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CTRI Number  CTRI/2025/09/094562 [Registered on: 11/09/2025] Trial Registered Prospectively
Last Modified On: 10/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing Two Medications to Safely Lower High Heart Rate in Severe Infection: A Study of Ivabradine and Esmolol 
Scientific Title of Study   Effect of short-term targeted heart rate control with Ivabradine versus Esmolol in septic shock with refractory tachycardia: A randomised controlled trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr.Loveneesh Dagar 
Designation  Senior Resident  
Affiliation  Department of Anesthesiology Pain Medicine and Critical care AIIMS New Delhi 
Address  Department of Anesthesiology Pain Medicine and Critical care AIIMS Ansari Nagar New Delhi

South
DELHI
110029
India 
Phone  8447073012  
Fax    
Email  loveneesh1172014@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr.Ajisha Aravindan  
Designation  Associate Professor  
Affiliation  Department of Anesthesiology Pain Medicine and Critical care AIIMS New Delhi 
Address  Dept of Anesthesiology, Pain Medicine and Critical Care, Room 14, Porta Cabin, 4th Floor, Academic Block, AIIMS, Ansari Nagar South DELHI 110029 India

South
DELHI
110029
India 
Phone  9810597276  
Fax    
Email  ajishaa@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr.Loveneesh Dagar 
Designation  Senior Resident  
Affiliation  Department of Anesthesiology Pain Medicine and Critical care AIIMS New Delhi 
Address  Department of Anesthesiology Pain Medicine and Critical care AIIMS Ansari Nagar New Delhi

South
DELHI
110029
India 
Phone  8447073012  
Fax    
Email  loveneesh1172014@gmail.com  
 
Source of Monetary or Material Support  
AIIMS New Delhi 
 
Primary Sponsor  
Name  Department of Anesthesiology Pain Medicine and Critical Care 
Address  Department of Anesthesiology, Pain Medicine and Critical Care Room no 5011 ,5th floor Teaching block ,AIIMS Ansari Nagar ,New Delhi 110029 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Loveneesh Dagar  AB Block ,ICU, 8th floor , All India Institute of Medical Sciences, New Delhi , 110029  AB Block, ICU,8th floor ,AIIMS , New Delhi 110029
South
DELHI 		 8447073012

loveneesh1172014@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institute Ethics Committee AIIMS New Delhi  Submittted/Under Review 
Institute Ethics Committee AIIMS New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B950||Streptococcus, group A, as the cause of diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Enteral Ivabradine   Ivabradine is given enterally (orally or via Ryles tube) in a dose of 2.5 - 7.5mg 12 hourly.Ivabradine is ommited/stopped when heart rate is less than 70 bpm 
Comparator Agent  Intraveneous Esmolol   Esmolol is given Intravenously in a infusion dose of 50-200 mg/hour . Dose is adjusted every 30 minutes.Infusion stopped when heart rate is less than 70 bpm  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Adult patients with septic shock (Vasoactive Inotropic score 10 - 50) and sinus tachycardia with a heart rate of more than 110 bpm, after at least 12 hours of ICU admission and stabilization. 
 
ExclusionCriteria 
Details  VIS score more than 100
safety concerns with Enteral Ivabradine and negative inotropic effects of Esmolol  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Mean Vasoactive-Inotropic Score   recorded every 6 hours, up to 54 hours 
 
Secondary Outcome  
Outcome  TimePoints 
Mean heart rate   recorded at baseline and every 6 hours, up to 54 hours 
Percentage of time-points in which heart rate is within the target range   From 6 to 54 hrs  
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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 
Date of First Enrollment (India)   21/09/2025 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [ajishaa@gmail.com].

  6. For how long will this data be available start date provided 01-10-2025 and end date provided 31-10-2032?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary  

Sepsis accounts for high mortality in Intensive care unit. Hemodynamic alterations which occur as compensatory mechanism such as Tachycardia increases the mortality in sepsis. Therefore, heart rate control in sepsis improves the myocardial function by increasing diastolic filling time. Beta 1 receptor blockers such as Esmolol have been used in multiple studies to achieve heart rate control and use is associated with reduced vasopressor requirements and cardiac performance.

Another pharamacological agent Ivabradine has been investigated recently in couple of trials which have shown favourable heart rate control, reduced vasopressor requirements, improved macro and microcirculatory parameters in sepsis.

These two agents i.e Esmolol and Ivabradine have never been compared head to head. This study aims to compare the two agents in terms of safety and efficacy hypothesising that Ivabradine is non inferior to Esmolol.
 
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