| CTRI Number |
CTRI/2026/01/101605 [Registered on: 19/01/2026] Trial Registered Prospectively |
| Last Modified On: |
09/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
role of dexmeditomedine and ivabradine in patients with septic shock with tachycardia in addition to standard care to check the decrease in vasopressor requirement, inflammatory markers |
|
Scientific Title of Study
|
Comparison Of Effects Of Dexmedetomidine Vs Ivabradine On Mortality In Patients With Septic Shock A Randomized 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 |
Nikila Murugan |
| Designation |
Senior Resident |
| Affiliation |
All India Institute Of Medical Sciences |
| Address |
Department of Anaesthesiology and Criticalcare,
All India Institute Of Medical Sciences,
Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9444635100 |
| Fax |
|
| Email |
nikilamurugan1996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Bharat Paliwal |
| Designation |
Additional Professor |
| Affiliation |
All India Institute Of Medical Sciences |
| Address |
Department of Anaesthesiology and Criticalcare,
All India Institute Of Medical Sciences,
Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9588089378 |
| Fax |
|
| Email |
docbpali@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Bharat Paliwal |
| Designation |
Additional Professor |
| Affiliation |
All India Institute Of Medical Sciences |
| Address |
Department of Anaesthesiology and Criticalcare,
All India Institute Of Medical Sciences,
Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9588089378 |
| Fax |
|
| Email |
docbpali@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS JODHPUR |
| Address |
All India Institue Of Medical Sciences,
Basni,
Jodhpur 342005 |
| 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 |
| Nikila Murugan |
All India Institute of Medical Sciences |
Adult ICU, Department of Anaesthesiology and Critical care, AIIMS Jodhpur
Jodhpur
RAJASTHAN |
9444635100
nikilamurugan1996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| All India Institute of Medical Sciences - Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I959||Hypotension, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
dexmeditomedine |
Patients will receive dexmedetomidine at a fixed dose of 0.5 µg/kg/hr as a continuous intravenous infusion for 72 hours. No loading dose will be administered |
| Intervention |
ivabradine |
ivabradine - Group(GROUP-I) Patients will receive ivabradine 5 mg twice daily (BD) administered orally or via a nasogastric tube for 72 hours |
| Comparator Agent |
standard care group |
all patients will continue to receive standard care for septic shock, including antibiotics, vasopressors, and supportive organ therapy in accordance with Surviving Sepsis Campaign guidelines |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Age more than 18 years
Diagnosis of septic shock, as per Sepsis-3 definition
Onset of septic shock within the past 24 hours
Receiving norepinephrine as part of standard care
Persistent sinus tachycardia (HR more than 100bpm) despite initial resuscitation
Informed consent obtained from the patient or legally authorized representative
|
|
| ExclusionCriteria |
| Details |
Known hypersensitivity or contraindication to dexmedetomidine or ivabradine
Presence of high-grade AV block, sick sinus syndrome, or severe bradycardia (HR less than 60 bpm) without a functioning pacemaker
Acute coronary syndrome or decompensated heart failure within the past 7 days.
Baseline left ventricular ejection fraction (LVEF) less than 30percent
Severe hepatic impairment (Child-Pugh Class C).
Severe renal impairment(CrCl less than 15ml/min) prior to enrolment
Use of beta blockers, calcium channel blockers (verapamil/diltiazem), or other HR-lowering agents not safely discontinued
Pregnancy or lactation
Patients with do-not-resuscitate (DNR) status or expected death within 24 hours
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effect of dexmedetomidine or ivabradine on 28-day all-cause mortality in patients with septic shock |
28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
HR, MAP baseline, maximum & minimum value of HR, SBP, DBP, MAP |
24h, 48h, 72h
|
IL-6, CRP, ferritin
|
0h, 24h, 48h, 72h
|
SOFA score
|
24hours |
CRT & lactate clearance
|
base line, 12h, 24h, 36h, 48h, 60h, 72h |
| Vasopressor requirement (VIS score) |
0h 24h, 48h, 72h
|
ECHO – LVEF, LVOT VTI, IVC
|
daily |
|
|
Target Sample Size
|
Total Sample Size="210"
Sample Size from India="210"
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)
|
30/01/2026 |
| 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)
|
Open to Recruitment |
| 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
|
Sepsis, a life-threatening syndrome, is associated with autonomic dysregulation & elevated levels of catecholamines (noradrenaline/adrenaline), released from sympathetic nervous system. Although this adrenergic surge is initially adaptive, its persistence can exacerbate organ injury and eventual mortality. Rudiger & Singer gave therapeutic approaches aimed at reducing excessive adrenergic stimulation. Drugs implicated - Dexmedetomidine, an alpha 2 agonist, and Ivabradine a funny current channel inhibitor. Both agents have been used in septic shock for reducing sympathetic surge. However no study has compared effect of both these agents on 28 day mortality. |