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CompletedNCT06181474MELDESASUpdated May 4, 2025

MELD ESAS Evolution: Assessment of the Symptomatic Burden of Patients With Advanced Chronic Liver Disease

An observational study in Palliative Care and End Stage Liver DIsease, sponsored by Unidade Local de Saúde de Matosinhos, EPE. Completed at 1 site in Portugal. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-04.

Sponsored by Unidade Local de Saúde de Matosinhos, EPE · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
44
Ages
18 Years and older
Sex
All
01

Study summary

The goal of this observational study is to understand if there is a correlation between the evolution of MELD-Na and symptomatic burden of patients with advanced chronic liver disease.

All patients with chronic liver disease will be invited to participate in the study. Patients will be followed prospectively with assessment of their MELD-Na score and symptom burden, according to the Edmonton Symptom Assessment System scale.

Read the detailed description
  1. Methodology - Prospective observational study
  2. Population - All patients with chronic liver disease followed in the Matosinhos Local Health Unit after their first episode of decompensation or are diagnosed with hepatocellular carcinoma in stage C or D of the Barcelona Liver Clinic Cancer will be invited to participate in the study.

    All patients who do not sign consent to participate, patients under 18 years of age and patients who present a recurrent degree of encephalopathy, according to the West-Haven scale, equal or greater than 2, will be excluded.

  3. Sample - Non-probabilistic for convenience
  4. Data collection instrument - Patients will be followed prospectively with quarterly assessment, or after each episode of decompensation, of their MELD-Na score and symptom burden, according to the Edmonton Symptom Assessment System scale (ESAS), with introduction of 3 other symptoms prevalent in patients with chronic liver disease: sexual dysfunction sexual, cramps and pruritus. The minimum analysis for each patient will be 2 assessments.

    All symptoms greater than 5 points will be considered moderate to severe and formal referral to the palliative care team will be discussed with the patient and their attending physician. Subsequently evaluating its effectiveness in symptomatic control.

  5. Aims - This observational study will try to understand if there is a correlation between the evolution of MELD-Na and symptomatic burden of patients with advanced chronic liver disease. As well as the influence that the implementation of palliative care have on symptom burden of advanced chronic liver disease patients.
02

Conditions studied

  • Palliative Care
  • End Stage Liver DIsease

Keywords

  • Hepatology
  • End Stage Liver Disease
  • Palliative Care
03

In context

Liver Diseases

2,081 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.

This study's enrollment of 44 is below the median of 167 across 681 observational studies indexed under Liver Diseases.

Browse Liver Diseases studies →

Lead sponsor

Unidade Local de Saúde de Matosinhos, EPE is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All patients with chronic liver disease followed in the Matosinhos Local Health Unit after their first episode of decompensation or are diagnosed with hepatocellular carcinoma in stage C or D of the Barcelona Liver Clinic Cancer will be invited to participate in the study.

Inclusion criteria

  • All patients with chronic liver disease

Exclusion criteria

Exclusion Criteria:

  • do not sign consent to participate
  • patients under 18 years of age
  • patients who present a recurrent degree of encephalopathy, according to the West-Haven scale, equal or greater than 2
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
44 participants (actual)
Target follow-up
1 Year
Patient registry
Yes

Interventions

  • OtherESAS

    Observation of symptoms

06

What researchers measure

Primary outcomes

  1. MELD ESAS

    Evaluate and correlate the evolution of MELD-Na and ESAS on advanced chronic liver disease.

    Time frame: 1 year

07

Study locations

1 site
  • Hugo Miguel Oliveira
    Matosinhos, Portugal
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06181474
Lead sponsor
Unidade Local de Saúde de Matosinhos, EPE
Responsible party
Hugo Miguel Oliveira (Principal Investigator, Universidade do Porto) — Principal investigator
First posted
Dec 26, 2023
Start date
Jan 1, 2024
Primary completion
Dec 31, 2024
Completion
Jan 25, 2025
Last update
May 4, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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