Evaluation of the Effect of Metformin on the Clinical Outcome of ICU Patients With Sepsis

FMASU MD146/2023

Sepsis is defined as life-threatening organ dysfunction caused by a dysregulated host response to infection. It is considered a condition that arises when the body's response to an infection injures its own tissues and organs. The pathogenesis of sepsis is very complicated as it involves imbalance in inflammatory response, immune dysfunction, mitochondrial damage, coagulopathy, neuroendocrine immune network abnormalities, endoplasmic reticulum stress, autophagy, and other pathophysiological processes, and leads to organ dysfunction. Inflammatory Imbalance represents the most critical basis of sepsis pathogenesis. Sepsis is associated with many biochemical abnormalities that is correlated with patients' prognosis and risk of mortality including increased levels of lactate, procalcitonin and inflammatory cytokines as TNF alpha. Metformin is an oral anti-diabetic drug from the class of biguanides. It is the first line treatment of diabetes type 2. It is widely used as it has good safety profile, low side effect and cheap cost. Metformin has been reported to have an anti-inflammatory and anti-microbial effect. Some studies have shown that metformin has a beneficial effect in sepsis patients. Our study will be the first prospective controlled randomized trial to assess the clinical outcome of metformin in patients with sepsis.

2023-09-10

2024-06-15

2024-07-10

Recruiting

Early phase I

110

Inclusion Criteria: * Age more than 18 years old. * A diagnosis of sepsis according to the latest Sepsis-3 definition * Estimated GFR \>45 ml/min Exclusion Criteria: * • Immunosuppressed or end stage cancer. * Septic Shock. * Pregnancy and breast feeding. * Patients on metformin, Sodium glucose cotransporters or Gliptins. * End stage hepatic disease. * Contraindications to metformin (chronic respiratory failure, chronic cardiac failure, chronic kidney or liver disease, myocardial infarction within the last month). * Patients with hypersensitivity to metformin.

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2023-09-13