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

Palliative Care Clinical Trial

— MELDESAS  

Official title:

Assessment of the Symptomatic Burden of Patients With Advanced Chronic Liver Disease. Correlation Between the Model for End-Stage Liver Disease (MELD)-Na and the Edmonton Symptom Assessment System Scale (ESAS).

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06181474
• Other study ID #: ULSM_131/CES/JAS
• Status: Recruiting
• Start date: January 1, 2024
• Est. completion date: January 2025

Study information

• Verified date: March 2024
• Source: Unidade Local de Saúde de Matosinhos, EPE
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 2025
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients with chronic liver disease

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

Related Conditions & MeSH terms

• End Stage Liver DIsease
• Liver Diseases
• Palliative Care

Intervention

Other:
• ESAS
Observation of symptoms

Locations

Country	Name	City	State
Portugal	Hugo Miguel Oliveira	Matosinhos

Sponsors (1)

Lead Sponsor	Collaborator
Unidade Local de Saúde de Matosinhos, EPE

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MELD ESAS	Evaluate and correlate the evolution of MELD-Na and ESAS on advanced chronic liver disease.	1 year