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临床试验/NCT03671070
NCT03671070Unknown不适用

Role of Low Dose Epinephrine Boluses For Acute Hypotension in The Pediatrics ICU

Assiut University0 个研究点目标入组 50 人开始时间: 2019年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
50
主要终点
change of mean value of blood Pressure both systolic and diastolic according to age group

研究概览

简要总结

The Study evaluates the role of low dose epinephrine boluses in management of acute hypo-tension VS The Traditional management of acute hypo-tension.

Half of the participants suffering from acute hypo-tension will receive low dose epinephrine boluses (≤ 5 µg/kg/dose) and the other half will receive traditional management of shock

详细描述

Epinephrine, due to its alpha-1 and beta-adrenergic effects, is considered an important part of the management of children with hypo-tension. Epinephrine is typically used as a continuous infusion (0.02-0.5 μg/kg/min) for severe sustained hypo-tension and as a bolus (0.01 mg/kg, maximum dose = 1 mg) for bradycardia, asystole, or pulse-less arrest. There are, however, clinical conditions that may benefit from smaller doses of bolus epinephrine. For example, brief periods of hypo-tension during medical procedures, intermittent hemodynamic instability, and augmentation of low blood pressure in a pre-arrest condition. While a resuscitation (or code) dose of epinephrine would be inappropriate (as it would cause an unacceptable large increase in blood pressure and heart rate [HR]), a smaller dose may be particularly useful.

Low-dose bolus vasopressors have been used for decades by anaesthesiologists to prevent post-re-perfusion injury after solid organ transplant, control cerebral oxygenation during anaesthesia and manage acute hypo-tension during spinal surgery. Recently, use of bolus dose phenyl-ephrine has been described in the emergency department setting to augment blood pressure during periods of hypo-tension surrounding intubation. Finally, free open access medical publications have provided some insight into using bolus dose pressors for acute hypotensive episodes in adults. However, there is few published data describing the use of low-dose vasopressor boluses in children.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
1 Month 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients experiencing acute hypotensive episodes whether brief or during or after medical or surgical procedures

排除标准

  • Patients experiencing acute hypotensive episodes in arrest or pre-arrest situations

研究组 & 干预措施

Low dose Epinephrine boluses

Active Comparator

Patients suffering from acute hypo-tension will receive low dose IV epinephrine boluses ≤ 5 μg/kg/dose, 3 doses, within 3 hours

干预措施: Epinephrine (Drug)

Traditional management of shock

Placebo Comparator

Patients suffering from acute hypo-tension will be managed according to Traditional algorithm of Hypotension

干预措施: Traditional management of shock (Drug)

结局指标

主要结局

change of mean value of blood Pressure both systolic and diastolic according to age group

时间窗: within 1 Hours after injection

Assessment of patients' blood Pressure (both systolic and diastolic) will be at at the onset of acute hypo-tension and after every bolus of low dose epinephrine and pressure will be reassessed after 20 minutes from each bolus

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed E Eldaly

Principal Investigator

Assiut University

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