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临床试验/NCT04928040
NCT04928040已完成不适用

Evaluation of Intracranial Pressure Change by Measuring Optic Nerve Sheath Diameter During Fluid Challenge

Ondokuz Mayıs University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年6月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
The change in intracranial pressure associated with the fluid challenge

研究概览

简要总结

Fluid challenge is frequently used in fluid management of critically ill patients. Assessing whether there is a preload reserve that can be used to increase the stroke volume by delivering a small amount of fluid in a short period of time. Optimization of fluid therapy is very important in intensive care patients. Inappropriate fluid therapy can cause significant morbidity and even mortality. Increased intracranial pressure is one of these important complications. In the present study, we planned to evaluate the effect of a fluid challenge on intracranial pressure by measuring the optic nerve sheath diameter (ONSD).

详细描述

The fluid challenge is a simple volume resuscitation evaluation method that provides an indication of the patient's likelihood of benefiting from an increase in the intravenous fluid volume. Both the fluid challenge and fluid responsiveness are evaluated by interpreting the change in hemodynamic parameters after 500 mL of crystalloid (or 250 mL of colloid) solution is infused over 10-15 min. This is done in an attempt to regulate the fluid therapy of hemodynamically unstable patients in order to prevent fluid overload. In the present study, we aim to investigate the effect of the fluid challenge maneuver on intracranial pressure in ICU patients with hemodynamic instability through measuring the optic nerve sheath diameter by ultrasonography.

Patients in the intensive care unit undergoing a fluid challenge were included in this prospective observational study. A fluid challenge is defined as a 500 mL crystalloid infusion administered over 10 min, and fluid responsiveness is defined as a subsequent increase in stroke volume of at least 15%. The ONSD and hemodynamic variables will be measured by ultrasonography before (T0), at the end (T1), and 30 min after the fluid challenge (T2). The primary outcome of the study is the change in intracranial pressure associated with the fluid challenge, and the secondary outcome is the relationship between fluid responsiveness and the change in ONSD.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with no known intracranial pathology.
  • Patients with systolic blood pressure < 90 mmHg
  • Patients with mean blood pressure < 65 mmHg
  • Patients with tachycardia (heart rate 100 beats/min)
  • Patients with mottled skin, oliguria (diuresis of less than 20 ml/hr or 0.5 ml/kg/hr for two hours), and acute renal failure.
  • Patients with arterial lactate concentration > 2 mmol/L

排除标准

  • Patients with known intracranial hypertension
  • Patients in the early postpartum period
  • Patients with severe mitral or aortic regurgitation
  • Patients with cardiac arrhythmia
  • Patients unable to be evaluated due to poor echogenicity

结局指标

主要结局

The change in intracranial pressure associated with the fluid challenge

时间窗: Before, at the end, and 30 min after the fluid challenge.

The change in intracranial pressure according to the optic nerve sheath diameter measurements.

次要结局

  • The relationship between fluid responsiveness and the change in optic nerve sheath diameter(Before, at the end, and 30 min after the fluid challenge.)

研究者

发起方
Ondokuz Mayıs University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ozgur Komurcu

Assistant professor

Ondokuz Mayıs University

研究点 (2)

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