NCT03044639

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2010

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

January 22, 2017

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 7, 2017

Completed
Last Updated

February 7, 2017

Status Verified

January 1, 2017

Enrollment Period

6.6 years

First QC Date

January 22, 2017

Last Update Submit

February 2, 2017

Conditions

Liver Failure

Outcome Measures

Primary Outcomes (1)

  • Liver function

    Measurement of bilirubin - at the beginning and every three months up to 12 months

    12 months

Secondary Outcomes (4)

  • Liver function 2

    12 months

  • Liver function 3

    12 months

  • Liver function 4

    12 months

  • Liver function 5

    12 months

Study Arms (4)

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.

Drug: Lipid Emulsions, Intravenous

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.

Drug: Lipid Emulsions, Intravenous

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.

Drug: Lipid Emulsions, Intravenous

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.

Drug: Lipid Emulsions, Intravenous

Interventions

Lipid Emulsions, IntravenousDRUG

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.

Also known as: parenteral lipid provision
Provision of LCT emulsions in PNProvision of MCT/LCT emulsions in PNProvision of Olive oil emulsions in PNProvision of SMOF lipid emulsions in PN

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • chronic intestinal failure (CIF) receiving HPN including lipids
  • 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)
  • g lipids/kg body weight per day as a part of PN

You may not qualify if:

  • Existing liver failure: an elevation of SGOT, SGTP, total bilirubin, GGTP, alkaline phosphatase of more than 1.5 times x normal value
  • Patients in whom PN was interrupted for longer than 4 continuous weeks in the preceding 6 months
  • Patients with history of cancer and anti-cancer treatment within the last 5 years
  • Severe hyperlipidemia
  • Severe coagulopathy
  • Severe renal insufficiency
  • Acute thromboembolic events
  • Positive test for HIV, Hepatitis B or C (from medical history)
  • Known or suspected drug or alcohol abuse
  • Participation in another interventional clinical trial in parallel or within three months prior to the start of this clinical trial
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanley Dudrick's Memorial Hospital

Skawina, 32-050, Poland

Location

Related Publications (3)

  • 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.

    PMID: 19426581BACKGROUND

  • 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.

    PMID: 20072779BACKGROUND

  • 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.

    PMID: 29960156DERIVED

MeSH Terms

Conditions

Liver Failure

Interventions

Fat Emulsions, Intravenous

Condition Hierarchy (Ancestors)

Hepatic InsufficiencyLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

EmulsionsColloidsDosage FormsPharmaceutical PreparationsParenteral Nutrition SolutionsPharmaceutical SolutionsSolutionsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesSpecialty Uses of Chemicals

Study Officials

  • Stanislaw Klek, MD PhD

    Stanley Dudrick's Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
No information on the lipid emulsion's type provided neither to the patient nor the leading physician
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized, double-blind, multi-centric study performed in four parallel groups
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the Department

Study Record Dates

First Submitted

January 22, 2017

First Posted

February 7, 2017

Study Start

April 1, 2010

Primary Completion

October 31, 2016

Study Completion

December 31, 2016

Last Updated

February 7, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)