Outcomes Study of Glycosylated Hemoglobin Control in Cox-Maze IV During Cardiac Surgery

Kun Hua148 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

148

Conditions

Cardiac Surgery

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Rate of atrial fibrillation recurrence

Atrial fibrillation heart rate recorded on a 24-hour Holter electrocardiogram persisted for more than 30 seconds

Time frame: one year post operative

Secondary Outcomes

Rate of atrial fibrillation recurrence

Atrial fibrillation heart rate recorded on a 24-hour Holter electrocardiogram persisted for more than 30 seconds

Time frame: 6 months post operative

All-cause Mortality

All-cause mortality identified during one-year follow-up