Acute Kidney Injury, Coronary Artery Bypass Surgery, Coronary Artery Disease, Diabetes Mellitus, Type 2
Conditions
Keywords
Diabetes, Coronary artery disease, SGLT2i, CABG, Acute kidney injury
Brief summary
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
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.
Interventions
DRUGEmpagliflozin 25 MG
Patients with diabetes waiting for surgery will receive empagliflozin for at least three months.
Sponsors
University of Sao Paulo General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute kidney injury | 3 months | Development of post-CABG acute kidney injury according to RIFFLE or AKIN or KDIGO criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pulmonary infection | 3 months | Development of pulmonary infection during hospital admission |
| Infection of surgical site | 3 months | Development of infection of surgical site during hospital admission |
| Atrial fibrillation | 3 months | Development of atrial fibrillation during hospital admission |
| Need for IV insulin | 3 months | Need for IV insulin during hospital admission |
| Myocardial Infarction Type 5 | 3 months | Occurence of myocardial infarction type 5 during admission |
| ICU readmission | 3 months | Transfer to ICU during hospital admission |
Countries
Brazil
Outcome results
None listed