An interventional study of Empagliflozin 10 MG and Placebo in Sepsis, Inflammation and SGLT2 Inhibitors, sponsored by Hospital Authority, Hong Kong. Recruiting at 3 sites in Hong Kong. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-19.
Sponsored by Hospital Authority, Hong Kong · Not applicable, Interventional, and Other
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.
Sepsis is a leading epidemic in the world, affecting an estimated 48.9 million individuals annually. Patients who develop consequential organ failure requiring admission to the intensive care unit (ICU) has a mortality of up to 42%. In Hong Kong, sepsis was the second most common cause of ICU admission, accounting for 16.9% of the 14,068 patient admissions in 2018. Sepsis has remained as one of the top 10 leading causes of death in Hong Kong in the past decade.
Recent randomized controlled trials evaluating various therapies in sepsis have not yielded encouraging results. Targeted therapeutic options including adjunctive glucocorticoid therapy, intravenous vitamin C, and sepsis bundles have not been associated with improved clinical outcomes in patients with sepsis. Administration of antibiotics for source control has remained as the only treatment proven effective in sepsis for two decades. There is an urgent unmet need to identify therapies that may modulate the adverse outcomes of sepsis.
Sodium-glucose cotransporter-2 (SGLT2) inhibitors are a class of medication that reduces reabsorption of glucose from the kidneys by modulating the sodium-glucose cotransporter in the renal tubules. Although originally developed as a drug for type 2 diabetes, subsequent large randomized clinical trials have firmly established the clinical efficacy of SGLT2 inhibitors in improving cardiovascular and renal outcomes, irrespective of diabetes status. Patients who received SGLT2 inhibitors had a 32% relative risk reduction in all-cause mortality, 40% reduction in adverse renal outcomes, and 30% reduction in hospitalization for heart failure, compared with placebo.
The investigators hypothesize that SGLT2 inhibitors, as compared with placebo, will improve clinical outcomes of patients with sepsis who are receiving standard care.
(i) The primary objective is to examine the efficacy and safety of SGLT2 inhibitors on clinical outcomes in patients with sepsis.
(ii) The secondary objective is to examine the effect of SGLT2 inhibitors on inflammatory markers in patients with sepsis.
(iii) The tertiary objective is to examine the feasibility of conducting a multicenter double-blind randomized placebo-controlled trial in the ICUs of Hong Kong.
Adult patients (age≥18 years) with new onset sepsis and admitted to the ICU will be considered for recruitment based on the study inclusion/exclusion criteria. Eligible subjects will be randomly assigned to the intervention group or the control group in a 1:1 ratio. In the intervention group, the SGLT2 inhibitor empagliflozin 10mg orally daily will be given in addition to standard care until hospital discharge. In the control group, a placebo tablet once orally daily will be given in addition to standard care until hospital discharge. All patients will be followed up daily until hospital discharge or transfer to another facility. Blood samples will be collected and sent for an assay that measures the levels of key inflammatory markers.
2,416 studies on the registry are indexed under Sepsis; 541 are open to participants now.
This study's planned enrollment of 60 is below the median of 102 across 1,165 interventional studies indexed under Sepsis.
Browse Sepsis studies →Hospital Authority, Hong Kong is the lead sponsor of 79 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
10mg daily from recruitment to hospital discharge
Drug: Empagliflozin 10 MG
1 tablet daily from recruitment to hospital discharge
Drug: Placebo
Empagliflozin 10mg once daily from recruitment to hospital discharge
Also known as: Jardiance
Placebo single tablet once daily from recruitment to hospital discharge
Mortality
Patient 28-day mortality
Time frame: 28-day mortality
Change in Sequential Organ Failure Assessment (SOFA) score
Score is based on lab results and clinical data. Higher SOFA scores indicate higher risk of ICU mortality. Lower SOFA scores predicts lower risk of ICU mortality.
Time frame: Baseline and day 7 score
Interleukin-6, Interleukin-1 beta, TNF-a, IFN-gamma, Procalcitonin, C-reactive protein
These markers are selected based on observed associations with SGLT2 inhibitors in experimental studies.
Time frame: Baseline and day 7
Plan to share: Undecided
Started Mar 2025 (actual). Primary completion is estimated for Feb 2027, 23 months after the start.
Of 301 non-industry interventional studies with no phase under Sepsis, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 42. This study's planned 23 months is close to that.
Counting every sponsor, half of 324 studies reached it within 22 months; a quarter within 12 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Empagliflozin
Hospital Authority, Hong Kong