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Completed

NCT Number: NCT06902493

Impact of Prior SGLT2 Inhibitors 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.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

King Fahd Central Hospital

Al ‘Usaylah, Saudi Arabia

About this study

The primary objective of this study is to investigate whether using SGLT2i may be associated with decreased incidence of sepsis-induced AKI or not.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. 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).

Secondary outcomes

  1. ICU length of stay

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

    The number of days of ICU stay

  2. The need for RRT

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

    The prevalence of RRT during ICU stay

  3. 28-day mortality

    Time frame: Up to day-28 from ICU admission

    The mortality rate at day 28 in ICU

Sponsors and collaborators

Lead sponsor

University of Jazan

Other Gov

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 30, 2025
Registry last updated
Mar 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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