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临床试验/NCT06440772
NCT06440772已完成不适用

Assessing Fluid Intolerance Using Portal Vein Pulsatility Index Post-Passive Leg Raising Test in Fluid Responders: A Prospective Cohort Study

Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年5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
已完成
发起方
入组人数
50
试验地点
1
主要终点
Fluid Intolerance

研究概览

简要总结

This study uses the portal vein pulsatility index (PVPI) to assess fluid intolerance amongst fluid responders.

详细描述

This prospective observational study aims to use the portal vein pulsatility index (PVPI) to assess fluid intolerance in fluid responders. The investigators will enroll mechanically ventilated postoperative adult patients within 6 hours of ICU admission after cardiac surgery. Patients will undergo a Passive Leg Raising (PLR) test and Left Ventricular Outflow Tract (LVOT) recording using transthoracic echocardiography. The main objective is to predict fluid intolerance after a fluid challenge of 7 ml/kg Ringer Lactate over 10 minutes in initially tolerant fluid responders.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Informed consent.
  • Mechanically ventilated patients within 6 hours after ICU admission following surgery who are considered for fluid administration to optimize haemodynamics.
  • Sinus rhythm.

排除标准

  • A condition known to interfere with portal vein flow assessment or interpretation (liver cirrhosis or chronic hepatic disease, suprahepatic or portal vein thrombosis).
  • Any mechanical circulatory support.
  • Cardiac transplant.
  • Poor transthoracic echocardiographic window.

研究组 & 干预措施

Tolerant Fluid Responders

Patients who are both responsive and tolerant to fluid.

干预措施: Ringer's Lactate Crystalloid Solutions (Drug)

结局指标

主要结局

Fluid Intolerance

时间窗: 10 minutes after 7 ml/kg Ringer's Lactate

A portal vein pulsatility index greater than 50%, calculated as (Vmax - Vmin) / Vmax, with no upper limit and 0% as the minimum limit. Higher values indicate worse outcomes. Ultrasonographic portal spectral waveform was used to measure Vmax and Vmin.

次要结局

未报告次要终点

研究者

发起方
Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu
申办方类型
Other
责任方
Principal Investigator
主要研究者

Balan Ion Cosmin

Principal Investigator

Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu

研究点 (1)

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