The Effect of Prophylactic Intravenous Amiodarone Administration on Reperfusion Ventricular Fibrillation in Patients With Left Ventricular Hypertrophy Undergoing Cardiopulmonary Bypass Surgery: Protocol for a Randomized Double-Blind Clinical Trial
Bibliographic record
Abstract
BACKGROUND: Ventricular fibrillation (VF) is a common arrhythmia that occurs after the release of aortic cross-clamp (ACC) in patients undergoing cardiopulmonary bypass (CPB) surgery. Repeated defibrillation and long duration of VF could increase myocardial injuries. In patients with left ventricular hypertrophy (LVH), VF is easier to occur and more difficult to be terminated. Amiodarone, known as class III antiarrhythmic agent, has the prominent properties of converting VF and restoring the sinus rhythm. Before ACC release, administration of amiodarone has been confirmed useful to reduce occurrence of VF. However, few studies are focused on the effect of amiodarone before ACC release on reducing VF in patients with LVH. OBJECTIVE: This study aimed at determining the efficacy of prophylactic intravenous amiodarone administration on reperfusion VF after release of ACC in patients with LVH undergoing CPB surgery. METHODS: This will be a prospective, randomized, double-blind, placebo-controlled trial. The trial will enroll 54 patients with LVH aged 18-75 years who will undergo CPB surgery. All eligible participants will be randomly allocated to either the amiodarone or placebo group by using the block randomization in a 1:1 ratio. The primary end point will be the incidence rate of VF 30 minutes after ACC release and be assessed using the Fisher exact test. All data will be analyzed in accordance with the intention-to-treat principle. RESULTS: The study began in August 2022, and the data collection will take place for the next 2 academic years. As of this writing, 21 participants have already been recruited for the study. CONCLUSIONS: With this trial, we are hoping to demonstrate that prophylactic infusion of amiodarone before ACC release could reduce the occurrence of reperfusion VF in patients with LVH. TRIAL REGISTRATION: ClinicalTrials.gov ChiCTR2000035057; https://www.chictr.org.cn/showprojen.aspx?proj=57145. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/40115.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.015 | 0.015 |
| Meta-epidemiology (narrow) | 0.005 | 0.002 |
| Meta-epidemiology (broad) | 0.011 | 0.004 |
| Bibliometrics | 0.002 | 0.002 |
| Science and technology studies | 0.002 | 0.003 |
| Scholarly communication | 0.003 | 0.002 |
| Open science | 0.002 | 0.001 |
| Research integrity | 0.007 | 0.005 |
| Insufficient payload (model declined to judge) | 0.036 | 0.006 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".