Supplements SMOF in TPN for Liver Transplantation Recipients

NCT04572373 | Completed DMC

• 1 other identifier: 201601322A3
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Transplantation; Total Parenteral Nutrition; End-stage Liver Disease

Keywords

Liver transplantation; SMOFlipid; fish oil

Outcome Measures

Primary Outcomes (2)

• Patient demographics and clinical characteristics of SMOFlipid and non-SMOFlipid groups

  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

  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

Study Arms (2)

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.

Interventions

SMOFlipid DIETARY_SUPPLEMENT

SMOFlipid group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Kaohsiung City, Niaosong District, 833, Taiwan

Location

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MeSH Terms

Conditions

Hyperphagia; End Stage Liver Disease

Interventions

SMOFlipid

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Study Officials

• Chih-Che Lin, MD

  Department of Surgery, Kaohsiung Chang Gung Memorial Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2020
• First Posted: October 1, 2020
• Study Start: January 1, 2012
• Primary Completion: June 30, 2015
• Study Completion: June 30, 2015
• Last Updated: October 8, 2020

Record last verified: 2020-09

Locations

TW (1)