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临床试验/NCT04686344
NCT04686344已完成早期 1 期

Sonography of the Optic Nerve Sheath Diameter for Comparison Between the Effects of Continuous Infusion of 3%Hypertonic Saline With Intermittent Boluses Versus in Patients With Traumatic Brain Injury.

Cairo University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年12月21日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
已完成
入组人数
50
试验地点
2
主要终点
Diameter of Optic nerve sheath

研究概览

简要总结

Elevated intracranial pressure (ICP) is one of the most common symptoms encountered in a variety of traumatic injuries and diseases. Any tissue swelling within the rigid confines of the skull results in increased ICP, which may lead to life-threatening structural alterations in the brain or cerebral blood flow, thus causing oxygen deprivation and ischemia in the brain.

Methods for ICP monitoring can be divided into invasive and noninvasive approaches. In fluid-based systems, external ventricular drainage (EVD) has been considered the gold standard.

Clinicians have found several noninvasive methods that can be used as surrogates for invasive methods for ICP measurement. The optic nerve, as part of the central nervous system, is wrapped by the dural sheath. The optic nerve sheath (ONS) is the continuation of the subarachnoid space at the optic nerve, and its tissues are connected with the subarachnoid space. Thus, an increase in ICP results in a corresponding elevation of the ONS diameter (ONSD).

Hypertonic solutions such as mannitol and hypertonic saline (HTS) are recommended early in the management of ICH after severe TBI . They provide therapeutic benefit along with a wide therapeutic margin. The most recent BTF guidelines stated "although hyperosmolar therapy may lower intracranial pressure, there was insufficient evidence about effects on clinical outcomes to support a specific recommendation, or to support use of any specific hyperosmolar agent".

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
Single (Participant)

入排标准

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

入选标准

  • Patients who having Isolated traumatized brain injury (not for surgical intervention)
  • Both genders.
  • Age ≥ 18 and ≤ 60Years.
  • Physical status ASA I - III.
  • Cut off value for optic nerve sheath diameter (ONSD) as 5.5 mm to diagnose increase in ICP> 20 mm Hg.
  • Exclusion criteria
  • Patients' first-degree relatives' refusal to sign the consent.
  • GCS (Glasgow coma score) >12 or GCS of
  • Contraindication to hypertonic saline: pregnancy, coagulopathy and cardiac dysfunction.
  • Spinal cord injury, orbital injury, optic nerve injury and optic neuritis.
  • Multi organ affection.
  • Serum Na level ≥ 150 mmol/L at admission to ICU.
  • Hypotension requiring vasopressors to maintain MAP above 60 mmHg.

排除标准

  • 未提供

研究组 & 干预措施

Hypertonic saline continuous infusion Group

Active Comparator

will receive Hypertonic saline continuous infusion

干预措施: continuous infusion of Hypertonic saline (Drug)

Hypertonic saline intermittent boluses Group

Active Comparator

will receive Hypertonic saline intermittent boluses for 48 hours

干预措施: intermittent boluses of Hypertonic saline (Drug)

结局指标

主要结局

Diameter of Optic nerve sheath

时间窗: UP TO 48 HOURS

assessment tool for Intracranial pressure

次要结局

  • intracranial pressure(up to 72 hours)
  • level of Conscious(UP TO 30 DAY)

研究者

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

Amr Samir Wahdan

Lecturer of Anesthesia, Pain management and Surgical ICU

Cairo University

研究点 (2)

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