NCT05726825

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
274

participants targeted

Target at P75+ for not_applicable

Timeline
23mo left

Started Feb 2025

Typical duration for not_applicable

Geographic Reach
3 countries

25 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress40%
Feb 2025Apr 2028

First Submitted

Initial submission to the registry

January 16, 2023

Completed
29 days until next milestone

First Posted

Study publicly available on registry

February 14, 2023

Completed
2 years until next milestone

Study Start

First participant enrolled

February 19, 2025

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2028

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2028

Last Updated

March 13, 2025

Status Verified

March 1, 2025

Enrollment Period

3 years

First QC Date

January 16, 2023

Last Update Submit

March 11, 2025

Conditions

Septic Shock

Keywords

Septic ShockSepsisMulti-organ failureExtracorporeal therapyPlasmapheresis

Outcome Measures

Primary Outcomes (1)

  • 28-day mortality

    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)

    from randomization up to 7 days following randomization

  • Organ support free days until day 28 (KEY secondary outcome)

    from randomization up to 28 days following randomization

  • 90-day mortality

    from randomization up to 90 days following randomization

  • Intensive Care unit (ICU) length of stay

    from randomization until ICU discharge

  • Hospital length of stay

    from randomization until hospital discharge

  • +10 more secondary outcomes

Other Outcomes (1)

  • Safety Endpoints

    from randomization until day 7 following randomization

Study Arms (2)

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.

Device: Therapeutic Plasma Exchange (TPE)

Standard of Care (SOC)

NO INTERVENTION

Non-interventional standard of care

Interventions

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.

Therapeutic Plasma Exchange (TPE)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Age \< 18 or \> 80 years
  • Urogenital focus of infection
  • Pregnancy
  • Heparin-induced thrombocytopenia
  • Known reaction against fresh frozen plasma (FFP)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (25)

University Hospital Innsbruck

Innsbruck, Austria

NOT YET RECRUITING

University Hospital Vienna

Vienna, Austria

NOT YET RECRUITING

St. Joseph Hospital

Berlin, Germany

NOT YET RECRUITING

University Hospital Berlin Charite

Berlin, Germany

NOT YET RECRUITING

University Hospital Bonn

Bonn, 53127, Germany

RECRUITING

Hospital Braunschweig

Braunschweig, Germany

NOT YET RECRUITING

Hospital Bremerhaven

Bremerhaven, Germany

NOT YET RECRUITING

Hospital Cologne Meerheim

Cologne, Germany

NOT YET RECRUITING

University Hospital Cologne

Cologne, Germany

NOT YET RECRUITING

University Hospital Erlangen

Erlangen, Germany

NOT YET RECRUITING

University Hospital Essen

Essen, Germany

NOT YET RECRUITING

University Hospital Halle

Halle, Germany

ACTIVE NOT RECRUITING

University Hospital Hamburg (UKE)

Hamburg, Germany

NOT YET RECRUITING

Hannover Medical School Anesthesiology

Hanover, 30625, Germany

RECRUITING

Hannover Medical School Internal Medicine

Hanover, 30625, Germany

RECRUITING

University Hospital Heidelberg

Heidelberg, 69120, Germany

NOT YET RECRUITING

University Hospital Jena

Jena, Germany

NOT YET RECRUITING

University Hospital Kiel

Kiel, Germany

NOT YET RECRUITING

Hospital Magdeburg

Magdeburg, Germany

NOT YET RECRUITING

University Hospital Munich (TUM) Anesthesiology

Munich, Germany

NOT YET RECRUITING

University Hospital Munich (TUM) Internal Medicine

Munich, Germany

NOT YET RECRUITING

University Hospital Muenster Anesthesiology

Münster, Germany

NOT YET RECRUITING

University Hospital Rostock

Rostock, Germany

NOT YET RECRUITING

University Hospital Bern

Bern, Switzerland

NOT YET RECRUITING

University Hospital Zurich

Zurich, 8091, Switzerland

NOT YET RECRUITING

Related Publications (7)

  • 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.

    PMID: 30373638BACKGROUND

  • 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.

    PMID: 32122366BACKGROUND

  • 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.

    PMID: 33063613BACKGROUND

  • 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.

    PMID: 33471132BACKGROUND

  • 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.

    PMID: 34817751BACKGROUND

  • 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.

    PMID: 35551628BACKGROUND

  • 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.

    PMID: 37061693DERIVED

MeSH Terms

Conditions

Shock, SepticSepsisMultiple Organ Failure

Interventions

Plasma Exchange

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Intervention Hierarchy (Ancestors)

Blood TransfusionBiological TherapyTherapeuticsPlasmapheresisBlood Component RemovalSorption DetoxificationExtracorporeal CirculationSurgical Procedures, Operative

Study Officials

  • Sascha David, Prof. Dr.

    University of Zurich

    PRINCIPAL INVESTIGATOR

  • Klaus Stahl, PD Dr.

    Hannover Medical School

    PRINCIPAL INVESTIGATOR

  • Christian Bode, PD Dr.

    University Hospital, Bonn

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sascha David, Prof. Dr.

CONTACT

+41 44 255 8653sascha.david@usz.ch

Klaus Stahl, PD Dr.

CONTACT

+49 (0)176 1532 8277stahl.klaus@mh-hannover.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2023

First Posted

February 14, 2023

Study Start

February 19, 2025

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

April 1, 2028

Last Updated

March 13, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

AU(2)DE(21)CH(2)