| CTRI Number |
CTRI/2020/04/024511 [Registered on: 08/04/2020] Trial Registered Prospectively |
| Last Modified On: |
08/04/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Use of amiodarone in patient with altered heart rhythm and evaluating re-emergence of altered heart rate after heart surgery. |
|
Scientific Title of Study
|
Efficacy of amiodarone in patient with pre-existing atrial fibrillation and evaluating re-emergence of atrial fibrillation after aortic cross-clamp release in open heart surgery. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ARIN CHOUDHURY |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
VMMC AND SAFDARDUNG HOSPITAL |
| Address |
DEPARTMENT OF CARDIAC ANAESTHESIA,
VMMC AND SAFDARJUBG HOSPITAL
ANSARI NAGAR,
NEWDELHI
ANSARI NAGAR,
NEWDELHI 110029
South
DELHI
110029
India |
| Phone |
7839756566 |
| Fax |
|
| Email |
arinchoudhury@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
ARIN CHOUDHURY |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
VMMC AND SAFDARDUNG HOSPITAL |
| Address |
DEPARTMENT OF CARDIAC ANAESTHESIA,
ANSARI NAGAR,
NEWDELHI
ANSARI NAGAR,
NEWDELHI 110029
South
DELHI
110029
India |
| Phone |
7839756566 |
| Fax |
|
| Email |
arinchoudhury@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ARIN CHOUDHURY |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
VMMC AND SAFDARDUNG HOSPITAL |
| Address |
DEPARTMENT OF CARDIAC ANAESTHESIA,
ANSARI NAGAR,
NEWDELHI
ANSARI NAGAR,
NEWDELHI 110029
South
DELHI
110029
India |
| Phone |
7839756566 |
| Fax |
|
| Email |
arinchoudhury@gmail.com |
|
|
Source of Monetary or Material Support
|
| GOVERMENT MEDICAL COLLEGE |
|
|
Primary Sponsor
|
| Name |
VMMC AND SAFDARJUNG HOSPITAL |
| Address |
ANSARI NAGAR
NEWDELHI |
| Type of Sponsor |
Government medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| ARIN CHOUDHURY |
room no 216,ssb ,department of ctvs, |
VMMC AND SAFDARJUNG HOSPITALANSARI NAGAR
NEWDELHI
South
DELHI |
7838756566
arinchoudhury@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| vmmc |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I083||Combined rheumatic disorders of mitral, aortic and tricuspid valves, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
100ml Injection saline given |
1mg/kg Injection saline given along with cardioplegia during cardiopulmonary bypass after cross clamp application study end after cross clamp release |
| Intervention |
1mg/kg Injection Amiadarone |
1mg/kg Injection Amiadarone givenalong with cardioplegia during cardiopulmonary bypass after cross clamp application study end after cross clamp release |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
All adult patient with valvular heart surgery/cabg with atrial fibrillation. |
|
| ExclusionCriteria |
| Details |
Contraindications to amiodarone (sick sinus syndrome, atrioventricular conduction abnormalities, thyroid disease, interstitial lung disorders, renal or liver disease)
b) Need of concomitant cardiac surgical procedure
c)Emergency operation
d)Pretreatment with digoxin or amiodarone .
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 To investigate whether prophylactic amiodarone infusion prevents re-emergent of atrial fibrillation after aortic cross-clamp removed in patients with atrial fibrillation undergoing open cardiac surgery.
3.2To study the hemodynamic response of amiadarone after clamp off.
3.3Ease of separation from cardiopulmonary bypass.
|
Immediately after aortic cross-clamp release and end of surgery
|
|
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Secondary Outcome
|
| Outcome |
TimePoints |
.To study the hemodynamic response of amiadarone after clamp off.
.Ease of separation from cardiopulmonary bypass
|
END OF BYPASS TILL DISCHARGE FROM ICU |
|
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Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
09/04/2020 |
| 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="10"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
as atrial fibrillation is the major event in cardiac surgery which lead to hemodynamic instability so this trial will help to recude the atrial fibrilation in cardiac patient |