跳至主要内容
临床试验/NCT07053163
NCT07053163已完成不适用

Role of Low Dose of Norepinephrine Administration Within 24-Hour Mortality in Traumatic Patient With Hemorrhagic Shock

Tanta University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年8月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Mortality

研究概览

简要总结

The aim of the work is to evaluate role of low dose of nor epinephrine administration in the early 24-hour period among traumatic patients and hemorrhagic shock. The primary outcome: evaluate mortality at first 24 hour. The secondary outcome : measure total fluid intake, observe renal functions and Hemodynamic changes.

详细描述

Uncontrolled hemorrhage remains the leading cause of preventable death among patients with trauma, despite considerable improvements in trauma care Trauma- induced hemorrhage and hypovolemia can trigger an increase neurohormonal response and hypotension is not explained by hypovolemia alone but is associated with sympathy inhibitory-induced vasodilation. Trauma was defined as any exposure to nonpenetrating or penetrating kinetic energy, collision, or deceleration, Patients were alive on admission with hemorrhagic shock, defined by prehospital or admission mean arterial blood pressure less than 65 mm Hg. Management of shock after trauma remains a clinical challenge, in particular if associated with active hemorrhage and vasopressors are part of the recommended therapeutic routinely used by clinicians in Europe . Historically, the importance of permissive hypotension and the restriction of crystalloid fluid volume before hemorrhage control has been confirmed with good outcomes in patients with penetrating trauma.

Vasopressors mimic the initial response to blood loss; improve venous return, coronary perfusion, and myocardial contractility. Generally, vasopressors are considered to have a negative impact on patient outcome in the management of hemorrhagic Shock, and the predominant strategy is based on permissive hypotension and low volume resuscitation.

vasopressor use in hemorrhagic Shock in humans. The use of vasopressors, such as norepinephrine for the hemodynamic management of hemorrhagic shock, may be considered in the early phase of resuscitation and is a common practice among several prehospital and hospital emergency teams in Europe. Where any surgical or interventional radiographic procedures for the immediate control of bleeding and early activation of massive transfusion protocol are always not available, the effects vasopressor administration for severe hemorrhagic shock following trauma is used to restore arterial pressure in hemorrhagic shock. Norepinephrine is a sympathomimetic agent with predominantly vasoconstrictive effects. Norepinephrine exerts both arterial and venous α-adrenergic stimulation.

研究设计

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

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients 18 -65 Years old.
  • Multiple organ injury.
  • Recent trauma within 1st 24 hour.
  • Mean arterial blood pressure <65 mmHg

排除标准

  • Cardiac arrest at admission.
  • Old trauma more than 24 hour.
  • Severe brain or spinal injury (because of different target blood pressures).
  • Death due to haemostatic failure within 6 hours of admission

研究组 & 干预措施

Crystalloid and blood as resuscitation

Experimental

Patients receive crystalloid and blood as resuscitation.

干预措施: Crystalloid and blood as resuscitation (Drug)

Crystalloid& blood and low dose of norepinephrine

Experimental

receive crystalloid, blood and low dose of norepinephrine.

干预措施: crystalloid, blood and low dose of norepinephrine (Drug)

结局指标

主要结局

Mortality

时间窗: at first 24 hour

次要结局

  • total fluid intake(at first 24 hour)

研究者

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

Radwa Gamal Said Abdeldayem

Resident

Tanta University

研究点 (1)

Loading locations...

相似试验