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

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

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

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease; Diabetes Mellitus, Type 2; Acute Kidney Injury; Coronary Artery Bypass Surgery
• Intervention / Treatment: Drug: Empagliflozin 25 MG

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 Type: Interventional
• Enrollment (Estimated): 155
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Carlos V Serrano, MD, PhD; Phone Number: +551126615241; Email: cvserranojr@gmail.com
• Study Contact Backup: Name: Simone Souza; Phone Number: +551126615241; Email: simone.souza@incor.usp.br

Study Locations

• Brazil
  • SP
    • Sao Paulo, SP, Brazil, 05403010
      • Recruiting
      • University of Sao Paulo Medical School - The Heart Institute
      • Sub-Investigator: José Otávio C Auler Jr, MD, PHD
      • Contact: Fabio G Pitta, M.D.; Phone Number: +5511991784180; Email: fgpitta@gmail.com
      • Contact: Simone Souza; Phone Number: +551126615352; Email: simone.souza@incor.usp.br
      • Sub-Investigator: Fabio G Pitta, MD
      • Principal Investigator: Eduardo G Lima, MD, PhD
      • Sub-Investigator: Luis Antonio M Cesar, MD, PhD
      • Sub-Investigator: Luis A Dallan, MD, PHD
      • Sub-Investigator: Celia Strunz, MD, PhD
      • Sub-Investigator: Paula Bolta, MsC
      • Sub-Investigator: Eduardo M Moreira, MD
      • Principal Investigator: Carlos V Serrano Jr., MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: SGLT2i (empagliflozin); Empagliflozin 25 mg 1 time day for three months	Drug: Empagliflozin 25 MG; Patients with diabetes waiting for surgery will receive empagliflozin for at least three months.; Other Names: Jardiance 25 mg
No Intervention: Standard of care; Standard care treatment of diabetes patients in our center

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute kidney injury	Development of post-CABG acute kidney injury according to RIFFLE or AKIN or KDIGO criteria	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Atrial fibrillation	Development of atrial fibrillation during hospital admission	3 months
Pulmonary infection	Development of pulmonary infection during hospital admission	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

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital
• Investigators: Principal Investigator: Carlos V Serrano, MD, PhD, Instituto do Coração - Hospital das Clinicas FMUSP

Study record dates

Study Major Dates

• Study Start (Actual): September 22, 2020
• Primary Completion (Estimated): November 30, 2023
• Study Completion (Estimated): February 28, 2024

Study Registration Dates

• First Submitted: August 18, 2020
• First Submitted That Met QC Criteria: August 20, 2020
• First Posted (Actual): August 21, 2020

Study Record Updates

• Last Update Posted (Actual): October 19, 2023
• Last Update Submitted That Met QC Criteria: October 18, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Diabetes; Coronary artery disease; CABG; Acute kidney injury; SGLT2i
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Kidney Diseases; Urologic Diseases; Endocrine System Diseases; Renal Insufficiency; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Diabetes Mellitus; Diabetes Mellitus, Type 2; Wounds and Injuries; Acute Kidney Injury; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Sodium-Glucose Transporter 2 Inhibitors; Empagliflozin
• Other Study ID Numbers: 4957/19/176

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes