Finding early biological signs of severe illness in ICU patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective longitudinal observational cohort (ESTABLISH) enrolling adults within 48 hours of ICU admission and within 72 hours of ED presentation. Researchers will collect serial biosamples including blood, bronchoalveolar lavage or tracheal aspirates, and rectal swabs along with clinical data. Laboratory analyses will include immune profiling, genomics, and other molecular assays combined with informatics to identify early biologic traits linked to critical illness phenotypes and outcomes. No experimental treatments are given; the goal is to map biological heterogeneity to improve future diagnosis and targeted therapies.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥18 years old
* ≤48h since ICU admission
* ICU admission within 72h of presentation to the emergency department (ER)
* Clinical critical illness suspected on the basis of any one of the following:

  1. Altered mental status (GCS\<15)
  2. Cardiovascular collapse (presence of any: Heart rate \>90, systolic blood pressure \<90, presence of vasopressors, lactate \>2.0)
  3. Respiratory collapse (presence of any: respiratory rate \>20, PaCO₂ \<32 mm Hg, supplemental oxygen, invasive or non-invasive ventilation)
  4. Suspected severe infection (presence of any: temperature \>38°C or \<36°C, white blood cell (WBC) count \>12,000/mm³ or \<4,000/mm³, presence of 1 or more antibiotics at the time of ICU admission)

Exclusion Criteria:

* Age \<18 years old
* \>72h since ICU admission
* Admission to ICU in patients \>72h after the presentation to the ER
* No evidence of critical illness (ICU admission due to bed-spacing)

Where it's running

• Aleks Leligdowicz
  London, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Aleks Leligdowicz, MD PhD — Western University
• Study coordinator: Aleks Leligdowicz, MD PhD
• Email: aleligdo@uwo.ca
• Phone: 519-661-2111

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.