Randomised comparative clinical study of effects of dexmetomidine infusion vs midazolam infusion on inflammatory biomarkers in patients with sepsis requring mechanical ventilation

DIKSHA CHOUDHARY1 个研究点分布在 1 个国家目标入组 60 人开始时间: 2023年5月15日最近更新: 2023年2月5日

试验速览

阶段: 1/2 期
状态: 尚未招募
发起方
入组人数: 60
试验地点: 1
主要终点: To compare the effect of Dexmetomidine infusion with Midazolam infusion on inflammatory markers like CRP, IL-6 and lactate levels.

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study is randomized , double blind parallel group single centre trial comparing effects of dexmetomidine and midazolam infusion on inflammatory biomarkers in patients with sepsis requiring mechanical ventilator 18 months in 60 patients. The primary outcome measures To compare the effect of Dexmetomidine infusion with Midazolam infusion on inflammatory markers like CRP, IL-6 and lactate levels.with secondary outcome

研究设计

研究类型: Interventional
分配方式: Random Number Table
盲法: Participant and Investigator Blinded

入排标准

年龄范围: 18.00 Year(s) 至 80.00 Year(s)（—）
性别: All

入选标准

•In sepsis (patient fulfilling SIRS criteria of sepsis).
•Patient on mechanical ventilation.
•Patient having sequential organ failure assessment (SOFA) score of 2 or more.

排除标准

•1.Patients with history of severe cardiac or pulmonary disease, poorly controlled hypertension. 2.Known hypersensitivity to study drugs or using any drug that modifies pain perception. 3.Refusal to participate 4.Have unpaced second or third degree heart block 5.Have uncontrolled hypotension 6.Have acute cerebrovascular conditions 7.Concurrently using other alpha-2 agonists, eg, clonidine 8.Cautions for the following patients who are:.
•a.Are at risk of exaggerated cardiovascular response, e.g., hypovolaemia b.Have spinal cord injury c.Have severe left ventricular systolic dysfunction d.Are pregnant e.Breast-feeding f.Have seizures disorder.

结局指标

主要结局

To compare the effect of Dexmetomidine infusion with Midazolam infusion on inflammatory markers like CRP, IL-6 and lactate levels.

时间窗: as per study protocol CRP, IL-6 and Lactate levels to be done on day 0 ,2 and 5 of ICU admission and on mechanical ventilation.

次要结局

To compare the effect of Dexmetomidine infusion with Midazolam infusion on number of days on mechanical ventilation, length of ICU stays, nutrition (by albumin levels) platelet count and INR (coagulopathy).(Adverse effects if any)

研究者

发起方

DIKSHA CHOUDHARY

申办方类型

Other [self]

研究点 (1)

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