What is empagliflozin studying for sepsis?

Empagliflozin is being studied to see if it can improve clinical outcomes and reduce inflammation in adults with sepsis. Researchers want to learn if adding this drug to standard care can help patients survive and recover better. The trial is sponsored by the Hospital Authority in Hong Kong.

Who may be eligible for this sepsis clinical trial?

Adults aged 18 or older with new onset sepsis admitted to intensive care may be eligible. Both men and women can join if they can take oral medication and provide consent. People with recent use of SGLT2 inhibitors, kidney problems, pregnancy, or unstable conditions are excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this sepsis clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel expenses to attend study visits may vary and are not guaranteed to be covered. Participants can plan accordingly based on their situation.

Actively Recruiting

Phase Not Applicable

Age: 18Years +

All Genders

ID06473844

Study of Safety and Effectiveness of Empagliflozin in Adults With Sepsis in ICUs with Placebo Comparison

Led by Hospital Authority, Hong Kong · Updated on 2025-03-19

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Sepsis is a serious global health issue causing millions of cases and high mortality, especially when organ failure leads to intensive care admission. This research investigates how SGLT2 inhibitors, a class of drugs originally for type 2 diabetes but shown to improve heart and kidney health, may affect clinical outcomes in adults with sepsis. The study aims primarily to assess the safety and effectiveness of these drugs in sepsis patients and secondarily to study their impact on inflammation markers. Adults aged 18 and older with new onset sepsis admitted to intensive care units will be randomly assigned to receive either the SGLT2 inhibitor empagliflozin 10 mg once daily or a placebo tablet daily, alongside standard care until hospital discharge. The trial is double-blind and placebo-controlled, designed to test both clinical outcomes and the feasibility of a larger multicenter study. Participants will be monitored daily during their hospital stay, with blood samples taken to measure inflammatory markers such as interleukins and C-reactive protein at baseline and day 7. Researchers will track primary outcomes including 28-day mortality and changes in organ failure scores, ensuring safety and efficacy data are collected throughout the trial. The study is expected to run until early 2027.

CONDITIONS

Brief Title

Efficacy of SGLT2 Inhibitors in Adults With Sepsis

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Aged 18 years or above
New onset of sepsis within 48 hours defined according to the Sepsis-3 criteria (SOFA score )
Signed and dated informed consent from participant or surrogate
Ability to take and follow oral and enteral medication
Willingness to comply with study procedures

You will not qualify if you...

Current or recent use of SGLT2 inhibitors within 12 weeks before randomization
Impaired renal function
Clinically unstable or in refractory low blood pressure
History of ketoacidosis
Gastrointestinal surgery or absorption disorders
Pregnancy
Known allergy or hypersensitivity to any SGLT2 inhibitors
Use of another investigational drug or intervention within 30 days before trial

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - From recruitment until hospital discharge

Participants receive either the SGLT2 inhibitor empagliflozin 10mg or placebo once daily, in addition to standard care, from recruitment until hospital discharge.

Daily visits until hospital discharge