Ignite Creation Date:
2024-05-06 @ 3:06 PM
Last Modification Date:
2024-10-26 @ 1:43 PM
Study NCT ID:
NCT04523064
Status:
COMPLETED
Last Update Posted:
2024-06-10
First Post:
2020-08-18
Brief Title:
POST-CABGDM Empagliflozin in Perioperative CABG
Sponsor:
University of Sao Paulo General Hospital
Organization:
University of Sao Paulo General Hospital
Study Overview
Official Title:
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
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
POST-CABGDM
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
To evaluate the possibility to reduce the acute kidney injury in a randomized group treated with therapy based on ISGLT2
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None