| CTRI Number |
CTRI/2010/091/002969 [Registered on: 01/02/2011] |
| Last Modified On: |
09/10/2014 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Randomized, Crossover Trial |
Public Title of Study
Modification(s)
|
Ivabradine in controlling elevated heart rate among sick patients |
Scientific Title of Study
Modification(s)
|
Ivabradine in controlling tachycardia among critically ill patients |
| Trial Acronym |
None |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr SHUBHANKER MITRA |
| Designation |
|
| Affiliation |
|
| Address |
Department of Medicine-Unit II Christian Medical College,
Ida Scudder Road
Vellore
TAMIL NADU
632004
India |
| Phone |
04162282031 |
| Fax |
|
| Email |
smitracmc@rediffmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Kurien thomas |
| Designation |
|
| Affiliation |
|
| Address |
Professor & Head Department of Medicine-Unit II Christian Medical College
Ida Scudder Road
Vellore
TAMIL NADU
632004
India |
| Phone |
04162282166 |
| Fax |
|
| Email |
kurien123@gmail.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Shubhanker Mitra |
| Designation |
|
| Affiliation |
|
| Address |
Department of Medicine-Unit II Christian Medical College
Ida Scudder Road
Vellore
TAMIL NADU
632004
India |
| Phone |
04162282166 |
| Fax |
|
| Email |
smitracmc@rediffmail.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Fluid Research Grant,
Christian Medical College,
Vellore. Tamilnadu |
|
Primary Sponsor
Modification(s)
|
| Name |
Fluid Research Grant Christian Medical CollegeVellore Tamilnadu |
| Address |
Christian Medical college
Vellore
Tamilnadu |
| Type of Sponsor |
Research institution and hospital |
|
Details of Secondary Sponsor
Modification(s)
|
|
Countries of Recruitment
Modification(s)
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr SHUBHANKER MITRA |
Christian Medical College, Vellore |
Department of Medicine Unit II Christian Medical College Ida Scudder Road-632004
Vellore
TAMIL NADU |
04162282031
smitracmc@rediffmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board, Christian Medical College Vellore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Sinus Tachycardia, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Ivabradine |
7.5 mg, Per-oral or via NG Tube, 2 doses at 12 hours apart |
| Comparator Agent |
Pantoprazole |
40 mg, Per-oral or via NG Tube, 2 doses at 12 hours apart. |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
a)Aged above 18 years
b)Sinus rhythm with heart rate above 120 bpm
c) 24 hours of admission to the ICU with a diagnosis of shock.
d)In case of patients admitted with Organophosphorus poisoning, they should have been off atropine for at least 48 hours.
|
|
| ExclusionCriteria |
| Details |
ICU Physician assessment
Sick sinus syndrome
Sinu-atrial block
Pacemaker-dependency
3rd degree AV block
Ongoing fluid/volume loss
On concomitant use of potent CYP3A4 inhibitors:
Azole antifungals (ketoconazole, itraconazole),
Clarithromycin , erythromycin, josamycin, telithromycin,
HIV protease inhibitors (nelfinavir, ritonavir)
|
|
Method of Generating Random Sequence
Modification(s)
|
Permuted block randomization, fixed |
Method of Concealment
Modification(s)
|
Pharmacy-controlled Randomization |
Blinding/Masking
Modification(s)
|
Participant, Investigator and Outcome Assessor Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Comparison of the mean heart rate between the treatment and control group 24 hours after the initiation of the treatment. |
24 hours |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
Hemodynamic parameters up to 24 hrs.
Blood pressure and Mean Arterial Pressure (mm of Hg)
Urine output (ml/ hour)
Estimated Glomerular Filtration Rate (eGFR)
Blood lactate levels
P:F ratio
Duration of ventilation days
Mortality |
24 hours |
|
Target Sample Size
Modification(s)
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 3/ Phase 4 |
Date of First Enrollment (India)
Modification(s)
|
16/01/2011 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
16/01/2011 |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Data analysis is in progress |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This will be a prospective, double blind randomized, cross-over, study to evaluate the ability of Ivabradine to reduce an elevated heart rate in critically ill patients admitted in MICU / MHDU with severe tachycardia. The primary outcome of this study is the proportion of patients with a reduction of heart rate by at least 20 beats per minute (bpm) within 1 day of observation. This trial will randomize 100 patients (men and women, aged above 18 years) admitted in MICU /MHDU with sinus tachycardia (sinus rhythm with HR above 140 bpm). Subjects will be randomized based on computer generated programme to either Ivabradine or placebo group. Subjects in Ivabradine group will receive 2 doses of Ivabradine 7.5 mgs oral/NG at 12 hours apart. Subjects in the placebo group will receive 2 doses of Pantocid 40 mg via NG / oral at 12 hour apart. The period of observation will be 24 hours during which the HR and hemodynamic outcomes will be recorded once in 2 hours. After 12 hours of wash out period the subjects will cross over to second treatment period wherein the participants who received the Ivabradine will be given placebo and those who received placebo will receive Ivabradine. The outcome of interest will again be recorded 2 hourly for 24 hours. In addition any sudden events occurring in rate, rhythm or blood pressure will be noted during the period of the study. |