Stratifying Critically Ill Patients for Novel Ferroptosis or Pyroptosis Intervention Strategies (ICU-FERRO)

April 7, 2025 updated by: Philppe Jorens, University Hospital, Antwerp

Innovative Cell Death Diagnostics Allowing Stratifying Critically Ill Patients for Novel Ferroptosis or Pyroptosis Intervention Strategies

In order to better determine which therapy is best for patiënts which present with organ falure during the course of their stay in the intesive care unit (ICU) , one has to determine which underlying mechanism is causing this organ falure. We will determine levels of so called "biomarkers" for ferroptosis (a mechan ism of iron-related cell death) in the peripheral blood and biological fluids of criticaly ill patients admitted to the ICU with a catastrrophy (severe infection, trauma ...) . Why ? If it turns out that this ferroptosis plays a role in the ocurrence of organ failure in the critially ill, this will lead to new therapies in the future as drugs become more and more available which can influene this biochemical "pahway". of iron-relatd death.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
      • Edegem, Belgium, 2650
        • Recruiting
        • University Hospital Antwerp
        • Contact:
          • Philippe Jorens, MD, PhD
          • Phone Number: +32 3 821 / 36 35
          • Email: inzo@uza.be

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Admitted to the ICU of UZA
  • Critically ill and predicted to be hospitalised in the ICU for > 48 hours (i.e. mostly patients admitted for sepsis, trauma, haemorrhagic shock, neurological catastrophe … which means at risk to develop mono-or multiple organ failure)
  • With arterial line in place (for blood sampling)

Exclusion Criteria:

  • Refusal of consent by patient or closest relative
  • Postoperative patients after major surgery in whom prolonged ICU stay is not foreseen (i.e. elective cardiac surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Critical illness
Patient who are admitted to the ICU, with a predicted length of stay > 48 hours. Admission due to sepsis, trauma, haemorrhagic shock, neurological catastrophe
Diagnostic test: Blood sampling
Blood sampling: 3 first days of admision, 2 ml of plasma daily Urine, BALF, CSF sampling: 1 day during 3 first days of admission
Other Names:
  • Urine sampling
  • Bronchoalveolar lavage sampling
  • Cerebrospinal fluid sampling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with survival after 28 days.
Time Frame: 28 days
Survival in and after ICU.
28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline concentration of Norepinephrine every day during ICU stay
Time Frame: 28 days
28 days
Change in SOFA score during ICU stay
Time Frame: Change from enrollment to 14 days of ICU stay
SOFA score, with a higher score for more severe organ failure
Change from enrollment to 14 days of ICU stay

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Antwerp

Collaborators

Universiteit Antwerpen

Investigators

  • Principal Investigator: Philippe Jorens, MD, PhD, University Hospital, Antwerp

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 13, 2024

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

March 24, 2025

First Submitted That Met QC Criteria

April 7, 2025

First Posted (Actual)

April 15, 2025

Study Record Updates

Last Update Posted (Actual)

April 15, 2025

Last Update Submitted That Met QC Criteria

April 7, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EDGE 3060

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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