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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

148 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-15

Study Completion Date

2024-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Cardiac Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Preoperative blood glucose control

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.

Group Type EXPERIMENTAL

Preoperative blood glucose control

Intervention Type OTHER

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.

Preoperative blood glucose uncontrol

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Preoperative 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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No