NCT05591924 Early Severe Illness TrAnslational BioLogy InformaticS in Humans
| NCT ID | NCT05591924 |
| Status | Recruiting |
| Phase | — |
| Sponsor | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's |
| Condition | Sepsis |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2024-04-26 |
| Primary Completion | 2034-12-31 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
Advanced stages of the response to life-threatening infection, severe trauma, or other physiological insults often lead to exhaustion of the homeostatic mechanisms that sustain normal blood pressure and oxygenation. These syndromic presentations often meet the diagnostic criteria of sepsis and/or the acute respiratory distress syndrome (ARDS), the two most common syndromes encountered in the intensive care unit (ICU). Although critical illness syndromes, such as sepsis and ARDS, have separate clinical definitions, they often overlap clinically and share several common injury mechanisms. Moreover, there are no specific therapies for critically ill patients, and as a consequence, approximately 1 in 4 patients admitted to the ICU will not survive. The purpose of this observational study is to identify early patient biologic factors that are present at the time of ICU admission that will help diagnose critical illness syndromes earlier, identify who could benefit most from specific therapies, and enable the discovery of new treatments for syndromes such as sepsis and ARDS.
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)