| 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
|
|
|
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
|
|
|
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. |