Testing SGLT2 inhibitors for treating sepsis in adults
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
This study is testing if a new type of diabetes medication can help adults with sepsis recover better and feel safer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital Authority, Hong Kong Government |
| Locations | 3 sites (Hong Kong, Hong Kong and 2 other locations) |
| Trial ID | NCT06473844 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety and efficacy of SGLT2 inhibitors in improving clinical outcomes for adults diagnosed with sepsis. The primary objective is to assess how these medications affect patients' recovery and safety, while the secondary objective focuses on their impact on inflammatory markers associated with sepsis. Given the high mortality rates linked to sepsis and the limited effective treatments available, this trial seeks to explore a novel therapeutic option that may address this urgent medical need.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 years or older who have experienced new onset of sepsis within the last 48 hours.
Not a fit: Patients with impaired renal function, those currently using SGLT2 inhibitors, or those with a history of ketoacidosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve recovery rates and reduce mortality in patients suffering from sepsis.
How similar studies have performed: While other studies have explored various treatments for sepsis, the use of SGLT2 inhibitors in this context is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Current or recent use of SGLT2 inhibitors (within 12wks prior to randomization) * Impaired renal function * Clinically unstable or in refractory hypotension * History of ketoacidosis * Gastrointestinal surgery or GI absorption / malabsorption disorder * Pregnancy * Known allergic or hypersensitivity reactions to any SGLT2 inhibitors * Treatment with another investigational drug or other interventions within 30 days prior to trial
Where this trial is running
Hong Kong, Hong Kong and 2 other locations
- 4/F Main Clinical Block and Trauma Centre, Prince of Wales Hospital, Shatin, New Territories, Hong Kong — Hong Kong, Hong Kong, Hong Kong (Not_yet_recruiting)
- Adult Intensive Care Unit, Queen Mary Hospital, 102 Pok Fu Lam Road, Hong Kong — Hong Kong, Hong Kong, Hong Kong (Recruiting)
- The University of Hong Kong — Hong Kong, Hong Kong (Recruiting)
Study contacts
- Study coordinator: Pauline Yeung Ng, MBBS, FHKCP
- Email: pyeungng@hku.hk
- Phone: 39103372
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.