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Recruiting NCT06928649

Stratifying Critically Ill Patients for Novel Ferroptosis or Pyroptosis Intervention Strategies

No phase Interventional Sepsis Trauma Related Injuries Subarachnoid Haemorrhage (SAH)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Blood sampling.
Who it may be relevant to
Registry conditions: Sepsis, Trauma Related Injuries, Subarachnoid Haemorrhage (SAH). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Number of patients with survival after 28 days. [Time frame: 28 days]
Secondary outcome measures (2)
  • Change from baseline concentration of Norepinephrine every day during ICU stay [Time frame: 28 days]
  • Change in SOFA score during ICU stay [Time frame: Change from enrollment to 14 days of ICU stay]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

Belgium · 1 center
  • University Hospital Antwerp — Edegem

Identifiers

NCT: NCT06928649 · EDGE 3060

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗