Health Condition 1: K746- Other and unspecified cirrhosis ofliver
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. cirrhosis decompensated with ascites who presents with acute variceal bleeding and had undergone endotherapy for esophageal/ gastric varices
Exclusion criteria
Exclusion criteria: 1) Cirrhosis without ascites 2) ACLF at presentation 3) Cirrhosis with HCC 4) Pregnancy and lactation 5) Refusal to give consent. 6) Infections like spontaneous bacterial peritonitis, pneumonia, cellulitis at presentation 7) Age less than 14 or more than 65 years 8) Patients with non-cirrhotic portal hypertension 9) Patients undergoing rescue therapy like Ella-Dennis stent placement or rTIPS 10) Acute kidney injury (serum creatinine >1.5mg/dl) at presentation 11) Acute variceal bleeding with shock persisting for more than 1 hour (MAP
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of rebleeding within 5 days of onset of AVB (ie cumulative incidence of failure to control bleed and very early rebleeding) in both arms.Timepoint: within 5 days of onset of AVB in both arms. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Incidence of early rebleeding 2)Incidence of post-bleeding infections during episode of AVB 3) Incidence of post-bleeding infections after an episode of AVB 4) Comparison of endotoxemia between two arms at baseline and after 48 hours of intervention 5) Comparison of systemic inflammatory markers and iFABP at baseline and after 48 hours of intervention 6) 6-week mortality 7) Incidence of post-bleeding decompensations on follow-up 8) Duration of hospitalization Timepoint: 1) 48 hours 2) 6 weeks | — |
Countries
India
Contacts
AIIMS,New Delhi