Stratifying Critically Ill Patients for Novel Ferroptosis or Pyroptosis Intervention Strategies

Not Applicable

Recruiting

• Conditions: Sepsis; Trauma Related Injuries; Subarachnoid Haemorrhage (SAH)

• Registration Number: NCT06928649
• Lead Sponsor: University Hospital, Antwerp

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-13
• Status Verified: 2025-03
• Study First Submitted: 2025-03-24
• Study First Submitted QC: 2025-04-07
• Last Update Submitted: 2025-04-07
• Study First Posted: 2025-04-15
• Last Update Posted: 2025-04-15
• Primary Completion: 2026-08
• Study Completion: 2026-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of patients with survival after 28 days.	28 days	Survival in and after ICU.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital Antwerp; 🇧🇪 Edegem, Belgium