An observational study in Sepsis and Septic Shock, sponsored by Mater Dei Hospital, Malta. Recruiting at 1 site in Malta. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-16.
Sponsored by Mater Dei Hospital, Malta · Observational
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.
1,078 studies on the registry are indexed under Shock, Septic; 232 are open to participants now.
This study's planned enrollment of 460 is above the median of 108 across 406 observational studies indexed under Shock, Septic.
Browse Shock, Septic studies →Mater Dei Hospital, Malta is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Compared within Shock, Septic, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Sepsis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
All-cause sepsis, non-infectious critical illness, and control participants
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Exclusion criteria:
Suspected infection accompanied by organ dysfunction identified as a total SOFA score ≥ 2 points diagnosed within 24 hours after ITU admission. Definition in line with the Sepsis-3 criteria.
Patients admitted to the ITU with non-infectious etiologies, including trauma.
Age-, sex-, and comorbidity-matched participants from the community or long term care facility
Molecular subtype assignments
Molecular subtype classification of sepsis patients using a consensus transcriptomic subtype model
Time frame: Through study completion, an average of 2 year
Molecular information about the host response in patients with sepsis
Measurement of soluble mediators of host immune responses, including inflammation, coagulation, endothelial function
Time frame: Through study completion, an average of 2 year
Survival
Assessment of survival
Time frame: 3 years
Plan to share: No
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Mater Dei Hospital, Malta