Dapagliflozin Therapy In Cardiac Surgery

Study Overview
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Brief Summary
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This randomized controlled trial is to assess the effects of perioperative dapagliflozin on type 2 diabetic patients undergoing cardiac surgery

Detailed Description
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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

Official Title
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Effects of Perioperative Dapagliflozin on Type 2 Diabetic Patients Undergoing Cardiac Surgery

Conditions
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Diabetes Mellitus, Type 2, Cardiac Surgery

Intervention / Treatment
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* Drug: Dapagliflozin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years at screening Scheduled for cardiac surgery Diagnosis of Type 2 Diabetes Provision of signed informed consent prior to any study specific procedures Exclusion Criteria: Emergency surgery and non-primary surgery Moderate and severe dehydration; systolic pressure≤90mmHg; unstable haemodynamics History of diabetic ketoacidosis; type 1 diabetes mellitus Receiving therapy with an SGLT2 inhibitor within 4 weeks prior to enrolment Known allergy or hypersensitivity to dapagliflozin or other SGLT-2 inhibitors Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2 or requiring dialysis; unstable or rapidly progressing renal disease at the time of randomisation Serious hepatic disease Women who are pregnant, nursing, or who plan to become pregnant while in the trial Currently enrolled in another investigational drug study, or less than 30 days

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dapagliflozin<br>Dapagliflozin 10 mg | Drug: Dapagliflozin<br>* 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.<br>|
| No Intervention: Standard of care<br>Standard care treatment of diabetes patients during perioperative cardiac surgery in our center | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hs-Troponin-I | high sensitive cardiac troponin-I | within 2 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NT-proBNP | 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 | 
| cardiac function | Echocardiography is used to assess cardiac function | within 5 days after surgery | 
| Renal function | Change of creatinine values, need for renal replacement therapy | 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 | 
| hs-C-reactive protein |  | within 5 days after surgery | 
| Hs-Troponin-I |  | within 5 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SGLT2 inhibitors, Cardiac Surgery, Diabetes Mellitus