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To study the impact of pretreatment of living donor liver transplantation recipients with SMOF lipid on the incidence and severity of post-transplantation neurological complications in patients receiving tacrolimus based immunosuppression protocol
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | No Intervention | No Intervention group: Patients do not receive any lipid emulsion of any type during the study period | |
| SMOF Group | Active Comparator | Intervention Group: Patients receive 1 gm.kg.day-1 SMOFlipid for 48 hours before the operation and 5 days post-operatively. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SMOF lipid (SMOFLIPID) pre treatment | Drug | Experimental Arm |
|
| Measure | Description | Time Frame |
|---|---|---|
| post-transplant neurological complications | Number of participants who develop neurological complications | 5 post-operative days |
| Measure | Description | Time Frame |
|---|---|---|
| Graft functions | the laboratory parameters for graft functions in both groups | 5 post-operative days |
| survival | one month mortality | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amr M. Yassen, MD | Contact | 01001497044 | +2 | amryassen@hotmail.com |
| waleed R Elsarraf, MD | Contact | welsarraf@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Amr M Yassen, MD | MAnsoura Faculty of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liver transplantation project - Gastroenterology surgical center - Mansoura university | Recruiting | Al Mansurah | Dakahlia Governorate | 35511 | Egypt |
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| ID | Term |
|---|---|
| D020258 | Neurotoxicity Syndromes |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D011041 | Poisoning |
| D064419 | Chemically-Induced Disorders |
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| ID | Term |
|---|---|
| C000709826 | SMOFlipid |
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