Parenteral Lipid Emulsions and the Liver Function

Stanley Dudrick's Memorial Hospital

Status and phase: Completed; Phase 4

Conditions: Liver Failure

Treatments: Drug: Lipid Emulsions, Intravenous

Study type: Interventional

Funder types: Other

Identifiers

NCT03044639

IVLE

Details and patient eligibility

About

The randomized, double-blind, multi-centric study performed in four parallel groups to compare all lipid emulsions, which can be used as a part of PN. Patients with home parenteral nutrition due to stable intestinal failure, were randomly assigned to receive parenteral nutrition with one the following lipid emulsions:

• Long-chained triglycerides (LCT group)
• Medium/ long-chained triglycerides MCT/LCT (50:50, MCT/LCT group))
• Olive oil/ LCT (80:20, OO group))
• SMOFlipid (Omega-3/ olive oil/ MCT/ LCT, SMOF group)

Full description

Intravenous lipid emulsion (IVLE) is the essential component of parenteral nutrition (PN), because it is a very efficient source of energy and essential fatty acids (FA).The prevalence of abnormal liver function tests during PN varies from 15 to 85%, according to most authors.[19-21] The severity of IFALD depends also on underlying disease, especially ongoing sepsis and pre-existing liver disease. A study comparing all lipid emulsions, which can be used as a part of PN, has never been done. The aim of the study was to compare the clinical value of the four most popular intravenous lipid emulsions in regards to the liver function in long term intestinal failure patients.Patients with home parenteral nutrition due to stable intestinal failure, were randomly assigned to receive parenteral nutrition with one the following lipid emulsions:

• Long-chained triglycerides (LCT group)
• Medium/ long-chained triglycerides MCT/LCT (50:50, MCT/LCT group))
• Olive oil/ LCT (80:20, OO group))
• SMOFlipid (Omega-3/ olive oil/ MCT/ LCT, SMOF group) Randomization was performed after assessment and check for in-/exclusion criteria if the patient has met all study eligibility requirements.

The test emulsion became a part of regular PN admixture, which was used to feed patient at home. The study was performed for 12 months.

Enrollment: 64 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. chronic intestinal failure (CIF) receiving HPN including lipids
2. metabolic stability on HPN for more than three months (metabolic stability = the absence of pathological laboratory resulting in the change of PN regime for at least one month)
3. 1.0 g lipids/kg body weight per day as a part of PN

Exclusion criteria

1. Existing liver failure: an elevation of SGOT, SGTP, total bilirubin, GGTP, alkaline phosphatase of more than 1.5 times x normal value
2. Patients in whom PN was interrupted for longer than 4 continuous weeks in the preceding 6 months
3. Patients with history of cancer and anti-cancer treatment within the last 5 years
4. Severe hyperlipidemia
5. Severe coagulopathy
6. Severe renal insufficiency
7. Acute thromboembolic events
8. Positive test for HIV, Hepatitis B or C (from medical history)
9. Known or suspected drug or alcohol abuse
10. Participation in another interventional clinical trial in parallel or within three months prior to the start of this clinical trial
11. For women with childbearing potential (i.e. females who are not chemically or surgically sterile or females who are not postmenopausal) or women of childbearing potential tested positive on standard pregnancy test (urine dipstick) or/ and lactation

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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64 participants in 4 patient groups

Provision of LCT emulsions in PN

Experimental group

Description:

Intervention: Lipid Emulsions, Intravenous. Daily provision of LCT-based lipid emulsion as a part of parenteral nutrition along with dextrose, amino acids, electrolytes, trace elements, vitamins and water in the dose of 0.8-1.0 g/kg/day.

Treatment:

Drug: Lipid Emulsions, Intravenous

Provision of MCT/LCT emulsions in PN

Experimental group

Description:

Intervention: Lipid Emulsions, Intravenous. Daily provision of MCT/LCT lipid emulsion as a part of parenteral nutrition along with dextrose, amino acids, electrolytes, trace elements, vitamins and water in the dose of 0.8-1.0 g/kg/day.

Treatment:

Drug: Lipid Emulsions, Intravenous

Provision of Olive oil emulsions in PN

Experimental group

Description:

Intervention: Lipid Emulsions, Intravenous. Daily provision of Olive-oil/ LCT lipid emulsion as a part of parenteral nutrition along with dextrose, amino acids, electrolytes, trace elements, vitamins and water in the dose of 0.8-1.0 g/kg/day.

Treatment:

Drug: Lipid Emulsions, Intravenous

Provision of SMOF lipid emulsions in PN

Experimental group

Description:

Intervention: Lipid Emulsions, Intravenous. Daily provision of SMOF lipid emulsion as a part of parenteral nutrition along with dextrose, amino acids, electrolytes, trace elements, vitamins and water in the dose of 0.8-1.0 g/kg/day.

Treatment:

Drug: Lipid Emulsions, Intravenous