Clinical Trials Directory

Trials / Not Yet Recruiting

Not Yet RecruitingNCT07206004

Effect of Parenteral Support on FibroScan in Short Bowel Syndrome

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

Status
Not Yet Recruiting
Phase
Study type
Observational
Enrollment
20 (estimated)
Sponsor
Rigshospitalet, Denmark · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTFibroscanFibroscan will be perfomed while the patient receives their usual parenteral support

Timeline

Start date
2026-02-01
Primary completion
2026-08-01
Completion
2027-08-01
First posted
2025-10-03
Last updated
2025-10-03

Locations

1 site across 1 country: Denmark

Source: ClinicalTrials.gov record NCT07206004. Inclusion in this directory is not an endorsement.