Logo 1 Logo 2

Clinical Trial Details

Trial ID: L7359
Source ID: NCT05621551
Associated Drug: Dapagliflozin
Title: Dapagliflozin Therapy In Cardiac Surgery
Acronym:
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2|Cardiac Surgery
Interventions: DRUG: Dapagliflozin
Outcome Measures: Primary: Hs-Troponin-I, high sensitive cardiac troponin-I, within 2 days after surgery | Secondary: 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 | Other: Safety Outcome, Number of Adverse Events, Serious Adverse Events, Diabetic ketoacidosis, Severe hypoglycemic events, hypovolemia, urogenital tract infection, In-hospital time, an average of 2 weeks|Major adverse cardiac cerebrovascular events, Exploratory endpoints, 30 days|all-cause mortality, Exploratory endpoints, 30 days|Incision infection, Exploratory endpoints, In-hospital time, an average of 2 weeks|ICU readmission, Exploratory endpoints, In-hospital time, an average of 2 weeks|ICU stay, Exploratory endpoints, Length of ICU stay after surgery,an average of 3 days|Length of in-hospital time, Exploratory endpoints, In-hospital time, an average of 2 weeks
Sponsor/Collaborators: Sponsor: China National Center for Cardiovascular Diseases
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 178
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2022-11-11
Completion Date: 2023-07-01
Results First Posted:
Last Update Posted: 2022-11-18
Locations: 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, 100037, China
URL: https://clinicaltrials.gov/show/NCT05621551