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Impact of Prior SGLT2 Inhibitors Use on the Development and Progression of Sepsis-Associated Acute Kidney Injury

Impact of Prior Sodium-Glucose Co-Transporter 2 Inhibitor Use on the Development and Progression of Sepsis-Associated Acute Kidney Injury

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06902493
Enrollment
664
Registered
2025-03-30
Start date
2024-04-01
Completion date
2025-03-01
Last updated
2025-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury, Sepsis, Septic Shock

Keywords

Sepsis, Acute Kidney Injury, Sepsis-associated acute kidney injury, SGLT2i

Brief 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.

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.

Interventions

OTHERNo intervention

No intervention

Sponsors

University of Jazan
Lead SponsorOTHER_GOV

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years

Inclusion criteria

* All adult (≥ 18 year) patients who were admitted to ICU with sepsis syndromes (sepsis or septic shock), according to sepsis-3 definition.

Exclusion criteria

* Missing data * Renal transplant or tumor * Solitary kidney * Established CKD * Obstructive uropathy * Renal artery stenosis * Pregnancy

Design outcomes

Primary

MeasureTime frameDescription
Odds of sepsis-associated acute kidney injury (AKI) in patients with prior use of SGLT2 inhibitors (SGLT2i)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).

Secondary

MeasureTime frameDescription
ICU length of stayDuring ICU stay (from ICU admission to discharge), Maximum 6 months stayThe number of days of ICU stay
The need for RRTDuring ICU stay (from ICU admission to discharge), Maximum 6 months stayThe prevalence of RRT during ICU stay
28-day mortalityUp to day-28 from ICU admissionThe mortality rate at day 28 in ICU

Countries

Saudi Arabia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026