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NCT Number: NCT07206160

Effect of Dapagliflozin on Interleukin 10 in Sepsis

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 64 adult patients of both sex, over the age of 18 years who were admitted to the ICU with sepsis and those who developed sepsis in the ICU.

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.
  • Patients with a history of familial hyperlipidemia. 7. End-stage renal disease (ESRD) on regular dialysis. 8. Type 1 diabetes.

Treatment and study plan

Primary outcomes

  1. the anti-inflammatory effect of dapagliflzin

    Time frame: 7 days

    Effect on inflammatory markers (IL-10).

  2. The anti-inflammatory effect of dapagliflozin in patients with sepsis

    Time frame: baseline

    Effect of dapagliflozin in sepsis evaluated by: Effect on inflammatory markers (IL-10).

Study contacts

Contact information is provided by the study sponsor or research team.

Mostafa Ragab Lokai, Assistant lecturer

CONTACT

[email protected]

201021503446

Sara Mohammed Ali, Assistant professor

CONTACT

201005376176

Sponsors and collaborators

Lead sponsor

Minia University

Other

Registry information

Official study title

Effect of Dapagliflozin on Interleukin 10 Compared to High Density Lipoprotein As a Prognosis in Septic Patients

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 3, 2025
Registry last updated
Oct 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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