SepsisNCT06902493
Impact of Prior SGLT2 Inhibitors Use on the Development and Progression of Sepsis-Associated Acute Kidney Injury
An observational study of Sepsis and Septic Shock, run by University of Jazan at 1 site in Saudi Arabia.
Trial summary
The primary objective of this study is to investigate whether using SGLT2i may be associated with decreased incidence of sepsis-induced AKI or not. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sepsis, Septic Shock, Acute Kidney Injury
- How many people
- 664 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Apr 2024to 1 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- Adult, Older adult
Study population: All adult (≥ 18 year) patients who were admitted to ICU with sepsis syndromes (sepsis or septic shock), according to sepsis-3 definition.
Who may be able to join
- All adult (≥ 18 year) patients who were admitted to ICU with sepsis syndromes (sepsis or septic shock), according to sepsis-3 definition.
Who cannot join
- Missing data
- Renal transplant or tumor
- Solitary kidney
- Established CKD
- Obstructive uropathy
- Renal artery stenosis
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Prior Sodium-Glucose Co-Transporter 2 Inhibitor Use on the Development and Progression of Sepsis-Associated Acute Kidney Injury
The primary objective of this study is to investigate whether using SGLT2i may be associated with decreased incidence of sepsis-induced AKI or not.
Read the detailed description
The primary objective of this study is to investigate whether using SGLT2i may be associated with decreased incidence of sepsis-induced AKI or not.
- Conditions
- Sepsis, Septic Shock, Acute Kidney Injury
- Being tested
- No intervention
- Keywords
- Sepsis, Acute Kidney Injury, Sepsis-associated acute kidney injury, SGLT2i
- Medical subject headings
- Sepsis, Shock, Septic, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| SA-AKI Group | Patients diagnosed with sepsis syndromes (sepsis or septic shock) and AKI according to sepsis-3 definition and KDIGO criteria, respectively Receives: Other: No intervention | |
| No AKI group | Patients diagnosed with sepsis syndromes (sepsis or septic shock) and AKI according to sepsis-3 definition Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Odds of sepsis-associated acute kidney injury (AKI) in patients with prior use of SGLT2 inhibitors (SGLT2i)
The primary outcome is to determine whether prior use of SGLT2 inhibitors is associated with a reduced odds of developing sepsis-associated AKI. This will be assessed by comparing the frequency of AKI among patients with sepsis who were exposed to SGLT2i prior to hospitalization (cases) versus those who were not exposed (controls).
Measured: The exposure window for SGLT2i use will be defined as any use within 90 days prior to the onset of sepsis. The outcome (sepsis-associated AKI) will be evaluated during the index hospitalization for sepsis.
Secondary outcomes (3)
ICU length of stay
The number of days of ICU stay
Measured: During ICU stay (from ICU admission to discharge), Maximum 6 months stay
The need for RRT
The prevalence of RRT during ICU stay
Measured: During ICU stay (from ICU admission to discharge), Maximum 6 months stay
28-day mortality
The mortality rate at day 28 in ICU
Measured: Up to day-28 from ICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2025
- Study start1 Apr 2024
- Primary completion1 Mar 2025
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 664 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jazan
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ahmad Abdullah Salawi, University of Jazan
- Investigators
- Mohammed Alshrahili, MSc, Principal investigator, Armed Forces Hospitals, Southern Region, Saudi Arabia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06902493
- Sponsor's protocol ID
- SGLT2I-AKI
- Status last verified
- Mar 2025
- First submitted
- 19 Mar 2025
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Prior Sodium-Glucose Co-Transporter 2 Inhibitor Use on the Development and Progression of Sepsis-Associated Acute Kidney Injury
- ClinicalTrials.gov ID
- NCT06902493
- Acronym / sponsor ID
- SGLT2I-AKI
- Conditions
- Sepsis, Septic Shock, Acute Kidney Injury
- Keywords
- Sepsis, Acute Kidney Injury, Sepsis-associated acute kidney injury, SGLT2i
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 664 participants (actual)
- Lead sponsor
- University of JazanOther government
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 30 Mar 2025 (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.
The primary objective of this study is to investigate whether using SGLT2i may be associated with decreased incidence of sepsis-induced AKI or not.
Detailed description
The primary objective of this study is to investigate whether using SGLT2i may be associated with decreased incidence of sepsis-induced AKI or not.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SA-AKI Group | – | Other: No interventionPatients diagnosed with sepsis syndromes (sepsis or septic shock) and AKI according to sepsis-3 definition and KDIGO criteria, respectively |
| No AKI group | – | Other: No interventionPatients diagnosed with sepsis syndromes (sepsis or septic shock) and AKI according to sepsis-3 definition |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All adult (≥ 18 year) patients who were admitted to ICU with sepsis syndromes (sepsis or septic shock), according to sepsis-3 definition.
Key inclusion criteria (1 listed)
- All adult (≥ 18 year) patients who were admitted to ICU with sepsis syndromes (sepsis or septic shock), according to sepsis-3 definition.
Key exclusion criteria (7 listed)
- Missing data
- Renal transplant or tumor
- Solitary kidney
- Established CKD
- Obstructive uropathy
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 |
|---|---|---|
| No interventionNo intervention | Other | No AKI group, SA-AKI Group |
Primary outcome
Odds of sepsis-associated acute kidney injury (AKI) in patients with prior use of SGLT2 inhibitors (SGLT2i)
Time frame: The exposure window for SGLT2i use will be defined as any use within 90 days prior to the onset of sepsis. The outcome (sepsis-associated AKI) will be evaluated during the index hospitalization for sepsis.
The primary outcome is to determine whether prior use of SGLT2 inhibitors is associated with a reduced odds of developing sepsis-associated AKI. This will be assessed by comparing the frequency of AKI among patients with sepsis who were exposed to SGLT2i prior to hospitalization (cases) versus those who were not exposed (controls).
3 secondary outcomes
ICU length of stay
Time frame: During ICU stay (from ICU admission to discharge), Maximum 6 months stay
The need for RRT
Time frame: During ICU stay (from ICU admission to discharge), Maximum 6 months stay
28-day mortality
Time frame: Up to day-28 from ICU admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Mohammed Alshrahili, MSc principal investigator
Armed Forces Hospitals, Southern Region, Saudi Arabia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Septic Shock, run by University of Jazan at 1 site in Saudi Arabia.
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 1 inclusion and 7 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: finished, as of the sponsor's last update on 30 Mar 2025. 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 Saudi Arabia. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Odds of sepsis-associated acute kidney injury (AKI) in patients with prior use of SGLT2 inhibitors (SGLT2i) (time frame: The exposure window for SGLT2i use will be defined as any use within 90 days prior to the onset of sepsis. The outcome (sepsis-associated AKI) will be evaluated during the index hospitalization for sepsis.). 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 30 Mar 2025.