Effect of Dapagliflozin on Interleukin 10 in Sepsis

NCT07206160 | Not Yet Recruiting

• 1 other identifier: Dapagliflozin in sepsis
• Study Type: observational
• Target: 64
• Locations: 0 countries
• Sites: N/A

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. 1.Severity of sepsis evaluated by the SOFA score.
2. 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. 3.ICU mortality \&hospital length stay.

Conditions

Sepsis

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Group (D) will receive dapagliflozin 10mg tablet and Group (C) will receive vitastress tablet

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Minia University: lead

Related Publications (2)

• 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.

  PMID: 15090974 BACKGROUND

• 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.

  PMID: 26903338 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Mostafa Ragab Lokai, Assistant lecturer

CONTACT

201021503446; ragab63mm@gmail.com

Sara Mohammed Ali, Assistant professor

CONTACT

201005376176

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer of Anesthesia and Intensive Care

Study Record Dates

• First Submitted: September 25, 2025
• First Posted: October 3, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: October 3, 2025

Record last verified: 2025-09