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Effect of early oral feeding after endoscopic intervention in acute variceal bleeding in patients with chronic liver disease: An open-label randomized controlled trial

Impact of early oral feeding after endotherapy in acute variceal bleeding on outcomes in patients with chronic liver disease: An open-label randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/06/033941
Enrollment
80
Registered
2021-06-01
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K746- Other and unspecified cirrhosis ofliver

Interventions

Intervention1: Early oral feeding: 1.Dose:Polymeric commercial formula of 1600Kcal and 60 g proteins per day with energy density of 1 Kcal/ml will be provided 2. Frequency: Feed would be given cont

Sponsors

NIL
Lead Sponsor

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

MeasureTime 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

MeasureTime 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

Public ContactNamrata Singh

AIIMS,New Delhi

namratasinghmohil@yahoo.com9871137237

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026