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

Not yet recruiting

Conditions: Other and unspecified cirrhosis ofliver,

Registration Number: CTRI/2021/06/033941

Brief Summary: The present randomized controlled trial was designed to evaluate the impact of early initiation of oral nutrition during acute variceal bleedingon outcomes of early rebleeding in patients with chronic liver disease.

Patients will be randomized in a 1:1 ratio to either oral nutrition arm or systemic fasting arm

Group-A: Early oral nutrition arm:

Route of administration: At the time of endotherapy, nasogastric tube will be placed in the intervention arm.

Timing of initiation and duration of intervention: 1 hour after endotherapy. To be continued till 48 hours from endotherapy.

Composition of feed: Polymeric commercial formula of 1600Kcal per day and 60 g proteins per day with energy density of 1 Kcal/ml will be provided. Feed would be given over 16 hours per day with 8 hours of rest at night.

Protocol violation: Any patient with less than 500Kcal per day of feed will be treated as protocol violation.

Group-B: Systemic fasting for 48 hours after endotherapy as per recommendations of EASL. During the period, patients will be given dextrose normal saline for 48 hours at the rate of 75ml/hour. Sips of oral liquids will be allowed.

Post-intervention follow up- After 48 hours of endotherapy, patients in both arms will be given a standard dietary chart catering to 25kCal/kg and 1g/kg protein according to body weight. Patients will be taking non-selective beta blockers for secondary prophylaxis and will undergo repeat endoscopy at 3-week interval for further eradication of varices. The duration of present study is 6 weeks. Patients will be followed at outpatient clinics at 1st week, 3rd week and 6th week as well as telephonically contacted and prespecified outcomes will be enquired from them.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 80

Inclusion Criteria

cirrhosis decompensated with ascites who presents with acute variceal bleeding and had undergone endotherapy for esophageal/ gastric varices.

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<60 mm Hg) afterendotherapy.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	within 5 days of onset of AVB in both arms.

Secondary Outcome Measures

Name	Time	Method
1)Incidence of early rebleeding	2)Incidence of post-bleeding infections during episode of AVB

Trial Locations

Locations (1): All India Institute Of Medical Sciences
🇮🇳
South, DELHI, India
All India Institute Of Medical Sciences
🇮🇳South, DELHI, India
Namrata Singh
Principal investigator
011-26594425
namratasinghmohil@yahoo.com