Health Condition 1: K721- Chronic hepatic failure Health Condition 2: K740- Hepatic fibrosis
Conditions
Interventions
Intervention1: Nutrition therapy: Outpatient intensive nutrition therapy plus Standard Medical therapy (3 months)
Intervention2: Nutritional: A recommended daily
diet based on the requirements will be
Sponsors
Post Graduate Institute of Medical Education and Research PGIMER
Eligibility
Inclusion criteria
Inclusion criteria: A. Age more than 18 years and less than 75 years B. Patients with a confirmed diagnosis of Acute-on-chronic liver failure by APASL criteria APASL ACLF defined by serum bilirubin more than and equal to 5 mg/dl & coagulopathy (INR more than equal to 1.5 or PT less than 40%), complicated within 4 weeks by ascites and/or encephalopathy in a patient with chronic liver disease C. Presence of frailty
Exclusion criteria
Exclusion criteria: 1. Patients with AARC score more than 10 2. Patients with MELD score more than 30 3. Obese patient (BMI more than 25kg/m2) 4. Patients with active malignancy, hepatocellular carcinoma and, the end-stage renal disease. 5. Active alcohol abuse at the time of enrollment 6. Patients having prior study enrollment or enrollment in another conflicting study 7. Patients, who are not willing to participate in the study, will be excluded. 8. Patients who are participating in other clinical trials within past 3 months 9. Patients who has an active evidence of infection 10. Patients who had acute organic brain disease in the past 6 months 11. Patients who have severe hemodynamic instability, serious heart disease, severe bradycardia, or tachycardia at rest 12. Patients having renal failure (creatinine clearance rate less than and equal to 60 mL/min/1.73 m2) 13. Patients who are not able to perform the strength exercise; severe cognitive impairment (Mini-Mental State Examination less than and equal to 17), overt hepatic encephalopathy, or patients who had physical disability)
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1. To see the effect of outpatient intensive nutrition therapy on frailty score as measured by the Liver Frailty Index (LFI). 2. To see the changes in prognostic scores (CTP, MELD, MELD-Na, AARC) 3. Hospitalization and need of liver transplant. 4. Improvement in body mass index, mid-arm circumference (MAC), mid-arm muscle circumference (MAMC). Timepoint: Improvement in LFI, body mass index, mid-arm circumference, mid-arm muscle circumference at 3 month follow up | — |
Primary
| Measure | Time frame |
|---|---|
| To assess the impact of outpatient intensive nutrition therapy plus standard medical treatment (SMT) compared to SMT alone on the survival in patients with acute-on-chronic liver failure.Timepoint: Enrolment- 9 months Follow up- Weekly for first month then monthly for 3 months | — |
Countries
India
Contacts
Public ContactDr Sunil Taneja
PGIMER, Chandigarh
Outcome results
None listed