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

Completed

• Conditions: Sepsis; Septic Shock; Acute Kidney Injury

• Registration Number: NCT06902493
• Lead Sponsor: University of Jazan

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.

Study Timeline

• Study Start: 2024-04-01
• Status Verified: 2025-03
• Primary Completion: 2025-03-01
• Study Completion: 2025-03-01
• Study First Submitted: 2025-03-19
• Study First Submitted QC: 2025-03-28
• Last Update Submitted: 2025-03-28
• Study First Posted: 2025-03-30
• Last Update Posted: 2025-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 664

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
28-day mortality	Up to day-28 from ICU admission	The mortality rate at day 28 in ICU
ICU length of stay	During ICU stay (from ICU admission to discharge), Maximum 6 months stay	The number of days of ICU stay
The need for RRT	During ICU stay (from ICU admission to discharge), Maximum 6 months stay	The prevalence of RRT during ICU stay

Trial Locations

Locations (1)

King Fahd Central Hospital; 🇸🇦 Al 'Usaylah, Saudi Arabia