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CTRI Number  CTRI/2021/06/033941 [Registered on: 01/06/2021] Trial Registered Prospectively
Last Modified On: 01/06/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of early oral feeding after endoscopic intervention in acute variceal bleeding in patients with chronic liver disease: An open-label randomized controlled trial 
Scientific Title of Study   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 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Namrata Singh 
Designation  Dietitian 
Affiliation  AIIMS,New Delhi 
Address  Room no 3100 Teaching block AIIMS New Delhi
Room no 3100 Teaching block AIIMS New Delhi
South
DELHI
110029
India 
Phone  9871137237  
Fax    
Email  namratasinghmohil@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Namrata Singh 
Designation  Dietitian 
Affiliation  AIIMS,New Delhi 
Address  Room no 3100 Teaching block AIIMS New Delhi
Room no 3100 Teaching block AIIMS New Delhi

DELHI
110029
India 
Phone  9871137237  
Fax    
Email  namratasinghmohil@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Namrata Singh 
Designation  Dietitian 
Affiliation  AIIMS,New Delhi 
Address  Room no 3100 Teaching block AIIMS New Delhi
Room no 3100 Teaching block AIIMS New Delhi

DELHI
110029
India 
Phone  9871137237  
Fax    
Email  namratasinghmohil@yahoo.com  
 
Source of Monetary or Material Support  
Room 3068,Teaching Block, AIIMS,New Delhi 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Namrata Singh  All India Institute Of Medical Sciences  room no 3100 Teaching block AIIMS New Delhi
South
DELHI 
011-26594425

namratasinghmohil@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute ethics committee,AIIMS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K746||Other and unspecified cirrhosis ofliver,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  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 continuously for over 16 hours per day with 8 hours of rest at night. 3.Route of administration:At the time of endotherapy, nasogastric tube will be placed 4.Duration and Timing of initiation of intervention: 1 hour after endotherapy. To be continued till 48 hours from endotherapy.  
Comparator Agent  Systemic fasting for 48 hours after endotherapy as per recommendations of EASL.  1.Dose : Dextrose normal saline 75mL 2.Frequency: Per hour 3.Route of administration: Intra Venous 4.Duration :48 hours  
 
Inclusion Criteria  
Age From  14.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. cirrhosis decompensated with ascites who presents with acute variceal bleeding and had undergone endotherapy for esophageal/ gastric varices 
 
ExclusionCriteria 
Details  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
 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
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  
Outcome  TimePoints 
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
 
1) 48 hours
2) 6 weeks 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/06/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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.


 
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