Septic ShockPhase 3GLIFLOSHOCKNCT07488689
Assessing the Efficacy of Dapagliflozin as a Vasculoprotective Treatment in Septic Shock Patients With Microcirculatory Dysfunction
A Phase 3 study testing Dapaglifozin in people with Septic Shock, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Microcirculatory dysfunction is a key driver of organ failure and mortality in septic shock, characterized by endothelial injury and impaired vasoregulation. Despite its strong prognostic value, it remains unaddressed by current therapies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock
- What is being tested?
- Dapaglifozin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 568 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2026to Jul 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient aged ≥ 18 years
- Hospitalized in ICU for septic shock according to Sepsis-3 definition (PMID: 26903338). Septic shock should be the primary reason for admission.
- Septic shock diagnosed for less than 12 hours prior to randomization
- Skin mottling (mottling score ≥ 2) according to Ait-Oufella and/or prolonged capillary refill time > 3 seconds
- Patient benefiting from social health insurance (or having a close relative who is a beneficiary)
- Patient or legal representative having signed an informed consent to participate in the study. In case immediate consent is not possible, an emergency procedure will be applied in accordance with current regulations
Who cannot join
- Patient in whom oral administration is not possible at the initial stage (e.g., emergency digestive surgery, acute mesenteric ischemia, etc.).
- Patient treated with SGLT2 inhibitor before ICU admission
- Hypoglycemia < 0.5 g/L (2.75 mmol/L)
- End-stage kidney disease undergoing maintenance dialysis
- Medical history of type 1 diabetes (gliflozins are not authorized for treatment of this type of diabetes)
- Medical history of diabetic ketoacidosis
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- Ongoing Fournier's gangrene
- Current treatment with lithium
- Cirrhose child C
- Do not resuscitate order at inclusion in the study
- Concomitant participation in another interventional therapeutic trial
- Patient deprived of liberty or under legal protection (guardianship, conservatorship, or legal protection)
- Pregnancy or breastfeeding
- Contraindications to dapagliflozin
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hamid MERDJI, MD, PhD contact
France1 site
Hôpital Civil, Service de médecine intensive et réanimation, Hôpitaux Universitaires de Strasbourg
Strasbourg
Hamid MERDJI, MD, PhD, 03 69 55 11 23 ext. +33, hamid.merdji@chru-strasbourg.fr
About this study
Microcirculatory dysfunction is a key driver of organ failure and mortality in septic shock, characterized by endothelial injury and impaired vasoregulation. Despite its strong prognostic value, it remains unaddressed by current therapies. SGLT-2 inhibitors (SGLT-2i) have shown promising vasculoprotective, anti-inflammatory, and glucose-lowering effects that may help restore endothelial function, reduce vascular leakage, and manage stress-induced hyperglycemia-factors central to septic shock pathophysiology. Preclinical and clinical observational studies suggest potential benefits, but clinical research in this specific context is lacking. This trial aims to evaluate the efficacy and safety of SGLT-2i in septic shock patients with clinical signs of microcirculatory failure, addressing a critical unmet medical need.
Septic shock management relies on rapid infection control, hemodynamic stabilization with fluids and vasopressors, and supportive care, with corticosteroids used in select cases. However, this standardized approach faces major limitations due to patient heterogeneity, treatment-related complications (e.g., fluid overload, vasopressor side effects), and rising antimicrobial resistance. Adjunctive therapies have largely failed to improve outcomes, reflecting the complex pathophysiology of septic shock. These challenges highlight a pressing need for novel, targeted interventions and a shift toward personalized treatment strategies.
Read more
The investigators hypothesize that early administration of SGLT-2 inhibitors within 14 hours of septic shock onset in patients showing signs of microcirculatory dysfunction will improve 28-day outcomes mainly by targeting endothelial and microvascular injury. Expected benefits include reduced mortality and organ dysfunction, faster recovery with lower resource use, a favorable safety profile, and potential for global implementation as a cost-effective adjunctive therapy.
This study will be a multicenter, prospective, randomized, and comparative double-blind trial. All patients admitted with septic shock in the ICU will be screened for trial eligibility criteria.
After verifying the eligibility criteria and obtaining patient or family consent, or after an emergency inclusion procedure, eligible patients will be randomized in a 1:1 ratio to receive either Dapagliflozin (10 mg once daily) or matching placebo in addition to standard-of-care.
Patients will be followed up for 1 year or until death, whichever occurs first.
- Conditions
- Septic Shock
- Being tested
- Dapaglifozin, Placebo
- Keywords
- microcirculatory dysfunction, septic shock, dapagliflozin, SGLT-2i, gliflozins
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DapaglifozinDrug
Oral Dapaglifozin 10mg once-daily administration, for 7 days
PlaceboDrug
Oral Placebo once-daily administration, for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozin | Experimental | administration of once-daily oral dapagliflozin 10 mg for 7 days Receives: Drug: Dapaglifozin |
| Placebo | Placebo comparator | administration of once-daily oral placebo for 7 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite endpoint including all-cause mortality, weaning of vasopressor, and initiation of renal replacement therapy.
These outcomes will be observed up to 28 days post-randomization, with events censored at the point of hospital discharge
Measured: weaning of vasopressor: day 5, all-cause mortality: day 28, initiation of renal replacement therapy: day 28.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study startJul 2026 (estimated)
- Primary completionAug 2029 (estimated)
- Study completionJul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 568 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ferhat MEZIANI, MD, PhD, Principal investigator, Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07488689
- Sponsor's protocol ID
- RC25_0052
- Other IDs
- 2025-524820-23-00, 2025
- Acronym
- GLIFLOSHOCK
- Status last verified
- Mar 2026
- First submitted
- 17 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Efficacy of Dapagliflozin as a Vasculoprotective Treatment in Septic Shock Patients With Microcirculatory Dysfunction
- ClinicalTrials.gov ID
- NCT07488689
- Acronym / sponsor ID
- GLIFLOSHOCK / RC25_0052
- Conditions
- Septic Shock
- Keywords
- microcirculatory dysfunction, septic shock, dapagliflozin, SGLT-2i, gliflozins
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 568 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Jul 2026 (estimated)
- Primary completion
- Aug 2029 (estimated)
- Study completion
- Jul 2030 (estimated)
- First posted
- 23 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Microcirculatory dysfunction is a key driver of organ failure and mortality in septic shock, characterized by endothelial injury and impaired vasoregulation. Despite its strong prognostic value, it remains unaddressed by current therapies. SGLT-2 inhibitors (SGLT-2i) have shown promising vasculoprotective, anti-inflammatory, and glucose-lowering effects that may help restore endothelial function, reduce vascular leakage, and manage stress-induced hyperglycemia-factors central to septic shock pathophysiology. Preclinical and clinical observational studies suggest potential benefits, but clinical research in this specific context is lacking. This trial aims to evaluate the efficacy and safety of SGLT-2i in septic shock patients with clinical signs of microcirculatory failure, addressing a critical unmet medical need.
Septic shock management relies on rapid infection control, hemodynamic stabilization with fluids and vasopressors, and supportive care, with corticosteroids used in select cases. However, this standardized approach faces major limitations due to patient heterogeneity, treatment-related complications (e.g., fluid overload, vasopressor side effects), and rising antimicrobial resistance. Adjunctive therapies have largely failed to improve outcomes, reflecting the complex pathophysiology of septic shock. These challenges highlight a pressing need for novel, targeted interventions and a shift toward personalized treatment strategies.
The investigators hypothesize that early administration of SGLT-2 inhibitors within 14 hours of septic shock onset in patients showing signs of microcirculatory dysfunction will improve 28-day outcomes mainly by targeting endothelial and microvascular injury. Expected benefits include reduced mortality and organ dysfunction, faster recovery with lower resource use, a favorable safety profile, and potential for global implementation as a cost-effective adjunctive therapy.
This study will be a multicenter, prospective, randomized, and comparative double-blind trial. All patients admitted with septic shock in the ICU will be screened for trial eligibility criteria.
After verifying the eligibility criteria and obtaining patient or family consent, or after an emergency inclusion procedure, eligible patients will be randomized in a 1:1 ratio to receive either Dapagliflozin (10 mg once daily) or matching placebo in addition to standard-of-care.
Patients will be followed up for 1 year or until death, whichever occurs first.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dapagliflozin | Experimental | Drug: Dapaglifozinadministration of once-daily oral dapagliflozin 10 mg for 7 days |
| Placebo | Placebo comparator | Drug: Placeboadministration of once-daily oral placebo for 7 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient aged ≥ 18 years
- Hospitalized in ICU for septic shock according to Sepsis-3 definition (PMID: 26903338). Septic shock should be the primary reason for admission.
- Septic shock diagnosed for less than 12 hours prior to randomization
- Skin mottling (mottling score ≥ 2) according to Ait-Oufella and/or prolonged capillary refill time > 3 seconds
- Patient benefiting from social health insurance (or having a close relative who is a beneficiary)
Key exclusion criteria (14 listed)
- Patient in whom oral administration is not possible at the initial stage (e.g., emergency digestive surgery, acute mesenteric ischemia, etc.).
- Patient treated with SGLT2 inhibitor before ICU admission
- Hypoglycemia < 0.5 g/L (2.75 mmol/L)
- End-stage kidney disease undergoing maintenance dialysis
- Medical history of type 1 diabetes (gliflozins are not authorized for treatment of this type of diabetes)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DapaglifozinOral Dapaglifozin 10mg once-daily administration, for 7 days | Drug | Dapagliflozin |
| PlaceboOral Placebo once-daily administration, for 7 days | Drug | Placebo |
Primary outcome
Composite endpoint including all-cause mortality, weaning of vasopressor, and initiation of renal replacement therapy.
Time frame: weaning of vasopressor: day 5, all-cause mortality: day 28, initiation of renal replacement therapy: day 28.
These outcomes will be observed up to 28 days post-randomization, with events censored at the point of hospital discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
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ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers
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Sepsis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hamid MERDJI, MD, PhD contact
Ferhat MEZIANI, MD, PhD principal investigator
Hôpitaux Universitaires de Strasbourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dapaglifozin in people with Septic Shock, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah HUSTACHE (03 88 11 54 15 ext. +33, dpidrci@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite endpoint including all-cause mortality, weaning of vasopressor, and initiation of renal replacement therapy. (time frame: weaning of vasopressor: day 5, all-cause mortality: day 28, initiation of renal replacement therapy: day 28.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.