Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-24 @ 11:38 PM
NCT ID:
NCT05621551
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥ 18 years at screening
2. Scheduled for cardiac surgery (on-pump coronary artery bypass grafting, aortic valve replacement, or a combination of both)
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05621551
Study Brief:
Protocol Section:
NCT05621551