Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201501000982252 Date of Registration: 24/12/2014
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of omega-3 on hepatic regeneration in adult living donors undergoing hepatic resections for liver transplantation
Official scientific title Effect of omega-3 on hepatic regeneration in adult living donors undergoing hepatic resections for liver transplantation: A randomized controlled trial
Brief summary describing the background and objectives of the trial It has been shown that Fatty acids, as essential nutrients, have a wide range of biological function and omega-3 polyunsaturated fatty acid (¿-3 PUFA) supplementation is also reported to be involved in modifying the organic biochemical environment. Recently, ¿-3 PUFAs were found to play significantly protective roles in the liver, cardiovascular system and kidney and they have been widely used in clinical perioperative total parenteral nutrition. In studies conducted using experimental models, it has been shown that ¿-3 PUFAs has antioxidant properties and stimulate liver regeneration after 90% hepatectomy in rats.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Digestive System,Donor Liver Transplantation
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/10/2013
Actual trial start date 01/01/2014
Anticipated date of last follow up 30/06/2014
Actual Last follow-up date 30/06/2014
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 40
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomisation (block size of 4 and the block size was not variable) Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Smof lipid 5-10ml /kg SMOF LIPID 2DAYS BEFORE SURGERY AND POSTOPERATIVE DAY 0 5-10ml /kg SMOF LIPID was given 2DAYS BEFORE SURGERY AND POSTOPERATIVE DAY 0 20
Control Group Controls no drug in Saline infusion 2DAYS BEFORE SURGERY AND POSTOPERATIVE DAY 0 no drug in Saline infusion for 2DAYS BEFORE SURGERY AND POSTOPERATIVE DAY 0 20 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
normal liver function and kidney function normal serum level of cholesterol and other lipid profile no cardiovascular or respiratory problems knowing allergy to egg increased serum level of cholesterol Unwilling to participate in the study 18 Year(s) 45 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 01/10/2013 Menoufyia University, National Liver Institute (NLI), IRB
Ethics Committee Address
Street address City Postal code Country
Yassin abd elghafar street Shebeen El.koom Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Liver volume 1 month after surgery
Secondary Outcome liver function tests Pre and postoperative for 7 day
Secondary Outcome hepatocyte growth factor Pre and postoperative for 7 day
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
National liver institute Yassin abd elghafar street Shebeen El.koom Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
National liver institute Yassin abd elghafar street Shebeen El.koom Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor National liver institute Yassin abd elghafar street Shebeen El.koom Egypt University
COLLABORATORS
Name Street address City Postal code Country
Eman sayed Yassin abd elghafar street Shebeen El.koom Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator eman sayed emansayed825@gmail.com 002-01282271464 Yassin abd elghafar street
City Postal code Country Position/Affiliation
SHEBIN el kom Egypt Lecturer of Anaesthesia and Intensive Care
Role Name Email Phone Street address
Public Enquiries Elsayedamr Basma elsayedamr@yahoo.com 002-01223106023 30 Garden City Smouha
City Postal code Country Position/Affiliation
Alexandria 21516 Egypt Patient Information Manager
Role Name Email Phone Street address
Scientific Enquiries Eman sayed emansayed825@gmail.com 002-01282271464 Yassin abd elghafar street
City Postal code Country Position/Affiliation
SHEBIN el kom Egypt Lecturer of Anaesthesia and Intensive Care
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information