Efficacy and Safety of Sodium-Glucose Cotransporter 2 Inhibitors in Adults With Sepsis: A Feasibility Study for a Multicenter Double-Blind Randomized Placebo-Controlled Trial
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
Goal of this clinical trial is to examine the safety and efficacy of SGLT2 inhibitors on the clinical outcomes in patients with sepsis. Main study outcomes are as follows: (i) Primary objective is to examine the efficacy and safety of SGLT2 inhibitors on clinical outcomes in patients with sepsis. (ii) Secondary objective is to examine the effect of SGLT2 inhibitors on inflammatory markers in patients with sepsis.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Aged 18 years or above
• New onset of sepsis within 48 hours defined according to the Sepsis-3 criteria. (≥2 SOFA)
• Provision of signed and dated informed consent form from participant or surrogate
• Ability to take and adhere to oral and enteral medication regimen
• Willingness to comply
Locations
Other Locations
Hong Kong Special Administrative Region
4/F Main Clinical Block and Trauma Centre, Prince of Wales Hospital, Shatin, New Territories, Hong Kong
NOT_YET_RECRUITING
Hong Kong
Adult Intensive Care Unit, Queen Mary Hospital, 102 Pok Fu Lam Road, Hong Kong
RECRUITING
Hong Kong
The University of Hong Kong
RECRUITING
Hong Kong
Contact Information
Primary
Pauline Yeung Ng, MBBS, FHKCP
pyeungng@hku.hk
39103372
Backup
Calvin Tam, BSN, RN
ct7331@hku.hk
07783323202
Time Frame
Start Date: 2025-03-05
Estimated Completion Date: 2027-02-28
Participants
Target number of participants: 60
Treatments
Experimental: SGLT2 inhibitor empagliflozin
10mg daily from recruitment to hospital discharge
Placebo_comparator: Placebo
1 tablet daily from recruitment to hospital discharge
Related Therapeutic Areas
Sponsors
Leads: Hospital Authority, Hong Kong
Collaborators: Chinese University of Hong Kong