| CTRI Number |
CTRI/2023/12/060747 [Registered on: 26/12/2023] Trial Registered Prospectively |
| Last Modified On: |
22/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Amiodarone loading dose in increased heart rate patients |
|
Scientific Title of Study
|
Impact of loading dose of amiodarone in tachyarrythmia patients |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dhulipalla ujwal teja |
| Designation |
DM cardiology registrar |
| Affiliation |
kasturba medical college, manipal |
| Address |
Department of cardiology,kasturba medical college, manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9160602682 |
| Fax |
|
| Email |
ujteja@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mukund APrabhu |
| Designation |
Associate professor |
| Affiliation |
kasturba medical college,manipal |
| Address |
Department of cardiology,kasturba medical college,manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9895137146 |
| Fax |
|
| Email |
mukundaprabhu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mukund APrabhu |
| Designation |
Associate professor |
| Affiliation |
kasturba medical college,manipal |
| Address |
Department of cardiology,kasturba medical college,manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9895137146 |
| Fax |
|
| Email |
mukundaprabhu@gmail.com |
|
|
Source of Monetary or Material Support
|
| kasturba medical college,manipal |
|
|
Primary Sponsor
|
| Name |
Dhulipalla ujwal teja |
| Address |
Department of Cardiology, KMC Manipal |
| Type of Sponsor |
Other [self] |
|
|
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 |
| DrDhulipalla ujwal teja |
kasturba medical college |
s1 icu,imcu department of cardiology,kasturba medical college,manipal
Udupi
KARNATAKA |
9160602682
ujteja@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I499||Cardiac arrhythmia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
a) Age more than 18 years
b) Inpatients admitting with any cause requiring loading dose of amiodarone |
|
| ExclusionCriteria |
| Details |
a) Pregnancy,
b) Age less than 18 years
c) Not giving consent for study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
ecg changes
proarrythmic events |
0 hour,1 hour,6 hour,24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| hemodynamic changes |
0 hour,1 hour,6 hour,24 hours |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/12/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Patients who are admitted in cardiology and icu wards of kmc manipal and given loading dose of amiodarone for any tachyarrythmia are recruited in this study after screening of inclusion and exclusion criteria patients are included in this study who are willing to give informed consent.Patients are monitored after the loading dose of amiodarone. their bp is monitored with help of bp machine at 0 hour,1 hour, 6 hour and 24 hours and their Ecg is monitored for any proarrythmic events or any Ecg abnormalities at 0 hour,1 hour,6 hour and 24 hours |