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Efficacy of SGLT2 Inhibitors in Adults With Sepsis

ConditionsSepsisInflammationSGLT2 InhibitorsCritically IllOrgan Dysfunction Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospital Authority, Hong Kong

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Current or recent use of SGLT2 inhibitors (within 12wks prior to randomization)

Impaired renal function

Clinically unstable or in refractory hypotension

History of ketoacidosis

Trial design

Design model

Parallel

Treatments tested in this trial

  • Empagliflozin 10 MG

    Drug

    Empagliflozin 10mg once daily from recruitment to hospital discharge

  • Placebo

    Drug

    Placebo single tablet once daily from recruitment to hospital discharge

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: SGLT2 inhibitor empagliflozinExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Mortality

Patient 28-day mortality

Time frame
28-day mortality
2

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

Secondary outcomes

1

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hospital Authority, Hong Kong

Lead sponsor

Chinese University of Hong Kong

Collaborator

Source ClinicalTrials.gov
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