Clinical trial NCT05621551: Dapagliflozin Therapy In Cardiac Surgery
Official title: Effects of Perioperative Dapagliflozin on Type 2 Diabetic Patients Undergoing Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Cardiac Surgery
Keywords: SGLT2 inhibitors
Cardiac Surgery
Diabetes Mellitus
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
First posted: 2022-11-18
Enrollment: 178
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years at screening
2. Scheduled for cardiac surgery
3. Diagnosis of Type 2 Diabetes
4. Provision of signed informed consent prior to any study specific procedures

Exclusion Criteria:

1. Emergency surgery and non-primary surgery
2. Moderate and severe dehydration; systolic pressure≤90mmHg; unstable haemodynamics
3. History of diabetic ketoacidosis; type 1 diabetes mellitus
4. Receiving therapy with an SGLT2 inhibitor within 4 weeks prior to enrolment
5. Known allergy or hypersensitivity to dapagliflozin or other SGLT-2 inhibitors
6. 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
7. Serious hepatic disease
8. Women who are pregnant, nursing, or who plan to become pregnant while in the trial
9. Currently enrolled in another investigational drug study, or less than 30 days

Primary outcomes:
measure: Hs-Troponin-I
timeFrame: within 2 days after surgery
Secondary outcomes:
measure: NT-proBNP
timeFrame: within 5 days after surgery
measure: Postoperative atrial fibrillation
timeFrame: within 5 days after surgery
measure: cardiac function
timeFrame: within 5 days after surgery
measure: Renal function
timeFrame: within 5 days after surgery
measure: Abnormal blood potassium concentration
timeFrame: within 5 days after surgery
measure: postoperative blood glucose level
timeFrame: within 5 days after surgery
measure: hs-C-reactive protein
timeFrame: within 5 days after surgery
measure: Hs-Troponin-I
timeFrame: within 5 days after surgery
Other outcomes:
measure: Safety Outcome
timeFrame: In-hospital time, an average of 2 weeks
measure: Major adverse cardiac cerebrovascular events
timeFrame: 30 days
measure: all-cause mortality
timeFrame: 30 days
measure: Incision infection
timeFrame: In-hospital time, an average of 2 weeks
measure: ICU readmission
timeFrame: In-hospital time, an average of 2 weeks
measure: ICU stay
timeFrame: Length of ICU stay after surgery，an average of 3 days
measure: Length of in-hospital time
timeFrame: In-hospital time, an average of 2 weeks
Locations:
city: Beijing
country: China
facility: 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
state: Beijing
Study officials:
affiliation: Fuwai Hospital, Chinese Academy of Medical Science
name: Zhe Zheng, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: