Efficacy of SGLT2 Inhibitors in Adults with Sepsis

March 17, 2025 updated by: Pauline Yeung Ng, MD, Hospital Authority, Hong Kong

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Pauline Yeung Ng, MBBS, FHKCP
  • Phone Number: 852 39103372
  • Email: pyeungng@hku.hk

Study Contact Backup

  • Name: Calvin Tam, BSN, RN
  • Phone Number: 44 07783323202
  • Email: ct7331@hku.hk

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong, 00
        • Recruiting
        • The University of Hong Kong
        • Contact:
        • Contact:
          • Pauline Yeung Ng, MBBS, FHKCP
      • Hong Kong, Hong Kong, 0000
        • Not yet recruiting
        • 4/F Main Clinical Block and Trauma Centre, Prince of Wales Hospital, Shatin, New Territories, Hong Kong
        • Contact:
      • Hong Kong, Hong Kong, 0000
        • Recruiting
        • Adult Intensive Care Unit, Queen Mary Hospital, 102 Pok Fu Lam Road, Hong Kong
        • Contact:
          • Pauline Yeung Ng, MBBS, FHKCP
          • Phone Number: 852 39103372
          • Email: pyeungng@hku.hk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SGLT2 inhibitor empagliflozin
10mg daily from recruitment to hospital discharge
Drug: Empagliflozin 10 MG
Empagliflozin 10mg once daily from recruitment to hospital discharge
Other Names:
  • Jardiance
Placebo Comparator: Placebo
1 tablet daily from recruitment to hospital discharge
Drug: Placebo
Placebo single tablet once daily from recruitment to hospital discharge

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Sequential Organ Failure Assessment (SOFA) score
Time Frame: Baseline and day 7 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.
Baseline and day 7 score
Mortality
Time Frame: 28-day mortality
Patient 28-day mortality
28-day mortality

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Interleukin-6, Interleukin-1 beta, TNF-a, IFN-gamma, Procalcitonin, C-reactive protein
Time Frame: Baseline and day 7
These markers are selected based on observed associations with SGLT2 inhibitors in experimental studies.
Baseline and day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Authority, Hong Kong

Collaborators

Chinese University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 5, 2025

Primary Completion (Estimated)

February 28, 2027

Study Completion (Estimated)

February 28, 2027

Study Registration Dates

First Submitted

June 19, 2024

First Submitted That Met QC Criteria

June 19, 2024

First Posted (Actual)

June 25, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 17, 2025

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UW 23-609

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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