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This randomized controlled trial is to assess the effects of perioperative dapagliflozin on type 2 diabetic patients undergoing cardiac surgery
Sodium-Glucose Cotransporter 2 Inhibitor(SGLT2i) including dapagliflozin are widely used in the clinical treatment of type 2 diabetes mellitus(T2DM). In recent studies, SGLT2i were found to not only reduce blood glucose but also protect the heart and kidney, which can significantly reduce cardiovascular events, delay the progression of renal failure, greatly improve the quality of life of patients. Patients with T2DM have poorer cardiac surgery outcomes compared with non-diabetics. Based on the promising pharmacological profile of dapagliflozin, we hypothesize that perioperative dapagliflozin therapy would improve postoperative outcomes among patients undergoing cardiac surgery with T2DM. This randomized controlled trial is to assess the effects of perioperative dapagliflozin on type 2 diabetic patients undergoing cardiac surgery
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dapagliflozin | Experimental | Dapagliflozin 10 mg |
|
| Standard of care | No Intervention | Standard care treatment of diabetes patients during perioperative cardiac surgery in our center |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dapagliflozin | Drug | The patients is required to receive dapagliflozin(10mg, q.d.) at least for 3 days until 24 hours before the surgery. Then dapagliflozin will be discontinued and recovered as soon as the patient is able to take oral diet postoperatively. Dapagliflozin wil be ceased five days after surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Hs-Troponin-I | high sensitive cardiac troponin-I | within 2 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Renal function | Acute kidney injury determined by creatinine changes and the need for renal replacement therapy, along with creatinine changes and the need for renal replacement therapy themselves. | within 5 days after surgery |
| NT-proBNP |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Outcome | Diabetic ketoacidosis, severe hypoglycemic events, hypovolemia, urogenital tract infection, Incision infection and serious adverse events | In-hospital time, an average of 2 weeks |
| ICU readmission |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhe Zheng, MD,PhD | Fuwai Hospital, Chinese Academy of Medical Science | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Clinical Research Center for Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College | Beijing | Beijing Municipality | 100037 |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C529054 | dapagliflozin |
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|
N-terminal prohormone of brain natriuretic peptide
| within 5 days after surgery |
| Postoperative atrial fibrillation | In this study, postoperative AF was defined as occurrence of the arrhythmia within the first 5 days after cardiac surgery. AF was considered to be present when an irregular rhythm was detected in the absence of P waves and/or presence an f wave | within 5 days after surgery |
| Perioperative myocardial infarction | Perioperative myocardial infarction was defined as an elevation in cardiac troponin accompanied by evidence of ischemia from ECG, angiographic, or imaging findings. | In-hospital time, an average of 2 weeks |
| cardiac systolic function | Improvement in either left ventricular ejection fraction or left ventricular end-systolic volume, as measured by echocardiography. | within 5 days after surgery |
| cardiac diastolic function | Improvement in either E/e' ratio or left ventricular end-diastolic volume, as measured by echocardiography. | within 5 days after surgery |
| Abnormal blood potassium concentration | blood potassium concentration<3.5mmol/L or >5.5mmol/L | within 5 days after surgery |
| postoperative blood glucose level | within 5 days after surgery |
| Inflammatory biomarkers | high-sensitivity C-reactive protein, interleukin-1β, interleukin-6, interleukin-8, and tumor necrosis factor-α | within 5 days after surgery |
| Hs-Troponin-I | within 5 days after surgery |
| ICU stay | ICU Stay was defined as the duration (in days) of initial postoperative stay in the intensive care unit following cardiac surgery. | an average of 3 days |
| Length of in-hospital time | Length of in-hospital time was defined as the total number of days from the date of surgery to the date of hospital discharge. | an average of 2 weeks |
ICU readmission was defined as any unplanned readmission to the intensive care unit during the index hospitalization after the initial ICU discharge, regardless of cause.
| In-hospital time, an average of 2 weeks |
| Major adverse cardiac cerebrovascular events and its individual components | Major adverse cardiac cerebrovascular events composite includes all-cause mortality, myocardial infarction, stroke, and reoperation | 30 days |
| China |