Cardiac Surgery
Conditions
Keywords
Cardiac Surgery, Atrial Fibrillation, Glycosylated Hemoglobin, Cox-Maze IV
Brief summary
In recent years, a growing body of research has shown that diabetes plays an important role in the development and recurrence of atrial fibrillation. How to achieve the treatment and prevention of recurrence of atrial fibrillation through appropriate blood glucose control is the current focus of clinical research. Glycosylated hemoglobin (HbA1c) is the product of a non-enzymatic reaction in which hemoglobin in red blood cells is combined with sugars in the serum (mainly glucose). The purpose of this multicenter, randomized controlled study is to compare the effects of different glycosylated hemoglobin control strategies on the effectiveness of Cox-Maze IV procedure for atrial fibrillation during cardiac surgery.
Interventions
OTHERPreoperative blood glucose control
Patients included in this group, under the guidance of endocrinologists, develop hypoglycemic strategies for patients, follow up and guide patients to take medication, review HbA1c levels after 6 weeks, perform surgical treatment if they meet preoperative HbA1c\<7.5%, continue hypoglycemic therapy if still above standards, and administer drugs according to the corresponding type of heart disease during this period.
Sponsors
Peking University People's Hospital
Peking University International Hospital
Beijing Huaxin Hospital
Kun Hua
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years * Elective cardiac surgery * A clear diagnosis of diabetes mellitus, and HbA1c ≥ 7.5% at the time of initial diagnosis and treatment * Preoperative combination of persistent or long-term persistent atrial fibrillation
Exclusion criteria
* Emergency surgery or limited-term surgery * Previous cardiac surgery * Left atrial diameter \> 65 mm * Serum creatine \> 1.8 mg/dL * Previous severe liver disease * Pregnant or planning to become pregnant * Have a malignant tumor
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of atrial fibrillation recurrence | one year post operative | Atrial fibrillation heart rate recorded on a 24-hour Holter electrocardiogram persisted for more than 30 seconds |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of atrial fibrillation recurrence | 6 months post operative | Atrial fibrillation heart rate recorded on a 24-hour Holter electrocardiogram persisted for more than 30 seconds |
| All-cause Mortality | one year post operative | All-cause mortality identified during one-year follow-up |
Countries
China
Contacts
Primary ContactKun Hua
Outcome results
None listed