Status:
UNKNOWN
Effects of SGLT2 Inhibitor on Type 2 Diabetic Patients Undergoing Cardiac Surgery
Lead Sponsor:
Hongchang Guo
Conditions:
Diabetes Mellitus, Type 2
Cardiac Surgery
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 c...
Eligibility Criteria
Inclusion
- Age ≥ 18 years old at index date.
- Diagnosis of Type 2 Diabetes.
- Scheduled for cardiac surgery (coronary artery bypass grafting, valve replacement, ventricular assist device, cardiac transplantation, or any other surgery requiring thoracotomy).
- eGFR ≥ 60 ml/min/1.73 m2.
- Patients who agree to receive treatment with SGLT2 inhibitors.
- Patients must be on current stable hemodynamic profile , without dehydration.
Exclusion
- Diagnosis of Type 1 Diabetes.
- eGFR \< 60 ml/min/1.73 m2.
- Unstable or rapidly progressive renal disease.
- Hypersensitivity to dapagliflozin or any excipients.
- Severe hepatic disease.
- Patients who have participated in any other clinical trial of an investigational medicinal product within the previous 30 days.
- Any other reason considered by a study physician to be inappropriate for inclusion.
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2023
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT04340908
Start Date
January 1 2021
End Date
June 1 2023
Last Update
October 7 2021
Active Locations (1)
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1
Beijing Anzhen Hospital, Capital Mediacal University
Beijing, Beijing Municipality, China, 100000