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Trial record 15 of 582 for:    bilirubin AND liver function

Parenteral Lipid Emulsions and the Liver Function

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ClinicalTrials.gov Identifier: NCT03044639
Recruitment Status : Completed
First Posted : February 7, 2017
Last Update Posted : February 7, 2017
Sponsor:
Information provided by (Responsible Party):
Stanislaw Klek, Stanley Dudrick's Memorial Hospital

Brief 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)

Condition or disease Intervention/treatment Phase
Liver Failure Drug: Lipid Emulsions, Intravenous Phase 4

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, double-blind, multi-centric study performed in four parallel groups
Masking: Single (Investigator)
Masking Description: No information on the lipid emulsion's type provided neither to the patient nor the leading physician
Primary Purpose: Prevention
Official Title: Four Parenteral Lipid Emulsions and the Liver Function
Actual Study Start Date : April 1, 2010
Actual Primary Completion Date : October 31, 2016
Actual Study Completion Date : December 31, 2016

Arm Intervention/treatment
Experimental: Provision of LCT emulsions in PN
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.
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.
Other Name: parenteral lipid provision

Experimental: Provision of MCT/LCT emulsions in PN
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.
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.
Other Name: parenteral lipid provision

Experimental: Provision of Olive oil emulsions in PN
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.
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.
Other Name: parenteral lipid provision

Experimental: Provision of SMOF lipid emulsions in PN
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.
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.
Other Name: parenteral lipid provision




Primary Outcome Measures :
  1. Liver function [ Time Frame: 12 months ]
    Measurement of bilirubin - at the beginning and every three months up to 12 months


Secondary Outcome Measures :
  1. Liver function 2 [ Time Frame: 12 months ]
    Measurement of SGTP - at the beginning and every three months up to 12 months

  2. Liver function 3 [ Time Frame: 12 months ]
    Measurement of SGOT - at the beginning and every three months up to 12 months

  3. Liver function 4 [ Time Frame: 12 months ]
    Measurement of GGTP - at the beginning and every three months up to 12 months

  4. Liver function 5 [ Time Frame: 12 months ]
    Measurement of alkaline phosphatase - at the beginning and every three months up to 12 months



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03044639


Locations
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Poland
Stanley Dudrick's Memorial Hospital
Skawina, Poland, 32-050
Sponsors and Collaborators
Stanley Dudrick's Memorial Hospital
Investigators
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Principal Investigator: Stanislaw Klek, MD PhD Stanley Dudrick's Memorial Hospital

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Stanislaw Klek, Head of the Department, Stanley Dudrick's Memorial Hospital
ClinicalTrials.gov Identifier: NCT03044639     History of Changes
Other Study ID Numbers: IVLE
First Posted: February 7, 2017    Key Record Dates
Last Update Posted: February 7, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Liver Failure
Liver Diseases
Hepatic Insufficiency
Digestive System Diseases
Vitamins
Trace Elements
Micronutrients
Fat Emulsions, Intravenous
Nutrients
Growth Substances
Physiological Effects of Drugs
Parenteral Nutrition Solutions
Pharmaceutical Solutions