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.
Age ≥18 years old
≤48h since ICU admission
ICU admission within 72h of presentation to the emergency department (ER)
Altered mental status (GCS<15)
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)
Critically ill adults with early critical illness
Cohort
Prospective
Phelebotomy
Procedure/SurgeryCollection of 10mL of heparin anticoagulated blood, 10mL of EDTA anticoagulated blood, and 3mL of blood in a PAX gene tube
Broncheoalveolar Lavage
Procedure/SurgeryBronchioalveolar lavage fluid (BALF) samples will be obtained from participants who are mechanically ventilated, and a bronchoscopy is indicated as part of routine clinical care. The BALF will be collected by a qualified ICU physician using standard clinical practice. Briefly, patients will receive appropriate sedation and analgesia, a flexible video-bronchoscope will be inserted into the patient's airway, and bronchial segments will be identified. The bronchoscope will be wedged in the most appropriate lung segment and 40-100mL of sterile normal saline (NS) as clinically indicated, will be injected into the bronchoscope port with using a 50mL syringe. Next, the instilled NS (i.e.: lavage fluid) will be collected in a sterile container using gentle suction. The BALF will then be partitioned and sent to clinical laboratories, and the remaining BALF (10-20mL) will be used in the ESTABLISH research study.
Tracheal Aspirate
Procedure/SurgeryTracheal Aspirate (TA) will be obtained from participants who have an endotracheal tube or a tracheostomy in situ at the time of ICU admission through out the ICU admission on the study days, as long as distal airway access is available.
Rectal Swab
Procedure/SurgeryA Rectal will be obtained at the time of ICU admission and on all study days during the ICU admission
Risk of developing nosocomial infections during ICU admission
Development of any of the following: Ventilator Associated Pneumonia, Central Line Infections, Clostridium difficile-Associated Diarrhea, Blood stream infections
Severity of illness measured by APACHE score
APACHE
Severity of illness measured by SOFA score
SOFA
Severity of illness measured by MODS score
MODS
Neurocognitive dysfunction
Cambridge Brain Sciences (CBS) web-based neurocognitive battery
Physiological outcomes
Ultrasound-identified volume responsiveness
Click on the lead sponsor to view all of their trials.
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Lead sponsor
London Health Sciences Centre
Collaborator
Western University, Canada
Collaborator
Western University
Collaborator
