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Efficacy of Add-on Plasma Exchange As an Adjunctive Strategy Against Septic Shock

NCT05726825 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 274

Last updated 2025-03-13

No results posted yet for this study

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.

Conditions

  • Septic Shock

Interventions

DEVICE

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.

Sponsors & Collaborators

  • Hannover Medical School

    lead OTHER

Principal Investigators

  • Sascha David, Prof. Dr. · University of Zurich

  • Klaus Stahl, PD Dr. · Hannover Medical School

  • Christian Bode, PD Dr. · University Hospital, Bonn

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-19
Primary Completion
2028-02-29
Completion
2028-04-30

Countries

  • Austria
  • Germany
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05726825 on ClinicalTrials.gov