A prognostic model that adds nutritional and metabolic measures for liver cirrhosis

Exploration of a Novel Prognostic Prediction Model for Liver Cirrhosis

This project will test whether adding objective nutritional measurements and metabolic profiles to routine clinical data can better predict outcomes for adults with liver cirrhosis.

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 (Academic / other)
• Locations: 1 site (Chongqing, Chongqing Municipality)
• Trial ID: NCT07031843 on ClinicalTrials.gov

What this trial studies

This is a prospective observational cohort of adults with cirrhosis enrolled at the Second Affiliated Hospital of Chongqing Medical University. Researchers will collect clinical data, standard liver and renal labs, nutritional scores (BMI, PNI, GNRI), resting energy expenditure, and non-targeted blood metabolomics. Patients will be followed at 3 months, 6 months, 1 year, and 2 years to record survival, hepatic events, and complications. Statistical analyses will identify nutrition- and metabolite-based variables to build and optimize a novel prognostic scoring model for cirrhosis.

Who should consider this trial

Good fit: Adults aged 18 to 75 with a clinical diagnosis of liver cirrhosis, expected survival over three months, and capacity to consent and attend follow-up visits are ideal candidates.

Not a fit: Patients with active primary liver cancer, recent other malignancies, severe cardiopulmonary or genetic metabolic diseases, or those unable to complete follow-up are unlikely to benefit from this project.

Why it matters

Potential benefit: If successful, the model could give patients more accurate prognoses and support earlier, targeted nutritional care that may reduce complications and improve outcomes.

How similar studies have performed: Previous studies have shown malnutrition predicts poorer outcomes in cirrhosis and metabolomics is an emerging approach with some promising but not yet widely validated prognostic results.

Eligibility criteria

Inclusion Criteria:

Participants must meet all of the following criteria to be eligible for this study.

1. Willingness and ability to sign the informed consent form.
2. Male or female, aged 18 to 75 years.
3. A diagnosis of liver cirrhosis that meets the reference criteria of the Chinese Society of Hepatology's "Guidelines for the Diagnosis and Treatment of Liver Cirrhosis".
4. An expected survival of over 3 months.
5. Full civil competence.

Exclusion Criteria:

1. Primary liver cancer diagnosis, or supporting evidence of elevated alpha-fetoprotein (AFP≥100μg/L) for \>3 months, or imaging evidence of hepatic cancer nodules.
2. Malignancy history within 5 years before screening, except for specific cured cancers (e.g., basal cell skin cancer); current or past major illnesses (as defined by the China Insurance Regulatory Commission's 25 critical illnesses) that may affect treatment, assessment, or compliance.
3. Severe pulmonary, cardiac, diabetic, or genetic metabolic diseases.
4. Psychiatric hospitalization, suicide attempts, or temporary disability due to mental illness in the past 5 years.
5. Pregnant or breastfeeding women.
6. Individuals deemed unsuitable by the investigator.

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; cirrhosis; disease prognosis model; metabolomics; nutritional assessment