Molecular Subtype-Specific Mechanisms and Therapeutic Strategies in Sepsis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Sepsis, Septic Shock. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Malta
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Molecular subtype assignments [Time frame: Through study completion, an average of 2 year]
- Molecular information about the host response in patients with sepsis [Time frame: Through study completion, an average of 2 year]
Secondary outcome measures (1)
- Survival [Time frame: 3 years]
Eligibility criteria
Inclusion criteria
- Age ≥ 18 years
- Consent card signed
Exclusion criteria
- Consent card not signed
- Pregnancy
- Prisoners
- Elective cardiac surgery patients with an uncomplicated stay.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
Malta · 1 center
- Mater Dei hospital, Intensive Therapy Unit — Msida
Identifiers
NCT: NCT06287684 · SINO-MALTA-2024-40; ESICM-22