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临床试验/NCT06940258
NCT06940258尚未招募不适用

Efficacy of Caval Aorta Index for Fluid Optimization in Critically Ill Patients With Traumatic Brain Injury

Mansoura University0 个研究点目标入组 92 人开始时间: 2025年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
92
主要终点
fluid balance

研究概览

简要总结

Traumatic brain injury is a leading cause of death and disability in trauma patients. As the primary injury cannot be reversed; management strategies must focus on preventing secondary injury by avoiding hypotension and hypoxia besides, maintaining appropriate cerebral perfusion pressure, which is a surrogate for cerebral blood flow.

详细描述

The caval aorta index is an ultrasound element, relatively new, used to assess volume status. Technically, the sonographic assessment of the inferior vena cava /aorta diameter ratio is an easy test to perform and can be performed effectively by doctors who are not experienced in the field of sonography (Kusumastuti et al .2021).

In this study; the caval aorta index will be used to guide fluid dosage in critically ill patients with traumatic brain injury.

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
Double (Participant, Investigator)

盲法说明

A vascular US expert will read the number contained in computer generated randomization software and determine group assignments. Daily; he will be responsible on prescribing of the required fluid.

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Traumatic brain injury diagnosed by computed tomography scan Glasgow coma score ≥ 4

排除标准

  • •Inability to get consent. Pregnant and lactating women Traumatic subarachnoid hemorrhage Spinal cord injury Increased intra-abdominal pressure Abdominal aortic aneurysm Inferior vena cava (IVC) thrombus Portal hypertension Acute corpulmonale Congestive heart failure chronic hemodialysis Surgical intervention other than neurological one within the first 7 days Mechanical ventilation need during first 7 days Cardiac arrest during the first 7 days

研究组 & 干预措施

Control group

Other

干预措施: control group (Other)

ultrasound-guided caval-aorta index group

Experimental

干预措施: ultrasound measurement of caval aorta index (Procedure)

结局指标

主要结局

fluid balance

时间窗: after 96 hours from the admission

the difference between fluid input and fluid loss

次要结局

  • Central capillary refill(Daily for 7 days)
  • Central Venous Pressure (CVP) measurements(Daily every 6 hours for 7 days)
  • Frequency and duration of hypotension(within first 7 days)
  • Glasgow Coma Scale(daily within first 7 days)
  • incidence of pulmonary edema(Daily within first 7 days)
  • Urine output(Daily for 7 weeks)

研究者

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

maha abou-zeid

Assistant Professor of Anesthesia and Surgical Intensive Care

Mansoura University

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