| CTRI Number |
CTRI/2019/01/016915 [Registered on: 04/01/2019] Trial Registered Prospectively |
| Last Modified On: |
03/03/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the effect of Omega-3 fatty acids on outcome of liver transplant patient |
|
Scientific Title of Study
|
Randomized controlled trial to study the effect of intravenous supplementation of Omega-3 fatty acids on outcome of recipients in
Living Donor Liver Transplantation (LDLT) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vivek Rajendran |
| Designation |
Senior Resident |
| Affiliation |
Institute of Liver & Biliary Sciences |
| Address |
Senior Resident,
Department of HPB surgery and liver transplantation,
ILBS, D1 Vasant Kunj,
New Delhi
New Delhi
DELHI
110070
India |
| Phone |
8800984217 |
| Fax |
|
| Email |
vvkhere@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Viniyendra Pamecha |
| Designation |
Professor and Head |
| Affiliation |
ILBS, New Delhi |
| Address |
Department of HPB surgery and liver transplantation,
ILBS, D1 Vasant Kunj,
New Delhi
South
DELHI
110070
India |
| Phone |
|
| Fax |
|
| Email |
viniyendra@yahoo.co.uk |
|
Details of Contact Person
Public Query
|
| Name |
Dr Viniyendra Pamecha |
| Designation |
Professor and Head |
| Affiliation |
ILBS, New Delhi |
| Address |
Department of HPB surgery and liver transplantation,
ILBS, D1 Vasant Kunj,
New Delhi
West
DELHI
110070
India |
| Phone |
|
| Fax |
|
| Email |
viniyendra@yahoo.co.uk |
|
|
Source of Monetary or Material Support
|
| Institute of liver and biliary sciences. D-1 vasant kunj, New Delhi, India. Pin - 110070 |
|
|
Primary Sponsor
|
| Name |
Institute of liver and biliary sciences |
| Address |
ILBS,
D1 Vasant Kunj,
New Delhi - 110070. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Dr Vivek R |
ILBS Hospital |
Department of HPB Surgery,
D1, Vasant Kunj
New Delhi
South
DELHI |
8800984217
vvkhere@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,ILBS |
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 |
| Comparator Agent |
No treatment |
No treatment |
| Intervention |
Omega 3 fatty acid |
10% Omega-3 fatty acid oil will be supplemented in intravenous form from preoperative day1, intraoperatively (anytime during surgery before reperfusion of graft) and from post operative day 1 to day 5 in the study group.
The prepration used will be 100ml injection which contains 10gm of Omega 3 fatty acids.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
All elective liver transplant recipients
Adult patients
Those who consent
|
|
| ExclusionCriteria |
| Details |
Liver transplantation for fulminant hepatic failure
Re-transplantation
Known allergy to the study emulsion
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the effect of omega-3 fatty acids supplementation on recipients in LDLT and correlation with early allograft dysfunction |
Post operative day 7 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the effect of Omega-3 fatty acids supplementation on liver regeneration by CT volumetry |
Post operative day 7 |
| To study the correlation between supplementation of omega-3 fatty acids and trend in post-operative LFTs |
Till discharge |
| Post-operative complications |
Till discharge |
| Duration of hospital stay |
Till discharge |
| Duration of ICU stay |
Till discharge |
|
|
Target Sample Size
|
Total Sample Size="124"
Sample Size from India="124"
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)
|
04/01/2019 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
In this study, we aim to analyse the effect of Omega 3 fatty acid supplementation on recipients undergoing LDLT. In Group A, we are going to supplement Omega 3 fatty acid on preoperative day 1, intraoperatively and up to day 5 post operatively. We will analyse the effect of omega 3 fatty acid supplementation on early allograft dysfunction, its correlation with occurrence of postoperative complications. Group B, will be will constitute the controls for the study and hence attempt to find out the effect of omega 3 fatty acid supplementation on outcome of recipients of LDLT. We will analyse the data and elucidate the value of omega 3 fatty acid supplementation in reducing the occurrence of early allograft dysfunction , complications and effect on liver regeneration in recipients of LDLT. |