Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-25 @ 2:16 AM
NCT ID:
NCT07206160
Brief Summary:
The goal of this observational study is to learn about the long-term effects of dapagliflozin as anti-inflammatory agents to improve organ dysfunction and decrease mortality on patients of both genders ageing 18 years or above with sepsis.
1ry Outcome: The anti-inflammatory effect of dapagliflozin in patients with sepsis evaluated by: Effect on inflammatory markers (IL-10).
2ry Outcomes:
1. Severity of sepsis evaluated by the SOFA score.
2. Prognostic value of HDL compared to IL-10 for multi organ failure and death in septic patients and their correlation to the severity of sepsis.
3. ICU mortality \&hospital length stay.
Detailed Description:
64 Patients fulfilling the criteria for sepsis admitted to ICU will be allocated into 2 groups (32 patients in each group):
* Dapagliflozin group: Patients will receive dapagliflozin at a dosage of 10mg mixed with 10ml water at the time of admission for 7 days (or until ICU discharge, whichever comes first).
* Placebo group: Patients will receive vitastress tab .
The solutions of the study medications will be prepared by a hospital pharmacist and the medication will be administrated through the nasogastric tube in patients with disorder of consciousness or swallowing deficit.
Dapagliflozin will be stopped if the patients enter in more than one episode of severe hypoglycemia (≤50mg/dL) or occurrence of euglycemic diabetic ketoacidosis, defined by high anion gap metabolic acidosis and ketone bodies in the urine. Also the drug will be withheld if idiosyncratic drug reactions, such as DRESS syndrome (drug rash with eosinophilia and systemic symptoms) or allergic reaction to dapagliflozin has been occurred and if there is any need for absolute fasting and/or inability to access the enteral route for the drug.
Study:
NCT07206160
Study Brief:
Protocol Section:
NCT07206160