Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-25 @ 2:00 AM
NCT ID:
NCT06683794
Eligibility Criteria:
Inclusion Criteria:
* Adults patients admitted to the ICU with a diagnosis of sepsis or septic shock according to the Surviving Sepsis Campaign criteria. Diagnostic Criteria for Sepsis and Septic Shock (Sepsis-3) Sepsis: Life-threatening organ dysfunction caused by a dysregulated host response to infection. Organ dysfunction is identified as an acute change in total SOFA (Sequential organ failure assessment) score ≥2 points due to infection.
Septic Shock: A subset of sepsis where underlying circulatory and cellular/metabolic abnormalities are profound enough to substantially increase mortality. Patients with septic shock can be clinically identified by a vasopressor requirement to maintain a mean arterial pressure (MAP) of 65 mm Hg or greater and a serum lactate level \>2 mmol/L in the absence of hypovolemia.
Exclusion Criteria:Patients with pre-existing liver disease e.g. chronic hepatitis or cirrhosis.
2\. Patients with a history of alcohol abuse. 3. Patients on high dose statin therapy. 4. patients with other causes that could raise AST and ALT e,g, rhabdomyolysis, myocardial infarction.
4\. Patients with missed data or who couldnt be followed up
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Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06683794
Study Brief:
Protocol Section:
NCT06683794