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Clinical Trial Details

Trial ID: L4663
Source ID: NCT04340908
Associated Drug: Dapagliflozin 10 Mg
Title: Effects of SGLT2 Inhibitor on Type 2 Diabetic Patients Undergoing Cardiac Surgery
Acronym:
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2|Cardiac Surgery
Interventions: DRUG: Dapagliflozin 10 MG|DRUG: Placebos
Outcome Measures: Primary: Difference in mean EF% between the treatment and control study arms, Echocardiography is used to assess cardiac function., 2 year|Difference in NTproBNP between the treatment and control study arms, NT-proBNP is used to assess cardiac function., 2 year | Secondary: All-cause postoperative mortality, All-cause mortality identified during two years follow-up., 2 year|Rehospitalization for cardiovascular causes, Rehospitalization due to cardiovascular diseases during two years follow-up., 2 year|Serious postoperative infection, Including postoperative sternal dehiscence, external genital infections, etc., 2 year|Acute postoperative kidney injury, Acute postoperative kidney injury requiring renal replacement therapy, 2 year|Hypoglycemia, Identified using ICD9 and ICD10 codes and reported as rates., 2 year|Duration of Hospitalization, Days from date of surgery to hospital discharge., 2 year|Diabetic ketoacidosis, Identified using ICD9 and ICD10 codes and reported as rates., 2 year|Lactic acidosis, Identified using ICD9 and ICD10 codes and reported as rates., 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., 7 days
Sponsor/Collaborators: Sponsor: Hongchang Guo
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 500
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2021-01-01
Completion Date: 2023-06-01
Results First Posted:
Last Update Posted: 2021-10-07
Locations: Beijing Anzhen Hospital, Capital Mediacal University, Beijing, Beijing, 100000, China
URL: https://clinicaltrials.gov/show/NCT04340908