Stratifying Critically Ill Patients for Novel Ferroptosis or Pyroptosis Intervention Strategies

NCT06928649 | Recruiting DMC

• 1 other identifier: EDGE 3060
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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)

Outcome Measures

Primary Outcomes (1)

• Number of patients with survival after 28 days.

  Survival in and after ICU.

  28 days

Secondary Outcomes (2)

• 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

Study Arms (1)

Critical illness

EXPERIMENTAL

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

Interventions

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

Also known as: Urine sampling, Bronchoalveolar lavage sampling, Cerebrospinal fluid sampling

Critical illness

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Antwerp: lead
• Universiteit Antwerpen: collaborator

Study Sites (1)

University Hospital Antwerp

Edegem, 2650, Belgium

RECRUITING

MeSH Terms

Conditions

Sepsis; Subarachnoid Hemorrhage

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Philippe Jorens, MD, PhD

  University Hospital, Antwerp

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tom Stroobants, MD

CONTACT

+32 3 821 / 24 52; tom.stroobants@uza.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: April 15, 2025
• Study Start: March 13, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 15, 2025

Record last verified: 2025-03

Locations

BE (1)