Recruiting

Observational Study

Sponsor:

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Code:

NCT05591924

Conditions

Sepsis

ARDS

Critical Illness

Neurocognitive Dysfunction

Shock, Septic

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Phelebotomy

Broncheoalveolar Lavage

Tracheal Aspirate

Rectal Swab

Study Details

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.

Conditions

Sepsis

ARDS

Critical Illness

Neurocognitive Dysfunction

Shock, Septic

Study ID

NCT05591924

Start date

Apr 26, 2024

Status verified date

Oct, 2025

Completion date

Dec 31, 2034

Anticipated

Primary completion date

Dec 31, 2034

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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)

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

ESTABLISH

Adults over 18 years of age admitted to the ICU within 48 hours and whose presentation to the Emergency Department was within 72h of ICU admission.

Healthy Controls

Adults over 18 years of age with no infectious symptoms, interaction with the health care system, or antimicrobial use in the past 14 days and no history of immunosuppression.

Interventions

Phelebotomy

Collection of 10mL of heparin anticoagulated blood, 10mL of EDTA anticoagulated blood, and 3mL of blood in a PAX gene tube

Broncheoalveolar Lavage

Bronchioalveolar 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

Tracheal 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

A Rectal will be obtained at the time of ICU admission and on all study days during the ICU admission

Primary outcome measure

  • Risk of developing nosocomial infections during ICU admission [ Time Frame: Assessed daily until discharge from ICU, through study completion, an average of 1 year ]
  • Severity of illness measured by APACHE score [ Time Frame: At the time of ICU admission ]
  • Severity of illness measured by SOFA score [ Time Frame: At the time of ICU admission ]
  • Severity of illness measured by MODS score [ Time Frame: At the time of ICU admission ]
  • Change in severity of illness measured by APACHE score [ Time Frame: From the time of ICU admission, assessed daily until death or discharge from ICU, up to 12 months ]
  • Change in severity of illness measured by SOFA score [ Time Frame: From the time of ICU admission, assessed daily until death or discharge from ICU, up to 12 months ]
  • Change in severity of illness measured by MODS score [ Time Frame: From the time of ICU admission, assessed daily until death or discharge from ICU, up to 12 months ]
  • Hospital disposition [ Time Frame: Determined at the time of discharge from the hospital, through study completion, an average of 1 year ]

Central Contacts and Locations

Central contacts

Aleks Leligdowicz, MD PhD

519-661-2111aleligdo@uwo.ca

Locations

Aleks Leligdowicz

Recruiting

London, Ontario, Canada, N6A 3K7

Contacts

Aleks Leligdowicz, MD PhD

519-661-2111aleks.leligdowicz@lhsc.on.ca

More Information

Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Last update posted

Oct 6, 2025

Last verified

Oct, 2025

Keywords

  • Critical Care
  • Sepsis
  • ARDS
  • Inflammation
  • Immune responses
  • Neurocognition
  • Critical illness
  • Translational Biology

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's on 2025-10-06.