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The study Aims to investigate the possible beneficial impact of peri-operative or post-operative administration of Omega 3 enriched lipid emulsions on recipients for living donor liver transplantation.
Patients will be divided intro three groups, A control group will receive equivalent volume of glucose 10% solution both 3 days before and 5 days after the operation .
A peri-operative groups, in which patients will receive omega 3 enriched lipid emulsion (SMOFLipid) for 2 days pre-transplantation and 5 days post-transplantation A Post-operative group, in which patients will receive glucose 10% 3 days before the operation and omega 3 enriched lipid emulsion (SMOFLipid) for 5 days post-transplantation The primary outcome objective will be the incidence of Ischemia re-perfusion injury, secondary outcomes includes post-operative complications, graft and patient's outcomes and graft regeneration
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Placebo Comparator | 38 patients Will receive standard oral diet 3 days before the operation will receive similar volume of 10% glucose solution Will receive same solution for 5 days postoperatively |
|
| OMEGA_PRE | Active Comparator | 38 patients Will receive standard oral diet 3 days before the operation will receive lipid supplementation 2 days before the operation with omega 3 enriched lipid emulsion (SMOFlipid) Will receive omega 3 enriched lipid emulsion (SMOFlipid) supplementation for 5 days postoperatively |
|
| OMEGA_POST | Active Comparator | 38 patients Will receive standard oral diet 3 days before the operation will receive glucose 10% solution 2 days before the operation Will receive omega 3 enriched lipid emulsion (SMOFlipid 20%) supplementation for 5 days postoperatively |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SMOFLipid | Dietary Supplement |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Ischemia reperfusion injury | 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Liver functions | 5 days | |
| Early graft regeneration | assessment of percent of liver regeneration 1 month PO | one month |
| Measure | Description | Time Frame |
|---|---|---|
| mortality | 28 days | |
| Renal functions | 28 days | |
| Infection |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amr M Yassen, Md | Contact | +201001497044 | amryassen@hotmail.com | |
| Waleed R Elsarraf, MD | Contact | +201222322727 | welsarraf@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Amr M Yassen, MD | Mansoura University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liver transplantation program - Gastroenterology surgical center - Mansoura university | Recruiting | Al Mansurah | Dakahlia Governorate | 35511 | Egypt |
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| ID | Term |
|---|---|
| D015427 | Reperfusion Injury |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| C000709826 | SMOFlipid |
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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| equivalent volume of 10% glucose solution |
| Dietary Supplement |
Patients will receive same dose of 10% glucose solution for 2 days pre operatives and 5 days post-operative |
|
|
| Late graft regeneration |
assessment of percent of liver regeneration 13 months PO |
| 3 month |
| 28 days |
| length of hospital stay | 30 days |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008722 | Methods |