Supplements SMOF in TPN for Liver Transplantation Recipients

October 7, 2020 updated by: Chang Gung Memorial Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

54

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • Niaosong District
      • Kaohsiung, Niaosong District, Taiwan, 833
        • Chang Gung Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
SMOFlipid group

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.
Dietary supplement: SMOFlipid
non SMOFlipid group
On the basis of our experience in patient management at this institute, we allocated patients with a pretransplant platelet count less than 40,000/μL and those with a count more than 40,000/μL to the non-SMOFlipid group and the SMOFlipid group , respectively. Patients with well-tolerated oral intake and those in whom the TPN supplement was discontinued within 10 days were excluded from this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient demographics and clinical characteristics of SMOFlipid and non-SMOFlipid groups
Time Frame: 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.
30 days
Coagulopathy profile and nutrition profile in SMOF group and non-SMOFlipid groups
Time Frame: 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))
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Investigators

  • Study Director: Chih-Che Lin, MD, Department of Surgery, Kaohsiung Chang Gung Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2012

Primary Completion (Actual)

June 30, 2015

Study Completion (Actual)

June 30, 2015

Study Registration Dates

First Submitted

September 14, 2020

First Submitted That Met QC Criteria

September 26, 2020

First Posted (Actual)

October 1, 2020

Study Record Updates

Last Update Posted (Actual)

October 8, 2020

Last Update Submitted That Met QC Criteria

October 7, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201601322A3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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