POST-CABGDM: Empagliflozin in Perioperative CABG

Phase 4

Completed

• Conditions: Coronary Artery Disease; Diabetes Mellitus, Type 2; Coronary Artery Bypass Surgery; Acute Kidney Injury
• Interventions: Drug: Empagliflozin 25 MG

• Registration Number: NCT04523064
• Lead Sponsor: University of Sao Paulo General Hospital

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.

Study Timeline

• Study First Submitted: 2020-08-18
• Study First Submitted QC: 2020-08-20
• Study First Posted: 2020-08-21
• Study Start: 2020-09-22
• Primary Completion: 2024-01-30
• Study Completion: 2024-01-30
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-07
• Last Update Posted: 2024-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 155

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SGLT2i (empagliflozin)	Empagliflozin 25 MG	Empagliflozin 25 mg 1 time day for three months

Primary Outcome Measures

Name	Time	Method
Acute kidney injury	3 months	Development of post-CABG acute kidney injury according to RIFFLE or AKIN or KDIGO criteria

Secondary Outcome Measures

Name	Time	Method
Atrial fibrillation	3 months	Development of atrial fibrillation during hospital admission
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
ICU readmission	3 months	Transfer to ICU 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

Trial Locations

Locations (1)

University of Sao Paulo Medical School - The Heart Institute; 🇧🇷 Sao Paulo, SP, Brazil