What is this study trying to find out about critical illness such as sepsis and ARDS?

This study aims to identify biological factors present early during ICU admission that can help diagnose critical illness syndromes like sepsis and ARDS sooner. Researchers want to understand immune system changes, host-pathogen interactions, and genetic influences to improve diagnosis and treatment. The study is led by the London Health Sciences Centre Research Institute and Lawson Research Institute.

Who may be eligible for this critical illness clinical trial?

Adults aged 18 years or older who have been admitted to the ICU within 48 hours and whose emergency department visit was within 72 hours may be eligible. Participants must show signs of critical illness such as altered mental status, cardiovascular or respiratory issues, or suspected severe infection. People with ICU admission over 72 hours ago or no critical illness are excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this critical illness clinical trial?

Study-related care, including all study procedures and visits, is provided at no cost. However, personal travel and other expenses may vary and are not guaranteed to be covered by the study.

Actively Recruiting

Age: 18Years +

All Genders

Healthy Volunteers

ID05591924

Observational Study of Early Biology and Immune Response in Adults With Critical Illness in the ICU

Led by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Updated on 2025-10-06

1000

Participants Needed

Research Sites

N/A

Total Duration

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)

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