About this trial
Sepsis is a complex syndrome that causes lethal organ dysfunction due to an abnormal host response to infection. No drug specifically targeting sepsis has been approved. The heterogeneity in sepsis pathophysiology hinders the identification of patients who would benefit, or be harmed, from specific therapeutic interventions. Recent clinical genomics studies have shown that sepsis patients can be stratified as molecular subtypes, or subclasses, with clinical implications. Classifying sepsis patients as molecular subtypes revealed that a poor prognosis subtype was characterized by immunosuppression and septic shock. Therefore, it has become essential to identify patients who may benefit from or be adversely affected by specific treatments, thereby identifying bona fide treatable traits or endotypes. The goal of this study is to assist the physician at the bedside in tailoring the treatment of an individual patient suffering from sepsis by generating rapid molecular information about immune status.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age ≥ 18 years
Consent card signed
Disqualifiers
Consent card not signed
Pregnancy
Prisoners
Elective cardiac surgery patients with an uncomplicated stay.
Trial population
All-cause sepsis, non-infectious critical illness, and control participants
Trial design
Case-control
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Molecular subtype assignments
Molecular subtype classification of sepsis patients using a consensus transcriptomic subtype model
Molecular information about the host response in patients with sepsis
Measurement of soluble mediators of host immune responses, including inflammation, coagulation, endothelial function
Secondary outcomes
Survival
Assessment of survival
Sponsors and contacts
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Mater Dei Hospital, Malta
Lead sponsor
University of Malta
Collaborator