iSGLT2 in Prevention of Acute Kidney Injury in Patients With Diabetes Mellitus Undergoing CABG Extracorporeal On-Pump

Study Overview
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Brief Summary
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Introduction: Diabetes Mellitus (DM) is a condition known to be associated with coronary artery disease (CAD) and its role as promoter of atherosclerosis is well stablished. The revascularization surgery is commonly indicated to patients with multivessel coronary disease and kidney injury is a prevalent complication in post operation. This work aims to evaluate the impact of a strategy to control Diabetes Mellitus using inhibitors of sodium-glucose cotransporters (ISGLT2) in diabetics patients with assigned myocardial revascularization with cardiopulmonary bypass

Detailed Description
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Random Prospective Study non-blinded with 144 diabetics patients designated to myocardial revascularization with cardiopulmonary bypass . 72 patients will be randomly set to usual treatment provided by health care service and 72 patients will be randomly assigned treatment based on ISGLT2 (Empaglifozin). Patients will receive treatment as set for 3 months until 3 days prior to surgery. Creatinine levels will be measured immediately after surgery and in the following 3 days in post-op. To evaluate the possibility to reduce the acute kidney injury in a randomized group treated with therapy based on ISGLT2.

Official Title
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SGLT2 Inhibitors in Prevention of Acute Kidney Injury in Patients With Diabetes Mellitus Undergoing CABG Extracorporeal On-Pump

Conditions
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Diabetes Mellitus, Type 2, Coronary Artery Disease, Coronary Artery Bypass Surgery, Acute Kidney Injury

Intervention / Treatment
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* Drug: Empagliflozin 25 MG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 Type 2 diabetes mellitus Multivessel CAD documented by coronary angiography with formal indication for CRM. Exclusion Criteria: eGFR <30mL / min / 1.73m2 or dialysis therapy; Inability to sign the informed consent form; Contraindication to CABG on pump; Need for urgent or emergency CABG; Terminal or disabling illness with reduced life expectancy; Pregnancy in progress.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: SGLT2i (empagliflozin)<br>Empagliflozin 25 mg 1 time day for three months | Drug: Empagliflozin 25 MG<br>* Patients with diabetes waiting for surgery will receive empagliflozin for at least three months.<br>* Other names: Jardiance 25 mg;|
| No Intervention: Standard of care<br>Standard care treatment of diabetes patients in our center | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute kidney injury | Development of post-CABG acute kidney injury according to RIFFLE or AKIN or KDIGO criteria | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Atrial fibrillation | Development of atrial fibrillation during hospital admission | 3 months | 
| Pulmonary infection | Development of pulmonary infection during hospital admission | 3 months | 
| Infection of surgical site | Development of infection of surgical site during hospital admission | 3 months | 
| ICU readmission | Transfer to ICU during hospital admission | 3 months | 
| Need for IV insulin | Need for IV insulin during hospital admission | 3 months | 
| Myocardial Infarction Type 5 | Occurence of myocardial infarction type 5 during admission | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute kidney injury, Diabetes, Coronary artery disease, SGLT2i, CABG