Nutritional intervention for treating muscle loss in cirrhotic patients with fluid retention

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the impact of a 12-week nutritional intervention on patients with liver cirrhosis and refractory ascites who are candidates for transjugular intrahepatic portosystemic shunt (TIPS) placement. The study focuses on individuals diagnosed with sarcopenia, characterized by reduced muscle mass, and aims to evaluate how nutritional support can improve their survival rates post-TIPS. Participants will receive tailored nutritional treatments, including dietary guidance and monitoring of food intake, to assess the effectiveness of these interventions on their clinical outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* men and women with an age ≥ 18 and ≤ 80 years
* clinical, radiological or histological diagnosis of liver cirrhosis
* diagnosis of RA
* confirmation of sarcopenia defined in CT scan as the sum of the psoas muscle areas measured at the level of the 3rd lumbar vertebra (PMA) ≤16 cm2
* informed consent signed

Exclusion Criteria:

* severe hepatic insufficiency (bilirubin\> 5 mg/dl, MELD score\> 18, Child-Pugh score\> 9)
* Congestive heart failure class ≥2 according to New York Heart Association criteria (NYHA)
* Active coronary heart disease (myocardial infarction within 6 months of the study)
* Severe pulmonary hypertension suspected on echocardiogram (systolic pulmonary arterial pressure \[PAPs\]\> 35 mmHg) and confirmed with right cardiac catheterization (PAPs\> 45mmHg)
* Chronic renal failure (creatinine\> 3 mg/dl)
* Performance status ≥2 according to the Eastern Cooperative Oncology Group scale (ECOG)
* History of grade III-IV hepatic encephalopathy or West Haven grade I-II hepatic encephalopathy episodes within the last 3 months
* Uncontrolled systemic sepsis
* Presence of Hepatocellular carcinoma
* Complete portal vein thrombosis
* Active bleeding from gastroesophageal varices. Patients with adequately treated gastroesophageal varices can be included in the study (banding ligation, sclerotherapy)
* Diagnosis of extra hepatic neoplasia
* Transplant recipients
* Patients unable or unwilling to comply with the protocol requirements
* Pregnant or lactating women
* Patients unable to autonomously express their consent (incapable patients)
* any other laboratory condition or result that in the opinion of the Principal Investigator, preclude the subject's participation in the study

Where it's running

• IRCCS ISMETT - Istituto Mediterraneo per i Trapianti e le Terapie ad Alta Specializzazione
  Palermo, Italy Recruiting
• University Clinic for Visceral Surgery and Medicine, Inselspital
  Bern, Switzerland Recruiting

Study contacts

• Study coordinator: Angelo Luca, Radiologist
• Email: aluca@ismett.edu
• Phone: +39 0912192468

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.