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
|
|
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
|
|
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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