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Heart Rhythm Changes in Patients With Atrial Fibrillation After Cardiopulmonary Bypass: a Retrospective Analysis

Heart Rhythm Changes in Patients With Atrial Fibrillation After Cardiopulmonary Bypass: a Retrospective Analysis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06553391
Enrollment
106
Registered
2024-08-14
Start date
2024-08-01
Completion date
2025-05-30
Last updated
2025-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Keywords

atrial fibrillation, pharmacological cardioversion

Brief summary

The goal of this observational study is to learn about the lthe effect of the tetralogy of medication regimen on intraoperative cardioversion in patients with persistent AF. The main question it aims to answer is: Does the regimen improve the success rate of cardioversion in patients with persistent AF during cardiac surgery? The treatment protocol commences with the administration of amiodarone, followed by the administration of either all or a portion of the subsequent medications: aminophylline, ephedrine, and isoproterenol. This observational cohort study was conducted at the Chinese Academy of Medical Sciences Fuwai Shenzhen Hospital using the electronic medical record database, from August 1, 2024, to January 1, 2025. Patients diagnosed with atrial fibrillation who underwent cardiac surgery between June 1, 2020, and December 31, 2024, were included in the study.

Detailed description

Background: Most patients with atrial fibrillation (AF) continue to experience AF following cardiac surgery, which is not conducive to postoperative circulatory stability. Intraoperative active cardioversion has rarely studied due to uncertainty regarding the efficacy of pharmacological cardioversion and the recurrence rate of AF in patients with persistent AF. Objective: To assess the effect of the tetralogy of medication regimen on intraoperative cardioversion in patients with persistent AF. Methods: This observational cohort study was conducted at the Chinese Academy of Medical Sciences Fuwai Shenzhen Hospital using the electronic medical record database, from August 1, 2024, to January 1, 2025. Patients diagnosed with AF who underwent cardiac surgery between June 1, 2020, and December 31, 2024, were included in the study. These patients undergoing pharmacological cardioversion during surgery were matched with untreated patients in a 1:1 ratio based on age, sex, weight, diagnosis, beta blocker and digoxin usage, indicators from cardiac ultrasound and blood gas analysis. The treatment protocol commences with the administration of amiodarone, followed by the administration of either all or a portion of the subsequent medications: aminophylline, ephedrine, and isoproterenol. The choice between these drugs depends on the patient's blood pressure and heart rate. The incidence of cardioversion in patients who underwent the tetralogy of medication regimen approach was compared with that of untreated patients.

Interventions

DRUGThe tetralogy of medication regimen

During the rewarming process, the study group received an injection of 0.15g amiodarone via the extracorporeal circulation oxygenator. After heart re-beating: 1. If the heart rate is ≥70 beats per minute without specific therapy and in sinus rhythm or atrioventricular junctional rhythm, no special treatment is required. If the heart rate \<70 beats/min, intravenous injection of isoproterenol 2 ug may be administered. 2. In cases where there is sinus rhythm or atrioventricular junctional rhythm with a heart rate \<70 beats/min and perfusion pressure \<60mmHg, intravenous injection of ephedrine 10 mg + aminophylline 0.15 g should be given. 3. For patients with atrioventricular junctional rhythm or sinus rhythm and a heart rate \<70 beats/min but perfusion pressure ≥60mmHg, intravenous injections of aminophylline (0.15g) and ephedrine (10 mg) . 4. In cases where there is atrial fibrillation (AF), and the heart rate is ≥70 beats/min without special treatment.

Sponsors

Chinese Academy of Medical Sciences, Fuwai Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* ASA Ⅱ-Ⅲ, * Aged 18-70 years, * Who were scheduled for elective cardiac surgery under general anesthesia, * Who were diagnosed with atrial fibrillation by preoperative 12-lead electrocardiogram or 24-hour holter electrocardiogram.

Exclusion criteria

* Allergic to iodine, amiodarone or its excipients * Pulmonary fibrosis * Keratopathy or severe loss of vision or blindness * Patients with sick sinus syndrome, severe bradycardia (heart rate <50bpm), second- or higher-degree atrioventricular block * Preoperative intravenous infusion of amiodarone * Intraoperative radiofrequency ablation of atrial fibrillation * The patient is participating in another interventional clinical study.

Design outcomes

Primary

MeasureTime frameDescription
Sinus rhythmFrom the release of the aortic cross-clamp until 12 hours after surgeryElectrocardiogram monitoring

Secondary

MeasureTime frameDescription
Mean arterial pressureFrom the release of the aortic cross-clamp until the end of surgeryInvasive arterial blood pressure test
the use of temporary pacemakersFrom the release of the aortic cross-clamp until 12 hours after surgeryPostoperative record

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026