Viewing Study NCT04572373



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Last Modification Date: 2024-10-26 @ 1:46 PM
Study NCT ID: NCT04572373
Status: COMPLETED
Last Update Posted: 2020-10-08
First Post: 2020-09-14

Brief Title: Supplements SMOF in TPN for Liver Transplantation Recipients
Sponsor: Chang Gung Memorial Hospital
Organization: Chang Gung Memorial Hospital

Study Overview

Official Title: Supplements SMOF in TPN for Liver Transplantation Recipients
Status: COMPLETED
Status Verified Date: 2020-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Liver transplantation LT is one of the widely recognised and leading treatments for end-stage liver disease Nutrition impacts its success Total parenteral nutrition TPN is usually prescribed for patients recommended prolonged fasting after LT The supplement of SMOFlipid soybean oil MCT oil olive oil and fish oil is easily metabolised to produce energy and it possesses anti-inflammatory effects however SMOFlipid emulsion use raises concerns regarding coagulopathy after LT This study investigated the postoperative correlation between SMOFlipid and coagulation in LT
Detailed Description: Liver failure is characterised by the loss of liver function and is complicated with hepatic encephalopathy and coagulopathy Liver transplantation LT is one of the widely recognised and leading treatments for end-stage liver disease Malnutrition is one of the common manifestations of this critical condition and is also an independent predictor of mortality Several studies have shown that malnutrition is a poor prognostic factor for LT which indicates that nutritional support may reduce LT complications and improve survival

Total parenteral nutrition TPN is usually prescribed for patients recommended prolonged fasting after LT The supplement of SMOFlipid soybean oil MCT oil olive oil and fish oil has the advantage of being easily metabolised to produce energy and it has anti-inflammatory effects The major therapeutic mechanism of fish oil is the attenuation of systematic inflammation which may decrease the mortality risk in patients with severe injury and sepsis SMOFlipid has been proven to be safe and well tolerated in a wide range of clinical conditions and it is used as the standard lipid emulsion Moreover the short-term application of parenteral fish oil with soybean oil not only significantly reduces the parameters of liver damage in the postoperative period but also leads to a more balanced immune response which may result in the faster resolution of inflammation and recovery However SMOFlipid emulsion use may be associated with coagulopathy after LT Early studies have shown that the dietary intake of n-3 fatty acids which is a component of fat is associated with antithrombotic effects but increases the risk of bleeding A detailed analysis is lacking and these observations have yet to be proven this concern persists Hence the investigators should pay attention to the bleeding tendency when using fish oil fat emulsion because it may aggravate the risk of bleeding Therefore the use of fish oil-containing fat emulsion and its related risks is a clinically important issue in early LT that should be investigated because liver function is not restored immediately after transplantation and there is a tendency of coagulopathy Thus classical haemostasis parameters such as activated partial thromboplastin time aPTT and platelet count are measured prior to surgery and before the start of TPN However many questions remain unanswered regarding nutritional assessment and support for these seriously ill nutritionally and metabolically complex patients This study evaluated the effect of the SMOFlipid supplement in TPN in LT patients

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None