Parenteral Lipid Emulsions and the Liver Function

Liver Failure Clinical Trial

Official title:

Four Parenteral Lipid Emulsions and the Liver Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03044639
• Other study ID #: IVLE
• Status: Completed
• Phase: Phase 4
• First received: January 22, 2017
• Last updated: February 2, 2017
• Start date: April 1, 2010
• Est. completion date: December 31, 2016

Study information

• Verified date: January 2017
• Source: Stanley Dudrick's Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: December 31, 2016
• Est. primary completion date: October 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Liver Failure

Intervention

Drug:
• Lipid Emulsions, Intravenous
The every day provision of 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.

Locations

Country	Name	City	State
Poland	Stanley Dudrick's Memorial Hospital	Skawina

Sponsors (1)

Lead Sponsor	Collaborator
Stanley Dudrick's Memorial Hospital

Country where clinical trial is conducted

Poland, 

References & Publications (2)

Calder PC, Jensen GL, Koletzko BV, Singer P, Wanten GJ. Lipid emulsions in parenteral nutrition of intensive care patients: current thinking and future directions. Intensive Care Med. 2010 May;36(5):735-49. doi: 10.1007/s00134-009-1744-5. Review. — View Citation

Calder PC. Hot topics in parenteral nutrition. Rationale for using new lipid emulsions in parenteral nutrition and a review of the trials performed in adults. Proc Nutr Soc. 2009 Aug;68(3):252-60. doi: 10.1017/S0029665109001268. Review. Erratum in: Proc Nutr Soc. 2011 May;70(2):281. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Liver function	Measurement of bilirubin - at the beginning and every three months up to 12 months	12 months
Secondary	Liver function 2	Measurement of SGTP - at the beginning and every three months up to 12 months	12 months
Secondary	Liver function 3	Measurement of SGOT - at the beginning and every three months up to 12 months	12 months
Secondary	Liver function 4	Measurement of GGTP - at the beginning and every three months up to 12 months	12 months
Secondary	Liver function 5	Measurement of alkaline phosphatase - at the beginning and every three months up to 12 months	12 months