跳至主要内容
临床试验/CTRI/2024/06/069595
CTRI/2024/06/069595尚未招募2/3 期

Efficacy of noradrenaline vs dopamine in septic shock with late onset sepsis in Preterm babies.: open label randomised control trial

Government Medical CollegeAurangabad1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年7月8日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
80
试验地点
1
主要终点
Recovery from shock and duration of inotrope requirement .

研究概览

简要总结

Preterm neonates have lower levels of NE and dopamine immediately after birth than full-term neonates. While dopamine acts mainly through the release of NE from presynaptic vesicles, it’s effectiveness can succumb to the depletion of endogenous NE and an increased ratio of pulmonary and systemic artery pressure at high dopamine doses.Administration of dopamine at initial dosages lower than commonly recommended, followed by incremental increase in dose, may be associated with improved left ventricular performance with avoidance of undesirable tachycardia and arrhythmias.This evidence supports the trial of NE in preterm neonates with compromised hemodynamics.. Noradrenaline causes  significant improvement in fractional shortening and mean bold pressure.hemodynamics. Noradrenaline is a relatively safe and effective drug to use in the treatment of neonatal septic shock.Therefore to see the effect of norepinephrine in septic shock in preterm neonates and to compare those with dopamine study this will be caried out.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
3.00 Day(s) 至 28.00 Day(s)(—)
性别
All

入选标准

  • Neonates less than 37 weeks with suspected late onset sepsis.

排除标准

  • 1.Congenital structural heart disease 2.Neonate who is already on inotropes before eligibility.

结局指标

主要结局

Recovery from shock and duration of inotrope requirement .

时间窗: one year

time duaration for normalisation of clinical parameters and echocardiographic parameters.

时间窗: one year

次要结局

  • Mortality in both groups(one year)

研究者

发起方
Government Medical CollegeAurangabad
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Varsha Kanhu Deodhe

Government medical college, Aurangabad.

研究点 (1)

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