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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06181474
Other study ID # ULSM_131/CES/JAS
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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