Early Severe Illness TrAnslational BioLogy InformaticS in Humans

RecruitingOBSERVATIONAL
Enrollment

1,000

Participants

Timeline

Start Date

April 26, 2024

Primary Completion Date

December 31, 2034

Study Completion Date

December 31, 2034

Conditions
SepsisARDSCritical IllnessNeurocognitive DysfunctionShock, SepticVentilator Associated PneumoniaImmune SuppressionInflammationSIRS
Interventions
PROCEDURE

Phelebotomy

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

PROCEDURE

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.

PROCEDURE

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.

PROCEDURE

Rectal Swab

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

Trial Locations (1)

N6A 3K7

RECRUITING

Aleks Leligdowicz, London

Sponsors
All Listed Sponsors
collaborator

London Health Sciences Centre

OTHER

collaborator

Western University, Canada

OTHER

collaborator

Western University

OTHER

lead

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

OTHER