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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

Comparison Of Effects Of Dexmedetomidine Vs Ivabradine On Mortality In Patients With Septic Shock A Randomized Controlled Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/01/101605
Enrollment
210
Registered
2026-01-19
Start date
Unknown
Completion date
Unknown
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I959- Hypotension, unspecified

Interventions

Intervention1: dexmeditomedine: Patients will receive dexmedetomidine at a fixed dose of 0.5 g/kg/hr as a continuous intravenous infusion for 72 hours. No loading dose will be administered Interventi

Sponsors

AIIMS JODHPUR
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
To compare the effect of dexmedetomidine or ivabradine on 28-day all-cause mortality in patients with septic shockTimepoint: 28 days

Secondary

MeasureTime frame
HR, MAP baseline, maximum & minimum value of HR, SBP, DBP, MAPTimepoint: 24h, 48h, 72h ;IL-6, CRP, ferritin Timepoint: 0h, 24h, 48h, 72h ;SOFA score Timepoint: 24hours;CRT & lactate clearance Timepoint: base line, 12h, 24h, 36h, 48h, 60h, 72h;Vasopressor requirement (VIS score)Timepoint: 0h 24h, 48h, 72h ;ECHO LVEF, LVOT VTI, IVC Timepoint: daily

Countries

India

Contacts

Public ContactBharat Paliwal

All India Institute Of Medical Sciences

docbpali@gmail.com9588089378

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026