Finding early biological signs of severe illness in ICU patients

Prospective Observational Study of Biology of Critical Illness

The study will collect blood, lung, and rectal samples from adults newly admitted to the ICU to see if early biological signs can help diagnose and personalize care for sepsis, ARDS, or other critical illnesses.

Quick facts

• Study type: Observational
• Enrollment: 1000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's (other)
• Locations: 1 site (London, Ontario)
• Trial ID: NCT05591924 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults (≥18) admitted to the ICU within 48 hours who show signs of critical illness such as altered mental status, cardiovascular or respiratory collapse, or suspected severe infection.

Not a fit: Patients under 18, those admitted to the ICU for non-critical reasons (bed‑spacing), or patients admitted more than 72 hours after initial emergency presentation are unlikely to benefit.

Why it matters

Potential benefit: If successful, the findings could enable earlier diagnosis of sepsis and ARDS and help tailor treatments to patients most likely to benefit, potentially reducing ICU morbidity and mortality.

How similar studies have performed: Previous observational cohorts have identified candidate biomarkers and immune patterns in sepsis and ARDS, but translating these findings into routine diagnostics or therapies has been limited, so this work builds on existing but still early evidence.

Eligibility criteria

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 this trial is running

London, Ontario

• Aleks Leligdowicz — London, Ontario, Canada (RECRUITING)

Study contacts

• Principal investigator: Aleks Leligdowicz, MD PhD — Western University
• Study coordinator: Aleks Leligdowicz, MD PhD

Conditions: Sepsis, ARDS, Critical Illness, Neurocognitive Dysfunction, Shock, Septic, Ventilator Associated Pneumonia, Immune Suppression, Inflammation