Coronary Artery Disease Clinical Trial
— POST-CABGDMOfficial title:
Empagliflozin for Prevention of Acute Kidney Injury in Patients With Type 2 Diabetes Mellitus Undergoing Extracorporeal On-pump CABG: The POST-CABGDM Trial
Verified date | June 2024 |
Source | University of Sao Paulo General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 155 |
Est. completion date | January 30, 2024 |
Est. primary completion date | January 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Brazil | University of Sao Paulo Medical School - The Heart Institute | Sao Paulo | SP |
Lead Sponsor | Collaborator |
---|---|
University of Sao Paulo General Hospital |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Acute kidney injury | Development of post-CABG acute kidney injury according to RIFFLE or AKIN or KDIGO criteria | 3 months | |
Secondary | Atrial fibrillation | Development of atrial fibrillation during hospital admission | 3 months | |
Secondary | Pulmonary infection | Development of pulmonary infection during hospital admission | 3 months | |
Secondary | Infection of surgical site | Development of infection of surgical site during hospital admission | 3 months | |
Secondary | ICU readmission | Transfer to ICU during hospital admission | 3 months | |
Secondary | Need for IV insulin | Need for IV insulin during hospital admission | 3 months | |
Secondary | Myocardial Infarction Type 5 | Occurence of myocardial infarction type 5 during admission | 3 months |
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