Clinical trial NCT04572373: Supplements SMOF in TPN for Liver Transplantation Recipients
Official title: Supplements SMOF in TPN for Liver Transplantation Recipients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Transplantation
Total Parenteral Nutrition
End-stage Liver Disease
Keywords: Liver transplantation
SMOFlipid
fish oil
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2020-10-01
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients who underwent LT at KCGMH between Jan 2012 and June 2015 were screened in this study. The medical records of patients were retrospectively reviewed to check if TPN was provided in the last 14 days in the peri-transplantation period. TPN and SMOFlipid support were indicated for patients who received NPO for more than 3 days, such as those with repeated laparotomy, staged biliary reconstruction, massive nasogastric (NG) drainage (\>500 mL/day), ileus, diarrhoea, poor digestion (NG extraction \>50 mL/time), and chylous ascites.

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.

Eligibility criteria: Inclusion Criteria:

Adult (age \> 18 years) LT recipients were enrolled

Exclusion Criteria:

1. Renal dysfunction (eGFR \< 60 mL/min/1.73 m2)
2. Patients with well-tolerated oral intake and those in whom the TPN supplement was discontinued within 10 days were excluded from this study.

Primary outcomes:
measure: Patient demographics and clinical characteristics of SMOFlipid and non-SMOFlipid groups
timeFrame: 30 days
measure: Coagulopathy profile and nutrition profile in SMOF group and non-SMOFlipid groups
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Chang Gung Memorial Hospital
state: Niaosong District
Study officials:
affiliation: Department of Surgery, Kaohsiung Chang Gung Memorial Hospital
name: Chih-Che Lin, MD
role: STUDY_DIRECTOR
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