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Assessing the Effects of CytoSorb Hemoperfusion on the Development on Immunoparalysis

NCT04643639 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2022-12-22

No results posted yet for this study

Summary

In this randomized, open-label study, the investigators will assess whether CytoSorb hemoperfusion will prevent or attenuate the development of immunoparalysis in healthy volunteers undergoing repeated experimental endotoxemia.

Conditions

  • Sepsis
  • Immune Deficiency
  • Hemoperfusion
  • Blood Purification

Interventions

DEVICE

CytoSorb hemoperfusion

Subjects will be treated with CytoSorb hemoperfusion (in stand-alone setup) for 6 hours at a flow rate of 250 ml/min during endotoxemia.

Sponsors & Collaborators

  • CytoSorbents Europe GmbH

    collaborator INDUSTRY

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • Peter Pickkers, MD, PhD · Radboud University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-16
Primary Completion
2022-10-19
Completion
2022-10-19
FDA Device
Yes

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

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 NCT04643639 on ClinicalTrials.gov