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NCT Number: NCT04523064

POST-CABGDM: Empagliflozin in Perioperative CABG

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

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Key information

Conditions

Diabetes Mellitus, Type 2 Acute Kidney Injury Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Bypass Surgery Coronary Artery Disease Coronary Disease Diabetes Mellitus Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Heart Diseases Kidney Diseases Male Urogenital Diseases Metabolic Diseases Myocardial Ischemia Nutritional and Metabolic Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Sao Paulo Medical School - The Heart Institute

São Paulo, 05403010, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Empagliflozin 25 MG

Drug

Patients with diabetes waiting for surgery will receive empagliflozin for at least three months.

Other names: Jardiance 25 mg

Primary outcomes

  1. Acute kidney injury

    Time frame: 3 months

    Development of post-CABG acute kidney injury according to RIFFLE or AKIN or KDIGO criteria

Secondary outcomes

  1. Atrial fibrillation

    Time frame: 3 months

    Development of atrial fibrillation during hospital admission

  2. Pulmonary infection

    Time frame: 3 months

    Development of pulmonary infection during hospital admission

  3. Infection of surgical site

    Time frame: 3 months

    Development of infection of surgical site during hospital admission

  4. ICU readmission

    Time frame: 3 months

    Transfer to ICU during hospital admission

  5. Need for IV insulin

    Time frame: 3 months

    Need for IV insulin during hospital admission

  6. Myocardial Infarction Type 5

    Time frame: 3 months

    Occurence of myocardial infarction type 5 during admission

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Registry information

Official study title

Empagliflozin for Prevention of Acute Kidney Injury in Patients With Type 2 Diabetes Mellitus Undergoing Extracorporeal On-pump CABG: The POST-CABGDM Trial

Acronym: POST-CABGDM

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Aug 21, 2020
Registry last updated
Jun 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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