Health Condition 1: K746- Other and unspecified cirrhosis ofliver
Conditions
Interventions
Intervention1: Routine vaccination plus Standard Medical Therapy: These patients will be provided Pneumococcal and annual Influenza vaccination after the decompensation episode.
They will follow up as
Sponsors
All India Institute of medical Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 1. All patients with cirrhosis presenting with the first decompensation event (ascites, VH and/or HE) with a Child score of 7 or more 2. Willing to participate in the study
Exclusion criteria
Exclusion criteria: 1. Patients belonging to Child Class-A 2. Non-cirrhotic causes of portal hypertension 3. Hepatocellular carcinoma or any other underlying non-hepatic malignancy 4. Absence of ascites 5. History of allergic reactions to prior vaccine or known allergies to any vaccine component 6. Pregnant women 7. Patients who have received any prior vaccination (Hepatitis A, Hepatitis B, pneumococcus, influenza) 8. Denied consent for participation 9. Patients who have undergone transjugular intrahepatic portosystemic shunts, balloon occluded retrograde transvenous occlusion, portosystemic shunt occlusion for HE 10. Chronic Kidney Disease, Chronic Heart failure, Chronic obstructive pulmonary disease 11. Patients with primary or secondary immunodeficiency syndromes 12. Patients on antibiotic prophylaxis for any other coexistent infectious condition
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of rates of further decompensation and mortality at 2 years between the 2 groups.Timepoint: Comparison of rates of further decompensation and mortality at 2 years between the 2 groups. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Comparison of incidence of individual components of further decompensation between the two groups at 1, 3, 6, 12 and 24 months 2. To assess the differences in all-cause mortality at 1, 3, 6, 12 and 24 months between the two arms 3. To assess the rates of recompensation between the two groups at 12 and 24 months. 4. To assess the seroprevalence of Hepatitis A by measuring anti Hep A IgG and Hepatitis B by measuring HbsAg and anti Hbs Ab among the study population. 5. To assess the knowledge and apprehensions to vaccine administration among patients of both groups.Timepoint: 1. 1,3,6,12 and 24 months 2. 1,3,6,12 and 24 months 3. 12 and 24 months 4. 24 months 5. 24 months | — |
Countries
India
Contacts
Public ContactDr Sudipta Nandi
All India Instiute of Medical sciences
Outcome results
None listed