Dapagliflozin Therapy In Cardiac Surgery

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05621551
• Other study ID #: 2021-1437
• Status: Recruiting
• Phase: Phase 4
• Start date: November 11, 2022
• Est. completion date: July 1, 2023

Study information

• Verified date: November 2022
• Source: China National Center for Cardiovascular Diseases
• Contact: Zhe Zheng, MD,PhD
• Phone: +86-010-88396051
• Email: zhengzhe[@]fuwai.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 178
• Est. completion date: July 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Surgery
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Dapagliflozin
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.

Locations

Country	Name	City	State
China	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

Sponsors (1)

Lead Sponsor	Collaborator
China National Center for Cardiovascular Diseases

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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
Other	Major adverse cardiac cerebrovascular events	Exploratory endpoints	30 days
Other	all-cause mortality	Exploratory endpoints	30 days
Other	Incision infection	Exploratory endpoints	In-hospital time, an average of 2 weeks
Other	ICU readmission	Exploratory endpoints	In-hospital time, an average of 2 weeks
Other	ICU stay	Exploratory endpoints	Length of ICU stay after surgery,an average of 3 days
Other	Length of in-hospital time	Exploratory endpoints	In-hospital time, an average of 2 weeks
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
Secondary	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
Secondary	cardiac function	Echocardiography is used to assess cardiac function	within 5 days after surgery
Secondary	Renal function	Change of creatinine values, need for renal replacement therapy	within 5 days after surgery
Secondary	Abnormal blood potassium concentration	blood potassium concentration<3.5mmol/L or >5.5mmol/L	within 5 days after surgery
Secondary	postoperative blood glucose level		within 5 days after surgery
Secondary	hs-C-reactive protein		within 5 days after surgery
Secondary	Hs-Troponin-I		within 5 days after surgery