Trials / Completed
CompletedNCT04523064
POST-CABGDM: Empagliflozin in Perioperative CABG
Empagliflozin for Prevention of Acute Kidney Injury in Patients With Type 2 Diabetes Mellitus Undergoing Extracorporeal On-pump CABG: The POST-CABGDM Trial
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 155 (actual)
- Sponsor
- University of Sao Paulo General Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Empagliflozin 25 MG | Patients with diabetes waiting for surgery will receive empagliflozin for at least three months. |
Timeline
- Start date
- 2020-09-22
- Primary completion
- 2024-01-30
- Completion
- 2024-01-30
- First posted
- 2020-08-21
- Last updated
- 2024-06-10
Locations
1 site across 1 country: Brazil
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04523064. Inclusion in this directory is not an endorsement.