| CTRI Number |
CTRI/2022/11/047351 [Registered on: 16/11/2022] Trial Registered Prospectively |
| Last Modified On: |
15/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
COMPARISON OF EFFICACY OF ORAL VERSUS INTRAVENOUS DILTIAZEM(DRUG USED TO CONTROL HEART RATE) IN PATIENTS WITH RAPID IRREGULAR HEART RATE |
|
Scientific Title of Study
|
COMPARISON OF EFFICACY OF INTRAVENOUS INFUSION VERSUS ORAL DILTIAZEM IN PATIENTS WITH ATRIAL FIBRILLATION AND RAPID VENTRICULAR RATE FOR RATE CONTROL:AN EXPLORATORY RANDOMISED CONTROL TRIAL |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
JEWEL RANI JOSE |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
AIIMS RISHIKESH |
| Address |
JEWEL RANI JOSE
JUNIOR RESIDENT
DEPARTMENT OF EMERGENCY MEDICINE
AIIMS RISHIKESH
Dehradun
UTTARANCHAL
249203
India |
| Phone |
09496868294 |
| Fax |
|
| Email |
jewka4229@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
BHARAT BHUSHAN BHARDWAJ |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
AIIMS RISHIKESH |
| Address |
BHARAT BHUSHAN BHARDWAJ
ASSISTANT PROFESSOR
DEPARTMENT OF EMERGENCY MEDICINE
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9889822922 |
| Fax |
|
| Email |
bharatbbhardwaj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
JEWEL RANI JOSE |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
AIIMS RISHIKESH |
| Address |
JEWEL RANI JOSE
JUNIOR RESIDENT
DEPARTMENT OF EMERGENCY MEDICINE
AIIMS RISHIKESH
Dehradun
UTTARANCHAL
249203
India |
| Phone |
09496868294 |
| Fax |
|
| Email |
jewka4229@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS RISHIKESH |
| Address |
AIIMS RISHIKESH
Virbhadra Road, Rishikesh. Uttarakhand- 249 203
INDIA |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| JEWEL RANI JOSE |
AIIMS RISHIKESH |
DEPARTMENT OF EMERGENCY MEDICINE
AIIMS RISHIKESH
Virbhadra Road, Rishikesh. Uttarakhand- 249 203
Dehradun
UTTARANCHAL |
09496868294
jewka4229@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE,AIILMS RISHIKESH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I480||Paroxysmal atrial fibrillation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Diltiazem |
Diltiazem immediate release tablet 60mg stat dose
|
| Comparator Agent |
Diltiazem |
Diltiazem intravenous infusion 5mg/Hr titrated upto 1.25mg/Hr every 15-60 mins to a maximum rate of 15mg/Hr |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Age >18yrs
2.Patients presenting to ED of AIIMS Rishikesh with Atrial Fibrillation (AF)with rapid ventricular rate (Ventricular rate >110/min) and having received initial diltiazem iv bolus (weight based).
|
|
| ExclusionCriteria |
| Details |
1.Hemodynamically unstable patients
a) Systolic BP <90mmHg
b) Acutely altered mental status
c) Signs of shock
d) Ischemic chest discomfort
e) Acute heart failure
2.Any patient requiring electrical cardioversion.
3.Patients diagnosed with acute myocardial infarction.
4.Patients already received another antiarrhythmic agent within 24 hours before inclusion in study.
5.Patients in whom oral drug cannot be administered.
6.Hepatic dysfunction
a) Decompensated chronic liver failure
b) Severe acute hepatitis
7.Patients diagnosed with pre-excitation syndromes.
8.Patients not consenting to be part of the study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. Achievement of rate control i.e ventricular rate 110/min at 4 hours after enrolment in the study. |
4 hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Need for additional intravenous (IV) boluses of diltiazem.
2. Need for switching from oral to iv infusion.
3. Need for another antiarrhythmic agent for rate control.
4. Need for vasopressor support.
5. Need for DC Cardioversion
6. Length of stay in the emergency department.
7. Length of in hospital stay.
8. Occurrence of any adverse effects.
9. Conversion to sinus rhythm.
|
4 hour |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
21/11/2022 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Atrial fibrillation(AF) is the most common arrythmia encountered and treated by emergency physicians. Symptomatic relief and ventricular rate control are the primary therapeutic objectives in emergency management of acute AF, which can be achieved by either rate or rhythm control. We intend to conduct a study comparing the routes of administration of diltiazem - a calcium channel blocker in treating AF. This study will also asses occurance of adverse effects ,length of hospital/ emergency stay, need for other alternatives to achieve rate control as secondary outcomes. The study would be helpful in choosing the appropriate route of administration which determines the length of hospital stay, resource utilisation and level of monitoring required in emergency department. |