Patients with diabetes have poorer cardiac surgery outcomes compared with non-diabetics. Proper blood glucose management is critical to reduce the morbidity and mortality for diabetic patients after cardiac surgery. SGLT2 inhibitors including dapagliflozin as a new diabetes drug can reduce heart failure hospitalization rates and overall cardiovascular mortality in patients with cardiovascular disease. This study is to assess the impact of one year of treatment of SGLT2 inhibitors on cardiac function, postoperative complications and long-term cardiovascular mortality in diabetic patients undergoing cardiac surgery. The investigators use echocardiography to evaluated cardiac function in diabetic patients during perioperative cardiac surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
500
10 mg tablet, oral, once daily, 1-year treatment, postoperation
matching placebo tablet, oral, once daily, 1-year treatment, postoperation
Beijing Anzhen Hospital, Capital Mediacal University
Beijing, Beijing Municipality, China
RECRUITINGDifference in mean EF% between the treatment and control study arms
Echocardiography is used to assess cardiac function.
Time frame: 2 year
Difference in NTproBNP between the treatment and control study arms
NT-proBNP is used to assess cardiac function.
Time frame: 2 year
All-cause postoperative mortality
All-cause mortality identified during two years follow-up.
Time frame: 2 year
Rehospitalization for cardiovascular causes
Rehospitalization due to cardiovascular diseases during two years follow-up.
Time frame: 2 year
Serious postoperative infection
Including postoperative sternal dehiscence, external genital infections, etc.
Time frame: 2 year
Acute postoperative kidney injury
Acute postoperative kidney injury requiring renal replacement therapy
Time frame: 2 year
Hypoglycemia
Identified using ICD9 and ICD10 codes and reported as rates.
Time frame: 2 year
Duration of Hospitalization
Days from date of surgery to hospital discharge.
Time frame: 2 year
Diabetic ketoacidosis
Identified using ICD9 and ICD10 codes and reported as rates.
Time frame: 2 year
Lactic acidosis
Identified using ICD9 and ICD10 codes and reported as rates.
Time frame: 2 year
Post operative atrial fibrillation
In this study, postoperative AF was defined as occurrence of the arrhythmia within the first 7 days after cardiac surgery. AF was considered to be present when an irregular rhythm was detected in the absence of P waves and/or an f wave was detected.
Time frame: 7 days
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