Medical School
Christian Bode, PD Dr.
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Bonn
Locations
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University Hospital Innsbruck
Innsbruck, , Austria
University Hospital Vienna
Vienna, , Austria
St. Joseph Hospital
Berlin, , Germany
University Hospital Berlin Charite
Berlin, , Germany
University Hospital Bonn
Bonn, , Germany
Hospital Braunschweig
Braunschweig, , Germany
Hospital Bremerhaven
Bremerhaven, , Germany
Hospital Cologne Meerheim
Cologne, , Germany
University Hospital Cologne
Cologne, , Germany
University Hospital Erlangen
Erlangen, , Germany
University Hospital Essen
Essen, , Germany
University Hospital Halle
Halle, , Germany
University Hospital Hamburg (UKE)
Hamburg, , Germany
Hannover Medical School Anesthesiology
Hanover, , Germany
Hannover Medical School Internal Medicine
Hanover, , Germany
University Hospital Heidelberg
Heidelberg, , Germany
University Hospital Jena
Jena, , Germany
University Hospital Kiel
Kiel, , Germany
Hospital Magdeburg
Magdeburg, , Germany
University Hospital Munich (TUM) Anesthesiology
Munich, , Germany
University Hospital Munich (TUM) Internal Medicine
Munich, , Germany
University Hospital Muenster Anesthesiology
Münster, , Germany
University Hospital Rostock
Rostock, , Germany
University Hospital Bern
Bern, , Switzerland
University Hospital Zurich
Zurich, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Michael Joannidis, Prof. Dr.
Role: primary
Peter Schellongowski, Prof. Dr.
Role: primary
Jan T. Kielstein, Prof. Dr.
Role: primary
Stefan Kluge, Prof. Dr.
Role: primary
Tobias Lahmer, PD Dr.
Role: primary
Joerg C. Schefold
Role: primary
References
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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.
Stahl 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.
Stahl 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.
David 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.
Stahl 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.
Stahl 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.
David 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.
Other Identifiers
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EXCHANGE-2
Identifier Type: -
Identifier Source: org_study_id
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