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

Kun Hua

Status: Enrolling

Conditions: Cardiac Surgery

Treatments: Other: Preoperative blood glucose control

Study type: Interventional

Funder types: Other

Identifiers

NCT05374655

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Details and patient eligibility

About

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.

Enrollment: 148 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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148 participants in 2 patient groups

Preoperative blood glucose control

Experimental group

Description:

Under the guidance of endocrinologists, the patient's hypoglycemic strategy is formulated, follow-up guidance is guided by the patient to take the drug, the HbA1c level is reviewed after 6 weeks, the preoperative HbA1c \< 7.5% is performed surgically, and if it is still above the standard, the hypoglycemic therapy is continued, during which the patient is administered according to the corresponding heart disease type.

Treatment:

Other: Preoperative blood glucose control

Preoperative blood glucose uncontrol

No Intervention group

Description:

Patients included in this group ≥ 7.5% preoperative HbA1c and underwent surgery directly