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临床试验/NCT06311903
NCT06311903招募中不适用

Is Low Dose Norepinephrine Effective in Preperiod of Hypotensive Resuscitation in Hemorrhagic Shock?

Tanta University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年12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
状态
招募中
入组人数
200
试验地点
1
主要终点
24 hours mortality

研究概览

简要总结

The aim of this work was to investigate the effects of low dose of norepinephrine in preperiod of hypotensive resuscitation in hemorrhagic shock.

详细描述

Hemorrhagic shock is one of the leading causes of death following trauma. New fluid resuscitation concepts, including hypotensive, hypothermic, and delayed resuscitation for uncontrolled hemorrhagic shock, have been put forward and obtained a good effect both in clinical and laboratory parameters. The 2019 European guideline on the management of major bleeding and coagulopathy following trauma recommends the use of norepinephrine (NE) for maintaining target arterial blood pressure in patients with life-threatening hypotension. NE has potent α-adrenergic receptor activation activity, which can stimulate α-1 adrenergic receptors on peripheral vascular smooth muscles. High-dose NE may result in excessive arteriolar vasoconstriction which subsequently leads to the disorder of microcirculation and tissue hypoxia.

研究设计

研究类型
Interventional
分配方式
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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 18 years old.
  • Both sexes.
  • Patients with hemorrhagic shock

排除标准

  • Patients with cardiac arrest at admission.
  • Severe brain.
  • Spinal injury (because of different target blood pressures).
  • Death due to hemostatic failure within 6 h of admission.
  • Pregnancy.

研究组 & 干预措施

Group I

Experimental

Patients were received resuscitative fluid [administered at beginning with the arrival of the patient in the emergency department (mean blood pressure >70 mmHg)] followed by low dose of norepinephrine (NE) (0.05-0.2 μg/kg/min).

干预措施: Low dose of Norepinephrine (NE) (Drug)

Group II

Experimental

patients were received resuscitative fluid. If there were no response to treatment to resuscitative fluid, they received norepinephrine (NE) gradually till reach high dose (≥0.3 μg/kg/min).

干预措施: High dose of Norepinephrine (NE) (Drug)

结局指标

主要结局

24 hours mortality

时间窗: 24 hours after intervention

24 hours mortality will be measured.

次要结局

  • 28 day mortality(28 days after intervention)
  • Incidence of acute kidney injury(24 hours after intervention)
  • Length of intensive care unit stay(28 days after intervention)
  • Length of hospital stay(28 days after intervention)

研究者

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

Rabab Mohamed Mohamed Mohamed

Assistant Professor of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Tanta University

研究点 (1)

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