Effect of Parenteral Support on FibroScan in Short Bowel Syndrome

Rigshospitalet

Status: Not yet enrolling

Conditions: Intestinal Failure; Short Bowel Syndrome; Liver Diseases

Treatments: Diagnostic Test: Fibroscan

Study type: Observational

Funder types: Other

Identifiers

NCT07206004

H-25037724

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

20 participants in 1 patient group

Observational Cohort - patients with short bowel syndrome on parenteral support

Description:

Patients will receive their ususal parenteral support during the study

Treatment:

Diagnostic Test: Fibroscan