Supplements SMOF in TPN for Liver Transplantation Recipients

Completed

• Conditions: End-stage Liver Disease; Liver Transplantation; Total Parenteral Nutrition
• Interventions: Dietary Supplement: SMOFlipid

• Registration Number: NCT04572373
• Lead Sponsor: Chang Gung Memorial Hospital

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 Timeline

• Study Start: 2012-01-01
• Primary Completion: 2015-06-30
• Study Completion: 2015-06-30
• Status Verified: 2020-09
• Study First Submitted: 2020-09-14
• Study First Submitted QC: 2020-09-26
• Study First Posted: 2020-10-01
• Last Update Submitted: 2020-10-07
• Last Update Posted: 2020-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SMOFlipid group	SMOFlipid	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. Furthermore, SMOFlipid was discontinued when the platelet count decreased to 40,000/μL or less. In all cases, heparinisation was prescribed to maintain the aPTT level between 1.5 and 2 times the normal controlled level at least for 10-14 days, with daily blood examination conducted. Oral administration of dipyridamole (75 mg, QID) for 3 months was indicated for stimulation of antiplatelet activity when the platelet count increased to 40,000/μL or more.

Primary Outcome Measures

Name	Time	Method
Patient demographics and clinical characteristics of SMOFlipid and non-SMOFlipid groups	30 days	Medical records including patient demographics, preoperative history, physical examination, clinical course, laboratory studies, aetiology of liver disease, severity of liver disease including Child-Pugh score and the Model for End-Stage Liver Disease (MELD) score, postoperative complications, and length of ICU and hospital stay were collected and reviewed.
Coagulopathy profile and nutrition profile in SMOF group and non-SMOFlipid groups	30 days	Medical records including laboratory studies (PT (sec), INR (sec), aPTT (sec), Platelet (103/uL), Albumin (g/dL), Cholesterol (mg/dL), Triglyceride (mg/dL))

Trial Locations

Locations (1)

Chang Gung Memorial Hospital; 🇨🇳 Kaohsiung, Niaosong District, Taiwan