Stratifying Critically Ill Patients for Novel Ferroptosis or Pyroptosis Intervention Strategies

NCT ID: NCT06928649

Last Updated: 2025-04-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-13
• Study Completion Date: 2026-08-31

Brief Summary

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.

Conditions

Sepsis; Trauma Related Injuries; Subarachnoid Haemorrhage (SAH)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Blood sampling

Intervention Type: 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

Interventions

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

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Urine sampling; Bronchoalveolar lavage sampling; Cerebrospinal fluid sampling

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universiteit Antwerpen

OTHER

Sponsor Role: collaborator

University Hospital, Antwerp

OTHER

Sponsor Role: lead

Responsible Party

Philppe Jorens

Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Philippe Jorens, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Antwerp

Locations

University Hospital Antwerp

Edegem, , Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Tom Stroobants, MD

Role: CONTACT

tom.stroobants@uza.be

+32 3 821 / 24 52

Facility Contacts

Philippe Jorens, MD, PhD

Role: primary

inzo@uza.be

+32 3 821 / 36 35

Other Identifiers

EDGE 3060

Identifier Type: -

Identifier Source: org_study_id