Exploring how nutrition affects liver cirrhosis prognosis

The Influence of Nutritional Factors on the Prognosis of Liver Cirrhosis Patients and the Exploration of Predictive Models

This study looks at how nutrition affects the health and survival of people with liver cirrhosis to see if better eating can improve their outcomes.

Quick facts

• Study type: Observational
• Enrollment: 300 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: The Second Affiliated Hospital of Chongqing Medical University (other)
• Locations: 1 site (Chongqing, Chongqing Municipality)
• Trial ID: NCT06328517 on ClinicalTrials.gov

What this trial studies

This observational study investigates the impact of nutritional factors on the prognosis of patients with liver cirrhosis. It collects data on various health metrics, including resting energy expenditure, albumin levels, and muscle function, to assess their relationship with long-term outcomes. Participants are followed up regularly, and survival curves and predictive models are developed based on the collected data. The study aims to enhance existing prognostic tools by incorporating nutritional and functional status into the evaluation of cirrhosis patients.

Who should consider this trial

Good fit: Ideal candidates for this study are patients diagnosed with cirrhosis who are expected to survive for more than three months.

Not a fit: Patients with primary liver cancer or severe comorbidities that may interfere with treatment or assessment will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved prognostic models for liver cirrhosis patients, allowing for better management and treatment strategies.

How similar studies have performed: While there have been studies focusing on nutritional factors in liver disease, this specific approach of integrating nutritional assessment into prognostic models is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Willing and able to sign an informed consent form;
2. Abdominal ultrasound, CT, or MRI showed cirrhosis during the screening period; Fibroscan results during the screening period were\> 17.5kPa;
3. Estimated survival time of more than 3 months;
4. Full capacity for civil conduct.

Exclusion Criteria:

1. The diagnosis of primary liver cancer or was supported by the following evidence: increased alpha-fetoprotein (AFP) (≥100 μg/L) for more than 3 months or liver imaging showed clear liver cancer nodules in the liver;
2. A history of malignancy within 5 years prior to screening, except for specific cancers (such as basal cell skin cancer); current or prior history of major disease that may interfere with personal treatment, assessment or compliance. Major diseases are 25 major diseases as stipulated by the China Insurance Regulatory Commission;
3. Severe lung disease, severe heart disease, diabetes mellitus, or genetic and metabolic diseases;
4. Psychiatric hospitalization, attempted suicide, and / or temporary disability due to mental illness in the past five years;
5. Pregnant or lactating women;
6. The investigator considered not unsuitable for participants.

Where this trial is running

Chongqing, Chongqing Municipality

• The Second Affiliated Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China (RECRUITING)

Study contacts

• Study coordinator: juan Kang, M.D.

Conditions: Cirrhosis, rest energy expenditure, malnutrition, prognosis