Comparison of Two Intravenous Lipid Emulsions in Home Parenteral Nutrition Patients

NCT02796833 | Completed Phase 4

• 1 other identifier: 14-8537-A
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Total Parenteral Nutrition (TPN) is a way of feeding a person intravenously, and is required when the gastrointestinal tract is not able to function properly. TPN contains carbohydrates, protein, and fat and lipids. It also contains minerals and vitamins. The lipid that is currently used at the University Health Network home TPN program is Intralipid20%, which is based on Soybean oil, contains polyunsaturated fats and is a good source of energy and essential fatty acids, including omega 3 and 6 fatty acids, which needed by the body. However, long term use on Intralipid20% has been shown to have negative effects on antioxidant status, inflammation, liver, and the immune system. SMOFlipid20% is a lipid emulsion that has been designed to maximize the ratio of omega 3 to omega 6 fatty acids, in an effort to avoid potentially harmful effects associated with Intralipid20%. In previous studies, it has been shown that SMOFlipid20% is safe and has positive benefits on the liver enzymes. There are no studies so far which follow patient who is on SMOFlipid20% long term. The investigators hope to show that with long term use of SMOFlipid20% is better for liver function compared to Intralipid20%.

Conditions

Home Parenteral Nutrition

Keywords

Home parenteral nutrition; Liver injury; Intravenous Lipid Emulsions; Catheter-related infections; Safety

Outcome Measures

Primary Outcomes (1)

• change in alanine transaminase (ALT)

  baseline 1, 6 months, baseline 2 (7 mo), 13 months

Secondary Outcomes (5)

• changes in liver function tests (total and conjugated bilirubin, ALP, AST, GGT)

  baseline 1, 6 months, baseline 2 (7 mo), 13 months

• rate of infections (central line and other) per 1000 catheter days

  baseline 1, 6 months, baseline 2 (7 mo), 13 months

• antibiotic days for acute infections

  baseline 1, 6 months, baseline 2 (7 mo), 13 months

• number of hospitalizations for the past 6 months

  baseline 1, 6 months, 13 months

• number of catheter changes for the past 6 months

  baseline 1, 6 months, 13 months

Study Arms (2)

SMOF/Intralipid

OTHER

Patients that are randomized to receive for the first 6 months SMOF as a lipid emulsion in their PN, and for the next 6 month (after 28 days of active washout on Intralipid) Intralipid, which is the standard lipid emulsion used in the hospital. SMOF is approved by Health Canada. The parenteral nutrition bags are compounded individually for each patient based on their specific needs.

Drug: SMOFlipid20%

Intralipid/SMOF

OTHER

Patients that are randomized to receive Intralipid, which is the standard lipid emulsion used in the hospital for the first 6 months, and for the next 6 month (after 28 days of active washout on Intralipid) SMOF as a lipid emulsion in their PN. SMOF is approved by Health Canada.The parenteral nutrition bags are compounded individually for each patient based on their specific needs.

Drug: SMOFlipid20%

Interventions

SMOFlipid20% DRUG

Intralipid/SMOF; SMOF/Intralipid

Eligibility Criteria

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

You may qualify if:

• Signed and dated informed consent form (ICF) to participate before any study related procedures are performed
• Adult over the age of 18
• Both males and females
• Clinically stable for at least 4 weeks with no acute medical co-morbidities
• Patients on a stable Intralipid HPN regimen for 6 months and expected to require long-term PN for at least 13 more months

You may not qualify if:

• Subjects not already on Intralipid PN Inability to give informed consent Alcohol or drug abuse Pregnant and lactating women
• Clinical instability such as the following:
• Acute pulmonary edema
• Decompensated heart failure
• Decompensated chronic liver disease
• Severe post-traumatic conditions
• Uncontrolled diabetes mellitus
• Acute myocardial infarction
• Acute stroke
• Acute thromboembolism
• Metabolic acidosis
• Sepsis
• Hypotonic dehydration
• Coagulopathy with prolonged aPTT or INR Elevated triglyceride level: more than 4.5 mmol/L Active malignancy with life expectancy less than one year Subjects who are hypersensitive or allergic to the product ingredients of SMOF or Intralipid, including soybean oil, peanuts, fish oil, and egg as well as allergy to peanuts.

Sponsors & Collaborators

• Johane Allard: lead

Study Sites (1)

Toronto General Hospital, University Health Network

Toronto, Ontario, Canada

Location

Related Publications (1)

• Clermont-Dejean NM, Schwenger KJP, Arca C, Somlaw N, Alhanaee A, Hortencio TDR, Jin J, Jung H, Lou W, Ma D, Allard JP. Comparing mixed oil to soybean oil lipid emulsion in patients on home parenteral nutrition: a pilot prospective double-blind, crossover, randomized trial. Pilot Feasibility Stud. 2023 Apr 20;9(1):64. doi: 10.1186/s40814-023-01295-1.

  PMID: 37081524 DERIVED

MeSH Terms

Conditions

Catheter-Related Infections

Condition Hierarchy (Ancestors)

Infections

Study Officials

• Johane Allard, MD, FRCPC

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: June 7, 2016
• First Posted: June 13, 2016
• Study Start: March 1, 2016
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: March 24, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)