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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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Provision of LCT emulsions in PN | Experimental | 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. |
|
| Provision of MCT/LCT emulsions in PN | Experimental | 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. |
|
| Provision of Olive oil emulsions in PN | Experimental | 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. |
|
| Provision of SMOF lipid emulsions in PN | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lipid Emulsions, Intravenous | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Liver function | Measurement of bilirubin - at the beginning and every three months up to 12 months | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Liver function 2 | Measurement of SGTP - at the beginning and every three months up to 12 months | 12 months |
| Liver function 3 | Measurement of SGOT - at the beginning and every three months up to 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stanislaw Klek, MD PhD | Stanley Dudrick's Memorial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanley Dudrick's Memorial Hospital | Skawina | 32-050 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19426581 | Background | 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. Epub 2009 May 11. | |
| 20072779 | Background | 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. Epub 2010 Jan 14. |
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| ID | Term |
|---|---|
| D017093 | Liver Failure |
| ID | Term |
|---|---|
| D048550 | Hepatic Insufficiency |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D005217 | Fat Emulsions, Intravenous |
| ID | Term |
|---|---|
| D004655 | Emulsions |
| D003102 | Colloids |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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Randomized, double-blind, multi-centric study performed in four parallel groups
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No information on the lipid emulsion's type provided neither to the patient nor the leading physician
|
| 12 months |
| Liver function 4 | Measurement of GGTP - at the beginning and every three months up to 12 months | 12 months |
| Liver function 5 | Measurement of alkaline phosphatase - at the beginning and every three months up to 12 months | 12 months |
| 29960156 | Derived | Klek S, Szczepanek K, Scislo L, Walewska E, Pietka M, Pisarska M, Pedziwiatr M. Intravenous lipid emulsions and liver function in adult chronic intestinal failure patients: results from a randomized clinical trial. Nutrition. 2018 Nov;55-56:45-50. doi: 10.1016/j.nut.2018.03.008. Epub 2018 Mar 22. |
| D057947 |
| Parenteral Nutrition Solutions |
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |