atrial fibrillation. Unspecified atrial fibrillation and atrial flutter
Conditions
Interventions
Intervention 1: Intervention group: The patients will receive empagliflozin 10 mg daily along with their other medications from the day of randomization to the discharge day (max= 30 days). Interventi
Sponsors
Iran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: patients older than 18 years of age scheduled for elective coronary artery bypass graft surgery patients who agree to receive treatment with empagliflozin
Exclusion criteria
Exclusion criteria: patients unwillingness to participate history of diabetes mellitus patients receiving empagliflozin for another indication eGFR<30 ML/MIN sever hepatic disease history of ketoacidosis history of atrial fibrillation hystory of hypersensivity to empagliflozin or any excipients patients who have participated in any other clinical trial unstable or rapidly progressive renal disease patients undergoing urgent surgery unstable hemodynamic profile history of recurrent uti positive urine culture symptomatic abacteriuria asymptomatic bacteriuria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of post operative atrial fibrillation. Timepoint: Until the discharge day (max= 30 days). Method of measurement: Daily monitoring of 12-lead 24-hour ECG strips by resident physician. | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of other life-threatening arrhythmia. Timepoint: Until the discharge day from special wards (max= 30 days). Method of measurement: Other supraventricular tachycardia (SVT) of at least 30 seconds duration and documented by rhythm strip or 12-lead ECG.Ventricular tachycardia (VT) of at least 30 seconds duration and documented by rhythm strip or 12-lead ECG.Ventricular fibrillation (VF) of at least 30 seconds duration and documented by rhythm strip or 12-lead ECG.;Rate of post-operative acute kidney injury. Timepoint: 7 days after surgery. Method of measurement: AKI occurring within 7 days of CABG using the KDIGO definition of AKI.;Need for vasopressor/inotrope. Timepoint: Until the discharge day from special wards (max= 30 days). Method of measurement: The amount of average daily vasopressor/inotrope dose.;Duration of hospitalization. Timepoint: Until discharge or death. Method of measurement: Total hospital length-of-stay.;In-hospital mortality. Timepoint: Until the discharge day (max= 30 days). Method of measurement: In-hospital mortality, including cause-specific mortality: cardiac arrhythmic, cardiac nonarrhythmic, non-cardiovascular.;Rate of life-threatening infections. Timepoint: Until the discharge day (max= 30 days). Method of measurement: Any adjudicated clinically and laboratory confirmed systemic infection which leads to parenteral broad spectrum antibiotic initiation.;Rate of genitourinary tract infections. Timepoint: Until the discharge day (max= 30 days). Method of measurement: Any adjudicated laboratory and clinically confirmed urinary tract infections including cystitis, pyelonephritis, prostatitis, urethritis, and vaginitis.;Rate of hypoglycemia. Timepoint: Until the discharge day (max= 30 days). Method of measurement: Any recorded episode of hypoglycemia defined as BS< 70 mg/dL.;Rate of ketoacidosis. Timepoint: Until the discharge day (max= 30 days). Method of measurement: Any adjudicated clinically and laboratory confirmed ketoacidosis.;Ischemi | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactHessam Kakavand
Iran University of Medical Sciences
Outcome results
None listed