Lipids and Neurological Complications in Liver Transplantation (LNCLT)
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|ClinicalTrials.gov Identifier: NCT02544919|
Recruitment Status : Unknown
Verified July 2016 by Amr Mohamed Yassen, Mansoura University.
Recruitment status was: Recruiting
First Posted : September 9, 2015
Last Update Posted : March 27, 2017
|Condition or disease||Intervention/treatment||Phase|
|Neurological Complications||Drug: SMOF lipid (SMOFLIPID) pre treatment||Phase 4|
All patients included in the study will receive the same immuno-suppression protocol based on tacrolimus and mycophenolate mofetil after the induction immuno-suppression during the intra-operative period.
Patients will have a full history taking and full neurological examination 48 hours prior to the designated operative date as a basal record.
the control group will not receive any lipid infusions at all the treatment group will receive the study emulsion (SMOF lipid 20% - Fresenius Kabi) starting 48 hours before the planned surgery day and will continue to receive it for 5 post-operative days by intravenous infusion.
During the post-operative period. patients will be assessed daily by full neurological examination as will as patient complaints (symptoms) related to neurological status for diagnosis of any neurological conditions (complications) that might arise during the study period.
Data will be analysed compared to the basal value in each group and between both control and intervention groups using the appropriate statistical tests.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Impact of Pretreatment With Omega 3 Enriched Lipid Emulsion on Early Neurological Complications After Living Donor Liver Transplantation. A Randomized Controlled Trial>|
|Actual Study Start Date :||September 2015|
|Estimated Primary Completion Date :||September 2017|
|Estimated Study Completion Date :||December 2017|
No Intervention: Control group
No Intervention group: Patients do not receive any lipid emulsion of any type during the study period
Active Comparator: SMOF Group
Intervention Group: Patients receive 1 gm.kg.day-1 SMOFlipid for 48 hours before the operation and 5 days post-operatively.
Drug: SMOF lipid (SMOFLIPID) pre treatment
Other Name: Experimental group
- post-transplant neurological complications [ Time Frame: 5 post-operative days ]Number of participants who develop neurological complications
- Graft functions [ Time Frame: 5 post-operative days ]the laboratory parameters for graft functions in both groups
- survival [ Time Frame: 30 days ]one month mortality
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02544919
|Contact: Amr M. Yassen, MD||01001497044 ext +email@example.com|
|Contact: waleed R Elsarraf, MDfirstname.lastname@example.org|
|Liver transplantation project - Gastroenterology surgical center - Mansoura university||Recruiting|
|Mansoura, Dakahlia, Egypt, 35511|
|Contact: Amr M Yassen, MD +201001497044 email@example.com|
|Contact: Waleed R Elsarraf, MD +201222322727 firstname.lastname@example.org|
|Principal Investigator: Amr M Yassen, MD|
|Sub-Investigator: Mohamed Elmorshidy, MD|
|Sub-Investigator: Elrefaiee Kandil, MD|
|Sub-Investigator: Usama Elsaied, MD|
|Sub-Investigator: Waleed R Elsarraf, MD|
|Principal Investigator:||Amr M Yassen, MD||MAnsoura Faculty of Medicine|