Sepsis
Conditions
Keywords
Sepsis, fenofibrate, silymarin
Brief summary
Sepsis is a life-threatening condition defined by organ dysfunction resulting from the body's dysregulated response to an infection (1). It begins with widespread inflammation and cellular damage, which quickly escalates into total circulatory failure and the breakdown of essential organ systems, including the lungs, kidneys, digestive tract, and brain. This study aims at evaluating the safety and efficacy of fenofibrate versus silymarin for adult patients with sepsis.
Interventions
DRUGFenofibrate
fenofibrate (145 mg) once daily plus conventional sepsis therapy for 7 days.
DRUGSilymarin
silymarin does ranged between (980 - 1120 mg) daily, in divided doses plus conventional sepsis therapy for 7 days.
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult age ≥18 years old. Both male and female patients. Patients diagnosed with sepsis regardless of its etiology, according to the definitions of the Surviving Sepsis Campaign (SSC)
Exclusion criteria
* Late septic shock at presentation with multiple organ failure. Serious gastrointestinal disease. Preexisting end-stage liver disease. Preexisting end-stage renal disease. Pregnant and breastfeeding women. History of allergy or intolerance to fenofibrate or silymarin. Patients with malignancies. Uncontrolled hemorrhage. Patients on immunosuppressant or biological therapies.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in the measured biological markers (TNF-α, MDA, and IL-10) | after seven days | change in the measured biological markers (TNF-α, MDA, and IL-10) |
Outcome results
None listed