Comparison Of Effects Of Dexmedetomidine Vs Ivabradine On Mortality In Patients With Septic Shock A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 210
- 试验地点
- 1
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)(—)
- 性别
- All
入选标准
- •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.
排除标准
- •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.
研究者
Nikila Murugan
All India Institute Of Medical Sciences
