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

Coronary Artery Disease Clinical Trial

— POST-CABGDM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04523064
• Other study ID #: 4957/19/176
• Status: Recruiting
• Phase: Phase 4
• Start date: September 22, 2020
• Est. completion date: February 28, 2024

Study information

• Verified date: October 2023
• Source: University of Sao Paulo General Hospital
• Contact: Carlos V Serrano, MD, PhD
• Phone: +551126615241
• Email: cvserranojr[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 155
• Est. completion date: February 28, 2024
• Est. primary completion date: November 30, 2023
• 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.

Related Conditions & MeSH terms

• Acute Kidney Injury
• Coronary Artery Bypass Surgery
• Coronary Artery Disease
• Coronary Disease
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Myocardial Ischemia
• Wounds and Injuries

Intervention

Drug:
• Empagliflozin 25 MG
Patients with diabetes waiting for surgery will receive empagliflozin for at least three months.

Locations

Country	Name	City	State
Brazil	University of Sao Paulo Medical School - The Heart Institute	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

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