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Completed

NCT Number: NCT05621551

Dapagliflozin Therapy In Cardiac Surgery

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

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Key information

Conditions

Diabetes Mellitus, Type 2 Cardiac Surgery Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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 Municipality, 100037, China

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years at screening
  • Scheduled for cardiac surgery (on-pump coronary artery bypass grafting, aortic valve replacement, or a combination of both)
  • Diagnosis of Type 2 Diabetes
  • Provision of signed informed consent prior to any study specific procedures

Exclusion criteria

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

Treatment and study plan

Dapagliflozin

Drug

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.

Primary outcomes

  1. Hs-Troponin-I

    Time frame: within 2 days after surgery

    high sensitive cardiac troponin-I

Secondary outcomes

  1. Renal function

    Time frame: within 5 days after surgery

    Acute kidney injury determined by creatinine changes and the need for renal replacement therapy, along with creatinine changes and the need for renal replacement therapy themselves.

  2. NT-proBNP

    Time frame: within 5 days after surgery

    N-terminal prohormone of brain natriuretic peptide

  3. Postoperative atrial fibrillation

    Time frame: within 5 days after surgery

    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

  4. Perioperative myocardial infarction

    Time frame: In-hospital time, an average of 2 weeks

    Perioperative myocardial infarction was defined as an elevation in cardiac troponin accompanied by evidence of ischemia from ECG, angiographic, or imaging findings.

  5. cardiac systolic function

    Time frame: within 5 days after surgery

    Improvement in either left ventricular ejection fraction or left ventricular end-systolic volume, as measured by echocardiography.

  6. cardiac diastolic function

    Time frame: within 5 days after surgery

    Improvement in either E/e' ratio or left ventricular end-diastolic volume, as measured by echocardiography.

  7. Abnormal blood potassium concentration

    Time frame: within 5 days after surgery

    blood potassium concentration<3.5mmol/L or >5.5mmol/L

  8. postoperative blood glucose level

    Time frame: within 5 days after surgery

  9. Inflammatory biomarkers

    Time frame: within 5 days after surgery

    high-sensitivity C-reactive protein, interleukin-1β, interleukin-6, interleukin-8, and tumor necrosis factor-α

  10. Hs-Troponin-I

    Time frame: within 5 days after surgery

  11. ICU stay

    Time frame: an average of 3 days

    ICU Stay was defined as the duration (in days) of initial postoperative stay in the intensive care unit following cardiac surgery.

  12. Length of in-hospital time

    Time frame: an average of 2 weeks

    Length of in-hospital time was defined as the total number of days from the date of surgery to the date of hospital discharge.

Other outcomes

  1. Safety Outcome

    Time frame: In-hospital time, an average of 2 weeks

    Diabetic ketoacidosis, severe hypoglycemic events, hypovolemia, urogenital tract infection, Incision infection and serious adverse events

  2. ICU readmission

    Time frame: In-hospital time, an average of 2 weeks

    ICU readmission was defined as any unplanned readmission to the intensive care unit during the index hospitalization after the initial ICU discharge, regardless of cause.

  3. Major adverse cardiac cerebrovascular events and its individual components

    Time frame: 30 days

    Major adverse cardiac cerebrovascular events composite includes all-cause mortality, myocardial infarction, stroke, and reoperation

Sponsors and collaborators

Lead sponsor

China National Center for Cardiovascular Diseases

Other Gov

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Nov 18, 2022
Registry last updated
Jul 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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