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 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2024-04-26 with a primary completion date of 2034-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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)
Contact & Investigator
Aleks Leligdowicz, MD PhD
PRINCIPAL INVESTIGATOR
Western University
Frequently Asked Questions
Who can join the NCT05591924 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Sepsis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05591924 currently recruiting?
Yes, NCT05591924 is actively recruiting participants. Contact the research team at aleligdo@uwo.ca for enrollment information.
Where is the NCT05591924 trial being conducted?
This trial is being conducted at London, Canada.
Who is sponsoring the NCT05591924 clinical trial?
NCT05591924 is sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's. The principal investigator is Aleks Leligdowicz, MD PhD at Western University. The trial plans to enroll 1,000 participants.