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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SGLT2i (empagliflozin) | Active Comparator | Empagliflozin 25 mg 1 time day for three months |
|
| Standard of care | No Intervention | Standard care treatment of diabetes patients in our center |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Empagliflozin 25 MG | Drug | Patients with diabetes waiting for surgery will receive empagliflozin for at least three months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acute kidney injury | Development of post-CABG acute kidney injury according to RIFFLE or AKIN or KDIGO criteria | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Atrial fibrillation | Development of atrial fibrillation during hospital admission | 3 months |
| Pulmonary infection | Development of pulmonary infection during hospital admission |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carlos V Serrano, MD, PhD | Instituto do Coração - Hospital das Clinicas FMUSP | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Sao Paulo Medical School - The Heart Institute | São Paulo | São Paulo | 05403010 | Brazil |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003324 | Coronary Artery Disease |
| D058186 | Acute Kidney Injury |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C570240 | empagliflozin |
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| 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 |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |