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临床试验/CTRI/2024/11/076176
CTRI/2024/11/076176招募中不适用

A Prospective Observational Study of Magnesium sulphate in Patients with New Onset Atrial Fibrillation

Rishwanth Raja P M1 个研究点 分布在 1 个国家目标入组 79 人开始时间: 2024年11月10日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
79
试验地点
1
主要终点
Conversion to normal sinus rhythm and rate control.

研究概览

简要总结

All patients and their relatives will be informed about the hospital policy regarding the use of their medical records for scientific purposes upon admission. Informed consent will be obtained from the patients (those that were able to provide it) or from their relatives if the patients physical condition prevented them from signing it. Atrial fibrillation is   defined as irregular, chaotic atrial activity with no apparent P waves and irregular ventricular activity, with a ventricular rate consistently >110 beats/min lasting for at least 30 minutes. New-onset Atrial fibrillation is defined as newly developed Atrial fibrillation during the ICU stay in patients without a previous history of atrial tachyarrhythmias and antiarrhythmic drug use. The diagnosis will be confirmed by a 12-lead electrocardiogram  and 2D-Echo to rule out structural heart diseases and clots. Patients with a previous history of atrial tachyarrhythmias and those using specific antiarrhythmic drugs will be excluded. Identification, evaluation and treating underlying causes will be done simultaneously. The mean arterial pressure and heart rate just before and at the onset of Atrial fibrillation and subsequently at 1 hour, 4 hours, 8 hours, 12 hours and 24 hours will be recorded. DC Cardioversion will be done when the Atrial Fibrillation causes hemodynamic instability. Magnesium sulphate is given with a dose 4.5g as our standard dose over 20mins. Serum magnesium and serum potassium levels will be obtained in all patients priorly on admission and levels noted.  In case if there is no conversion to sinus rhythm or reduction of the ventricular rate to <110 beats/min within 30 minutes after the start of the magnesium sulphate bolus. According to our standard protocol we use rate and rhythm controlling drugs, the treating physician decides the drug, Amiodarone (loading dose 150 mg in 15 minutes, followed by another bolus of amiodarone of 150mg if not controlled, amiodarone infusion is initiated at 1mg/min for 6 hours and 0.5mg/minute for18hrs. The attending physician will determine when to discontinue the amiodarone infusion upon obtaining sinus rhythm. The rhythm and rate for both magnesium responders and non-responders each hour after the onset of atrial fibrillation will be noted. Other rate-controlling drugs like Betablocker-Metoprolol, Calcium channel-diltiazem and digoxin are also added depending on the treating physician. In the management of Atrial fibrillation in ICU, the objective is to rapidly decrease Ventricular rate with or without restoration of sinus rhythm. For most patients with new-onset Atrial fibrillation due to critical illness, the risks of anticoagulation seem to generally outweigh potential benefits.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • Age 18 years or more 2)New onset atrial fibrillation(within 48 hours) of presentation,persist for atleast 30mins,ventricular rate 120 beats per minute or more without evidence of volume depletion 3)Normal Hemodynamics of Systoilc BP greater than 100mmhg and diastolic BP greater than 60mmhg.

排除标准

  • Previous history of atrial tachyarrhythmias and antiarrhythmic drug use, 2)Permanent, Paroxysmal atrial fibrillation of unknown duration where also excluded, 3)Hemodynamic instability- a systolic blood pressure (SBP) of less than 90 mmHg and indicated for electrical cardioversion.
  • Patients will also be excluded if their Atrial fibrillation had a wide-complex ventricular response (potential Wolff-Parkinson-White preexcitation syndrome, 5)Chronic Kidney Disease.
  • Severe valvular heart diseases.
  • Sick sinus syndrome, or rhythm other than Atrial fibrillation.

结局指标

主要结局

Conversion to normal sinus rhythm and rate control.

时间窗: 1 hour, 4 hours, 8 hours, 12 hours and 24 hours

次要结局

  • Therapeutic response (referred to as resolution time), Differences in characteristics between magnesium responders and non-responders, To assess if there has been a reduction in the requirement for antiarrhythmic medications(1 hour, 4 hours, 8 hours, 12 hours and 24 hours)

研究者

发起方
Rishwanth Raja P M
申办方类型
Other [Rishwanth Raja P M]
责任方
Principal Investigator
主要研究者

RISHWANTH RAJA P M

Sri Ramachandra Institute of Higher Education and Research

研究点 (1)

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