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

Primary Purpose

Diabetes Mellitus, Type 2, Coronary Artery Disease, Coronary Artery Bypass Surgery

Status
Recruiting
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Empagliflozin 25 MG
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Diabetes, Coronary artery disease, SGLT2i, CABG, Acute kidney injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Sao Paulo Medical School - The Heart InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

SGLT2i (empagliflozin)

Standard of care

Arm Description

Empagliflozin 25 mg 1 time day for three months

Standard care treatment of diabetes patients in our center

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Atrial fibrillation
Development of atrial fibrillation during hospital admission
Pulmonary infection
Development of pulmonary infection during hospital admission
Infection of surgical site
Development of infection of surgical site during hospital admission
ICU readmission
Transfer to ICU during hospital admission
Need for IV insulin
Need for IV insulin during hospital admission
Myocardial Infarction Type 5
Occurence of myocardial infarction type 5 during admission

Full Information

First Posted
August 18, 2020
Last Updated
October 18, 2023
Sponsor
University of Sao Paulo General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04523064
Brief Title
iSGLT2 in Prevention of Acute Kidney Injury in Patients With Diabetes Mellitus Undergoing CABG Extracorporeal On-Pump
Acronym
POST-CABGDM
Official Title
SGLT2 Inhibitors in Prevention of Acute Kidney Injury in Patients With Diabetes Mellitus Undergoing CABG Extracorporeal On-Pump
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 22, 2020 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
February 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sao Paulo General Hospital

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Coronary Artery Disease, Coronary Artery Bypass Surgery, Acute Kidney Injury
Keywords
Diabetes, Coronary artery disease, SGLT2i, CABG, Acute kidney injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
155 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SGLT2i (empagliflozin)
Arm Type
Active Comparator
Arm Description
Empagliflozin 25 mg 1 time day for three months
Arm Title
Standard of care
Arm Type
No Intervention
Arm Description
Standard care treatment of diabetes patients in our center
Intervention Type
Drug
Intervention Name(s)
Empagliflozin 25 MG
Other Intervention Name(s)
Jardiance 25 mg
Intervention Description
Patients with diabetes waiting for surgery will receive empagliflozin for at least three months.
Primary Outcome Measure Information:
Title
Acute kidney injury
Description
Development of post-CABG acute kidney injury according to RIFFLE or AKIN or KDIGO criteria
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Atrial fibrillation
Description
Development of atrial fibrillation during hospital admission
Time Frame
3 months
Title
Pulmonary infection
Description
Development of pulmonary infection during hospital admission
Time Frame
3 months
Title
Infection of surgical site
Description
Development of infection of surgical site during hospital admission
Time Frame
3 months
Title
ICU readmission
Description
Transfer to ICU during hospital admission
Time Frame
3 months
Title
Need for IV insulin
Description
Need for IV insulin during hospital admission
Time Frame
3 months
Title
Myocardial Infarction Type 5
Description
Occurence of myocardial infarction type 5 during admission
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carlos V Serrano, MD, PhD
Phone
+551126615241
Email
cvserranojr@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Simone Souza
Phone
+551126615241
Email
simone.souza@incor.usp.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos V Serrano, MD, PhD
Organizational Affiliation
Instituto do Coração - Hospital das Clinicas FMUSP
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Sao Paulo Medical School - The Heart Institute
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
05403010
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabio G Pitta, M.D.
Phone
+5511991784180
Email
fgpitta@gmail.com
First Name & Middle Initial & Last Name & Degree
Simone Souza
Phone
+551126615352
Email
simone.souza@incor.usp.br
First Name & Middle Initial & Last Name & Degree
Fabio G Pitta, MD
First Name & Middle Initial & Last Name & Degree
Eduardo G Lima, MD, PhD
First Name & Middle Initial & Last Name & Degree
Luis Antonio M Cesar, MD, PhD
First Name & Middle Initial & Last Name & Degree
José Otávio C Auler Jr, MD, PHD
First Name & Middle Initial & Last Name & Degree
Luis A Dallan, MD, PHD
First Name & Middle Initial & Last Name & Degree
Celia Strunz, MD, PhD
First Name & Middle Initial & Last Name & Degree
Paula Bolta, MsC
First Name & Middle Initial & Last Name & Degree
Eduardo M Moreira, MD
First Name & Middle Initial & Last Name & Degree
Carlos V Serrano Jr., MD, PhD

12. IPD Sharing Statement

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

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