Crossover Study on the Effect of Omegaven in Combination With Different Lipid Emulsions in Home Parenteral Nutrition

NCT03149653 | Completed Phase 4

• 1 other identifier: NT13236-4/2012
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to evaluate the safety and tolerance of ClinOleic or Lipoplus or SMOFlipid lipid emulsions. After 6 weeks of each lipid emulsion, Omegaven (fish oil) was added for a further 4 weeks. The safety and tolerance was evaluated after each lipid emulsion cycle by biochemistry, hematology and coagulation variables, vital signs and adverse events. We also analysed fatty acid profiles in plasma or erythrocyte phospholipids, antioxidant enzyme activities, lipid peroxidation products, plasma lipids and pro-inflammatory cytokine production after in vitro stimulation of whole blood by lipopolysacharide in HPN patients. The non-interventional group of healthy controls was included for comparison.

Conditions

Parenteral Nutrition

Keywords

lipid emulsion; olive oil; fish oil; intestinal failure; home parenteral nutrition

Outcome Measures

Primary Outcomes (4)

• Change from baseline lipid emulsion production of TNF-alpha after in vitro stimulation of whole blood by lipopolysacharide at 4 weeks of Omegaven lipid emulsion addition

  The whole blood culture supernatant concentration of TNF-alpha (ng/L)

  day 42, day 70

• Change from baseline lipid emulsion production of IL-1-beta after in vitro stimulation of whole blood by lipopolysacharide at 4 weeks of Omegaven lipid emulsion addition

  The whole blood culture supernatant concentration of IL-1-beta (ng/L)

  day 42, day 70

• Change from baseline lipid emulsion production of IL-6 after in vitro stimulation of whole blood by lipopolysacharide at 4 weeks of Omegaven lipid emulsion addition

  The whole blood culture supernatant concentration of IL-6 (ng/L)

  day 42, day 70

• Change from baseline lipid emulsion production of IL-8 after in vitro stimulation of whole blood by lipopolysacharide at 4 weeks of Omegaven lipid emulsion addition

  The whole blood culture supernatant concentration of IL-8 (ng/L)

  day 42, day 70

Secondary Outcomes (19)

• Change from baseline lipid emulsion plasma concentration of TNF-alpha at 4 weeks of Omegaven lipid emulsion addition

  day 42, day 70

• Change from baseline lipid emulsion plasma concentration of IL-1-beta at 4 weeks of Omegaven lipid emulsion addition

  day 42, day 70

• Change from baseline lipid emulsion plasma concentration of IL-6 at 4 weeks of Omegaven lipid emulsion addition

  day 42, day 70

• Change from baseline lipid emulsion plasma concentration of IL-8 at 4 weeks of Omegaven lipid emulsion addition

  day 42, day 70

• Change from baseline lipid emulsion plasma concentration ratio of oxidized LDL/LDL cholesterol at 4 weeks of Omegaven lipid emulsion addition

  day 42, day 70

Study Arms (3)

1 Home Parenteral Nutrition, Cross-over

EXPERIMENTAL

Random Cycle Sequence - Cycle 1: Clinoleic (baseline), 50g/per day, 42 days Clinoleic + Omegaven, 40g + 10g/per day, 28 days. Cycle 2: Lipoplus (baseline), 50g/per day, 42 days Lipoplus + Omegaven, 40g + 10g/per day, 28 days. Cycle 3: SMOFlipid (baseline), 50g/per day, 42 days SMOFlipid + Omegaven, 40g + 10g/per day, 28 days.

Drug: ClinOleic (baseline); Drug: ClinOleic + Omegaven; Drug: Lipoplus (baseline); Drug: Lipoplus + Omegaven; Drug: SMOFlipid (baseline); Drug: SMOFlipid + Omegaven

2 Home Parenteral Nutrition, Cross-over

ACTIVE COMPARATOR

Random Cycle Sequence - Cycle 1: Clinoleic (baseline), 50g/per day, 42 days Clinoleic + Omegaven, 40g + 10g/per day, 28 days. Cycle 2: Lipoplus (baseline), 50g/per day, 42 days Lipoplus + Omegaven, 40g + 10g/per day, 28 days. Cycle 3: SMOFlipid (baseline), 50g/per day, 42 days SMOFlipid + Omegaven, 40g + 10g/per day, 28 days.

Drug: ClinOleic (baseline); Drug: ClinOleic + Omegaven; Drug: Lipoplus (baseline); Drug: Lipoplus + Omegaven; Drug: SMOFlipid (baseline); Drug: SMOFlipid + Omegaven

Comparator3

NO INTERVENTION

Healthy Control

Interventions

ClinOleic (baseline) DRUG

Lipid emulsion in pharmacy compounded all-in-one admixture

Also known as: ClinOleic 20% Baxter

1 Home Parenteral Nutrition, Cross-over; 2 Home Parenteral Nutrition, Cross-over

ClinOleic + Omegaven DRUG

Lipid emulsion in pharmacy compounded all-in-one admixture

Also known as: ClinOleic 20% Baxter + Omegaven 10% Fresenius Kabi

1 Home Parenteral Nutrition, Cross-over; 2 Home Parenteral Nutrition, Cross-over

Lipoplus (baseline) DRUG

Lipid emulsion in pharmacy compounded all-in-one admixture

Also known as: Lipoplus 20% BBraun Melsungen

1 Home Parenteral Nutrition, Cross-over; 2 Home Parenteral Nutrition, Cross-over

Lipoplus + Omegaven DRUG

Lipid emulsion in pharmacy compounded all-in-one admixture

Also known as: Lipoplus 20% BBraun Melsungen + Omegaven 10% Fresenius Kabi

1 Home Parenteral Nutrition, Cross-over; 2 Home Parenteral Nutrition, Cross-over

SMOFlipid (baseline) DRUG

Lipid emulsion in pharmacy compounded all-in-one admixture

Also known as: SMOFlipid 20% Fresenius Kabi

1 Home Parenteral Nutrition, Cross-over; 2 Home Parenteral Nutrition, Cross-over

SMOFlipid + Omegaven DRUG

Lipid emulsion in pharmacy compounded all-in-one admixture

Also known as: SMOFlipid 20% Fresenius Kabi + Omegaven 10% Fresenius Kabi

1 Home Parenteral Nutrition, Cross-over; 2 Home Parenteral Nutrition, Cross-over

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Home parenteral nutrition patients in need of parenteral nutrition administration \> 4 days/week
• Parenteral duration expectancy \> 8 months
• Stable clinical condition without any complications in the past 2 months
• Written consent from the subject

You may not qualify if:

• Known hypersensitivity to any of the active substances or excipients
• Unstable conditions
• Active cancer or its treatment
• Established immunodeficiency
• Advanced organ dysfunction from chronic disease

Sponsors & Collaborators

• General University Hospital, Prague: lead
• Charles University, Czech Republic: collaborator
• Ministry of Health, Czech Republic: collaborator

Study Sites (1)

General University Hospital

Prague, 12808, Czechia

Location

MeSH Terms

Conditions

Hyperphagia; Intestinal Failure

Interventions

ClinOleic; BaseLine dental cement; fish oil triglycerides; SMOFlipid

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Frantisek Novak, MD, PhD

  General University Hospital, Prague

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: April 11, 2017
• First Posted: May 11, 2017
• Study Start: January 15, 2012
• Primary Completion: January 7, 2016
• Study Completion: June 30, 2016
• Last Updated: May 11, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)