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CTRI Number  CTRI/2024/11/076176 [Registered on: 04/11/2024] Trial Registered Prospectively
Last Modified On: 11/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Magnesium Sulphate in patients with new onset atrial fibrillation 
Scientific Title of Study   A Prospective Observational Study of Magnesium sulphate in Patients with New Onset Atrial Fibrillation 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  RISHWANTH RAJA P M 
Designation  POSTGRADUATE 
Affiliation  Sri Ramachandra Institute of Higher Education and Research  
Address  G Block 1st Floor Department of critical care medicine Sri Ramachandra Institute of Higher Education and Research No 1 Ramachandra Nagar Porur Chennai 600116 Tamil Nadu India

Thiruvallur
TAMIL NADU
600116
India 
Phone  8870767379  
Fax    
Email  rishwanthraja123@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Renuka M K 
Designation  PROFESSOR 
Affiliation  Sri Ramachandra Institute of Higher Education and Research  
Address  Sri Ramachandra Institute of Higher Education and Research No 1 Ramachandra Nagar Porur Chennai 600116 Tamil Nadu India

Thiruvallur
TAMIL NADU
600116
India 
Phone  8870767379  
Fax    
Email  hod.criticalcare@sriramachandra.edu.in  
 
Details of Contact Person
Public Query
 
Name  RISHWANTH RAJA P M 
Designation  POSTGRADUATE 
Affiliation  Sri Ramachandra Institute of Higher Education and Research  
Address  G Block 1st Floor Department of critical care medicine Sri Ramachandra Institute of Higher Education and Research No 1 Ramachandra Nagar Porur Chennai 600116 Tamil Nadu India

Thiruvallur
TAMIL NADU
600116
India 
Phone  8870767379  
Fax    
Email  rishwanthraja123@gmail.com  
 
Source of Monetary or Material Support  
G Block 1st Floor Department of critical care medicine Sri Ramachandra Institute of Higher Education and Research No 1 Ramachandra Nagar Porur Chennai 600116 Tamil Nadu India 
 
Primary Sponsor  
Name  Rishwanth Raja P M 
Address  G Block 1st Floor Department of critical care medicine Sri Ramachandra Institute of Higher Education and Research No 1 Ramachandra Nagar Porur Chennai 600116 Tamil Nadu India  
Type of Sponsor  Other [Rishwanth Raja P M] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rishwanth Raja P M  Sri Ramachandra Institute of Higher Education and Research  G Block 1st Floor Department of critical care medicine Sri Ramachandra Institute of Higher Education and Research No 1 Ramachandra Nagar Porur Chennai 600116 Tamil Nadu India
Thiruvallur
TAMIL NADU 
8870767379

rishwanthraja123@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Sri Ramachandra Institute of Higher Education and Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I489||Unspecified atrial fibrillation and atrial flutter,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1)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 
 
ExclusionCriteria 
Details  1)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.
4)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.
6)Severe valvular heart diseases.
7)Sick sinus syndrome, or rhythm other than Atrial fibrillation.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Conversion to normal sinus rhythm and rate control.  1 hour, 4 hours, 8 hours, 12 hours and 24 hours  
 
Secondary Outcome  
Outcome  TimePoints 
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  
 
Target Sample Size   Total Sample Size="79"
Sample Size from India="79" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/11/2024 
Date of Study Completion (India) 17/02/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

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.

 
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