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NCT Number: NCT06928649

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Antwerp

Edegem, 2650, Belgium

Location status: Recruiting

Location contact

Philippe Jorens, MD, PhD

CONTACT

[email protected]

+32 3 821 / 36 35

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood sampling

Diagnostic Test

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

Primary outcomes

  1. Number of patients with survival after 28 days.

    Time frame: 28 days

    Survival in and after ICU.

Secondary outcomes

  1. Change from baseline concentration of Norepinephrine every day during ICU stay

    Time frame: 28 days

  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Tom Stroobants, MD

CONTACT

[email protected]

+32 3 821 / 24 52

Sponsors and collaborators

Lead sponsor

University Hospital, Antwerp

Other

Collaborators

  • Universiteit Antwerpen

Registry information

Official study title

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

Acronym: ICU-FERRO

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 15, 2025
Registry last updated
Apr 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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