Ensayos clínicos

Inclusion Criteria:

• Age > 18 years old.
• Outpatient.
• Able to give informed consent determined by MMSE ≥ 25 (those under this will be excluded and no LAR will be required).
• In the opinion of the PI, able to be compliant with clinic follow-up over time.
• Cirrhosis diagnosed by any one or more of the following:
  • Liver biopsy;
  • History of or current decompensation.
    • Ascites on diuretics, requiring TIPS or large volume paracentesis.
    • Prior overt HE.
    • Variceal bleeding.
    • Liver-lung syndromes (hepato-pulmonary syndrome, portopulmonary hypertension, hepatic hydrothorax).
    • Jaundice (serum bilirubin > 5mg/dl).
    • Hepato-renal syndrome or stage 2 AKI:
      • In a patient with chronic liver disease.
    • Fibroscan > 14.6 kPa.
    • Platelet count < 150,000 and AST/ALT ratio > 1.
• Able and willing to provide samples.

Specific additional inclusion criteria for the three subgroups:

• Patients without prior decompensation.
• No history of overt HE on therapy, variceal bleeding being eradicated/on BB, HRS, ascites on current diuretics.
• Control of underlying disease etiology should be at least 3 months prior.
  • SVR for HCV;
  • HBV suppression.
• Patients with prior /current decompensation without history of prior HE.
  • No history of prior overt HE (defined as grade 2 or higher HE per West-Haven criteria requiring hospitalization, initiation or change of therapy).
  • History of any of the other decompensating events as above.
  • Control of underlying disease etiology should be at least 3 months prior:
    • Alcohol abstinence.
    • SVR for HCV.
    • HBV suppression.
• Patients with prior/current decompensation with history of prior HE.
  • History of prior overt HE (defined as grade 2 or higher HE per West-Haven criteria requiring hospitalization, initiation or change of therapy), OR
  • Currently on therapy for HE, OR
  • Ascites especially refractory ascites.
  • With or without other prior variceal bleeding.
  • Control of underlying disease etiology should be at least 3 months prior:
    • Alcohol abstinence;
    • SVR for HCV;
    • HBV suppression.

Exclusion Criteria: 

• Unclear diagnosis of cirrhosis.
• Unable to provide informed consent, follow-up or provide samples
• On hospice..
• Acute Alcoholic hepatitis.
• Active malignancy other than HCC.
• HCC outside Milan criteria.
• End-stage organ disease in other organs:
  • On dialysis;
  • On home oxygen;
  • Systolic CHF with EF< 40%.
• Inpatient status.
• Prior bariatric surgery.
• Prior bone marrow or solid organ transplant.
• HIV infection.