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临床试验/NCT07206004
NCT07206004尚未招募不适用

Effect of Parenteral Nutrition/Fluids on FibroScan Results in Patients With Short Bowel Syndrome

Rigshospitalet, Denmark1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2026年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
20
试验地点
1
主要终点
Fibroscran

研究概览

简要总结

Home Parenteral Support (HPS) is a life-sustaining treatment for patients with short bowel syndrome and intestinal failure. This study aims to investigate how administration of parenteral support affects FibroScan results in order to determine optimal timing of liver assessment in this patient population.

详细描述

The objective of this study is to investigate the applicability and accuracy of FibroScan in assessing liver status among patients with short bowel syndrome and intestinal failure, both before and after administration of PS, by assessing the immediate effect of PS administration on FibroScan results in patients with short bowel syndrome. This is of particular importance since the timing of FibroScan relative to PS administration and infusion volume is presumed to influence the results, and thereby potentially the interpretation of hepatic status.By understanding how parenteral support influences FibroScan measurements, we aim to optimize the use of this non-invasive technique for monitoring liver status in patients with intestinal failure, thereby defining the optimal timing of scanning in relation to PS administration. This could potentially enable earlier detection of hepatic complications and thereby improve the long-term prognosis for these patients.

Once included, participants must fast and abstain from fluids for 3 hours prior to the examination. Measurements will consist of a FibroScan, blood pressure, body weight, and bioimpedance analysis.

Measurements will be performed:

  • Immediately before initiation of PS
  • Two hours after initiation of PS
  • Immediately after disconnection of PS
  • Two hours after completion of PS Participants will collect urine from 0 to 14 hours. Spot urine sodium will be analyzed at 0 hours and 14 hours. Urine volume will be measured and then discarded. The standard infusion time for PS is set at 12 hours overnight.

研究设计

研究类型
Observational
观察模型
Case Only
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

  • Adult patients (≥18 years) with short bowel syndrome with capacity to give consent
  • Patients receiving regular PS (≥4 days/week and ≥10 liters/week)
  • Stable clinical condition

排除标准

  • Known liver cirrhosis
  • Active infection, severe dehydration, or electrolyte disturbances
  • Pregnancy
  • Receiving IV fluids or medications on study day
  • Tapered infusion rate prior to disconnection

结局指标

主要结局

Fibroscran

时间窗: 14 hours

Change in transient elastography (FibroScan) values before, during, and after parenteral support

次要结局

  • CAP score(14 hours)
  • Correlation of Fibroscan and PS(14 hours)
  • Correlation of Fibroscan and other factors(14 hours)

研究者

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

Jessica Ramsing Wentworth

MD

Rigshospitalet, Denmark

研究点 (1)

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