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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:
64 Patients fulfilling the criteria for sepsis admitted to ICU will be allocated into 2 groups (32 patients in each group):
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group (D) will receive dapagliflozin 10mg tablet and Group (C) will receive vitastress tablet |
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| Measure | Description | Time Frame |
|---|---|---|
| the anti-inflammatory effect of dapagliflzin | Effect on inflammatory markers (IL-10). | 7 days |
| The anti-inflammatory effect of dapagliflozin in patients with sepsis | Effect of dapagliflozin in sepsis evaluated by: Effect on inflammatory markers (IL-10). | baseline |
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Inclusion Criteria:
Exclusion Criteria:
- 1. Patient's refusal, pregnant and lactating patients. 2. Known allergy or intolerance to dapagliflozin. 3. Unable to receive enteral medication& patients with chronic liver disease. 4. Shock 5. Patients with malabsorption disorders & or receipt of total parenteral nutrition and on treatment with statins.
6. Patients with a history of familial hyperlipidemia. 7. End-stage renal disease (ESRD) on regular dialysis. 8. Type 1 diabetes.
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64 adult patients of both sex, over the age of 18 years who diagnosed with sepsis which meet the criteria: Suspicious/ known infection/ Increase of ≥ 2 SOFA score with elevated white blood cells and C reactive protein and inflammatory markers.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mostafa Ragab Lokai, Assistant lecturer | Contact | 201021503446 | ragab63mm@gmail.com | |
| Sara Mohammed Ali, Assistant professor | Contact | 201005376176 |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15090974 | Result | Dellinger RP, Carlet JM, Masur H, Gerlach H, Calandra T, Cohen J, Gea-Banacloche J, Keh D, Marshall JC, Parker MM, Ramsay G, Zimmerman JL, Vincent JL, Levy MM; Surviving Sepsis Campaign Management Guidelines Committee. Surviving Sepsis Campaign guidelines for management of severe sepsis and septic shock. Crit Care Med. 2004 Mar;32(3):858-73. doi: 10.1097/01.ccm.0000117317.18092.e4. | |
| 26903338 |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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| Result |
| Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |