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

NCT06902493 | Completed DMC

• 1 other identifier: SGLT2I-AKI
• Study Type: observational
• Target: 664
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis; Septic Shock; Acute Kidney Injury

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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).

  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

  During ICU stay (from ICU admission to discharge), Maximum 6 months stay

• The need for RRT

  During ICU stay (from ICU admission to discharge), Maximum 6 months stay

• 28-day mortality

  Up to day-28 from ICU admission

Study Arms (2)

SA-AKI Group

Patients diagnosed with sepsis syndromes (sepsis or septic shock) and AKI according to sepsis-3 definition and KDIGO criteria, respectively

Other: No intervention

No AKI group

Patients diagnosed with sepsis syndromes (sepsis or septic shock) and AKI according to sepsis-3 definition

Other: No intervention

Interventions

No intervention OTHER

No intervention

No AKI group; SA-AKI Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Jazan: lead

Study Sites (1)

King Fahd Central Hospital

Al ‘Usaylah, Saudi Arabia

Location

MeSH Terms

Conditions

Sepsis; Shock, Septic; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Mohammed Alshrahili, MSc

  Armed Forces Hospitals, Southern Region, Saudi Arabia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pharmaceutics

Study Record Dates

• First Submitted: March 19, 2025
• First Posted: March 30, 2025
• Study Start: April 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)