Sepsis. Other sepsis
Conditions
Interventions
Intervention 1: Intervention group: Eligible patients will receive 10 mg empagliflozin (Abidi Co, Tehran, Iran) tablet for 7 days. Intervention 2: Control group: Patients will receive placebo (Abidi C
Sponsors
Esfahan University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Confirmed diagnosis of sepsis based on Sepsis-3 criteria No history of chronic kidney disease No prior use of sodium glucose cotransporter inhibitor 2 (SGLT2) medications Expected intensive care unit stay of at least 72 hours Systolic blood pressure = 90 mmHg without vasopressors Ability to tolerate medication and enteral nutrition
Exclusion criteria
Exclusion criteria: Type 1 diabetes eGFR less than 30 mL/min/1.73m² Need for renal replacement therapy within 24 hours Radiographic contrast agent use within the past 72 hours Use of nephrotoxic antibiotics (aminoglycosides or colistin) within 24 hours Cirrhosis with Child-Pugh class C or acute liver failure History of organ transplantation Pregnancy or breastfeeding (positive ß-hCG or lactating)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of acute kidney injury. Timepoint: Day 7 after intervention or until discharge from ICU. Method of measurement: KDIGO (Kidney Disease Improving Global Outcomes) Criteria.;Mortality. Timepoint: Day 7 after intervention or until discharge from ICU. Method of measurement: Medical records. | — |
Secondary
| Measure | Time frame |
|---|---|
| Frequency of stress induced hyperglycemia. Timepoint: Day one, two, four and seven (or until discharge from ICU) after intervention. Method of measurement: Blood sugar results recorded in the medical record.;Blood pressure. Timepoint: Day one, two, four and seven (or until discharge from ICU) after intervention. Method of measurement: Intensive care monitoring device.;Frequency of diabetic ketoacidosis during intervention. Timepoint: Day one, two, four and seven (or until discharge from ICU) after intervention. Method of measurement: Diagnostic criteria of diabetic ketoacidosis in patient medical records and laboratory results.;ICU length of stay. Timepoint: Before intervention to discharge or death. Method of measurement: Medical records.;Need for mechanical ventilation. Timepoint: Before intervention to discharge or death. Method of measurement: Record of mechanical ventilation in the medical record. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactSarah Mousavi
Esfahan University of Medical Sciences
Outcome results
None listed