Heterogeneity in sepsis: new biological evidence with clinical applications.
Aleksandra Leligdowicz, Michael A Matthay
https://pubmed.ncbi.nlm.nih.gov/30850013Actively Recruiting
Age: 18Years +
All Genders
Healthy Volunteers
ID05591924
Prospective Observational Study of Biology of Critical Illness in Adults Early Severe Illness Translational Biology Informatics in Humans
Led by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Updated on 2025-10-06
1000
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
L
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Lead Sponsor
L
London Health Sciences Centre
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the early biological factors in critically ill adults admitted to intensive care units (ICU) with conditions such as sepsis and acute respiratory distress syndrome (ARDS). These serious syndromes often overlap and share injury mechanisms, yet no specific therapies currently exist. This observational study aims to improve early diagnosis, identify patients who might benefit from targeted treatments, and support the discovery of new therapies by studying immune system regulation, host-pathogen interactions, and genetic factors. Participants include adults admitted to the ICU within 48 hours whose emergency department visit was within 72 hours prior. Biological samples such as blood, bronchioalveolar lavage fluid (in ventilated patients), tracheal aspirates, and rectal swabs will be collected at admission and several times during the ICU stay. Data analysis will be conducted in batches to address questions about immune function, microbial composition, biological traits distinguishing sepsis or ARDS, and genetic mechanisms influencing critical illness. During the study, participants will undergo sample collection at multiple time points including days 0, 1, 3, 7, 14, and 21 of ICU admission. Researchers will monitor illness severity using scores like APACHE, SOFA, and MODS, assess hospital outcomes, and follow participants for up to a year to evaluate risks such as nosocomial infections and neurocognitive dysfunction. The study also includes healthy control participants for comparison and tracks physiological outcomes within the first 72 hours of ICU admission.
CONDITIONS
Brief Title
Early Severe Illness TrAnslational BioLogy InformaticS in Humans
Who Can Participate
Age: 18Years +
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- ICU admission within 48 hours
- Presentation to the emergency department within 72 hours prior to ICU admission
- Clinical suspicion of critical illness based on any of the following: altered mental status (GCS < 15), cardiovascular collapse (heart rate > 90, systolic blood pressure < 90, vasopressor use, lactate > 2.0), respiratory collapse (respiratory rate > 20, PaCO2 < 32 mm Hg, supplemental oxygen or ventilation), or suspected severe infection (temperature > 38°C or < 36°C, abnormal white blood cell count, or antibiotic use at ICU admission)
You will not qualify if you...
- Age under 18 years old
- More than 72 hours since ICU admission
- ICU admission occurring more than 72 hours after presentation to the emergency department
- No evidence of critical illness (ICU admission due to bed availability rather than clinical need)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Screening and enrollment occur within 48 hours of ICU admission and within 72 hours of presentation to the Emergency Department
Monitoring
Duration - Up to 21 days during ICU admission
Participants are observed with collection of biological samples including blood, tracheal aspirate, rectal swabs, and bronchioalveolar lavage fluid when clinically indicated, to study immune response and host-pathogen interactions during critical illness.
Samples collected at ICU admission (Day 0) and on Days 1, 3, 7, 14, and 21
Long-term Monitoring
Duration - Up to 12 months after ICU discharge
Participants are followed for clinical outcomes including severity of illness scores, risk of nosocomial infections, hospital disposition, and neurocognitive function after ICU discharge.
Assessments at 1, 6, and 12 months after ICU discharge, with daily assessments during ICU stay up to 12 months for some measures
Trial Site Locations
Total: 1 location
1
Aleks Leligdowicz
London, Ontario, Canada, N6A 3K7
Actively Recruiting
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Research Team
A
Aleks Leligdowicz, MD PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Published Research Related To This Trial
Redefining critical illness.
David M Maslove, Benjamin Tang, Manu Shankar-Hari...
https://pubmed.ncbi.nlm.nih.gov/35715504Functional Transcriptomic Studies of Immune Responses and Endotoxin Tolerance in Early Human Sepsis.
Aleksandra Leligdowicz, Jack Kamm, Katrina Kalantar...
https://pubmed.ncbi.nlm.nih.gov/35066510Risk-stratification of febrile African children at risk of sepsis using sTREM-1 as basis for a rapid triage test.
Aleksandra Leligdowicz, Andrea L Conroy, Michael Hawkes...
https://pubmed.ncbi.nlm.nih.gov/34824252Validation of two multiplex platforms to quantify circulating markers of inflammation and endothelial injury in severe infection.
Aleksandra Leligdowicz, Andrea L Conroy, Michael Hawkes...
https://pubmed.ncbi.nlm.nih.gov/28419100Human pulmonary endothelial cell permeability after exposure to LPS-stimulated leukocyte supernatants derived from patients with early sepsis.
Aleksandra Leligdowicz, Lauren F Chun, Alejandra Jauregui...
https://pubmed.ncbi.nlm.nih.gov/30024307Gaps and opportunities in sepsis translational research.
John C Marshall, Aleksandra Leligdowicz
https://pubmed.ncbi.nlm.nih.gov/36470831A Research Agenda for Precision Medicine in Sepsis and Acute Respiratory Distress Syndrome: An Official American Thoracic Society Research Statement.
Faraaz Ali Shah, Nuala J Meyer, Derek C Angus...
https://pubmed.ncbi.nlm.nih.gov/34652268