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Intravenous Nutrition in Hospitalized Patients: Comparison of Two Oils

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by University Health Network, Toronto
Sponsor:
Information provided by (Responsible Party):
Johane Allard, University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01943409
First received: July 17, 2013
Last updated: October 24, 2014
Last verified: October 2014
  Purpose

Intravenous nutrition is an important therapy for the recovery of many patients. It is indicated when the patients cannot take food by mouth or use their intestines for feeding. It is important to indicate it in the appropriate setting because it's not free of complications and is a costly treatment. Some of the complications are: elevated blood sugar or lipids, elevated liver function tests, infection of the catheter or device used to administer intravenous nutrition. Intravenous nutrition is composed by proteins, lipids, carbohydrates (sugar in the form of glucose) and vitamins. Until recently, Intralipid, a soybean oil-based lipid emulsion was the only lipid available in Canada for this kind of nutrition. Since 2010, a new lipid emulsion (ClinOleic) based on olive-oil has been approved by Health Canada for use in intravenous nutrition. There is an increasing need for hospitals to evaluate the quality of intravenous nutrition administered to hospitalized patients in terms of: assessing indications, prescription, complications, clinical results and costs. The objective of this study is to determine if intravenous nutrition prescribed in hospitalized patients is indicated following existing guidelines in terms of timing of nutrition support, prescription, monitoring and whether it is associated with complications. In addition, length of stay and mortality will be assessed. Also, we will evaluate nutritional, infectious and inflammatory parameters in patients receiving soybean oil-based lipid emulsion (Intralipid) compared to those of patients receiving olive oil-based lipid emulsion (ClinOleic).


Condition Intervention Phase
Obstruction
Cancer
Ileus
Malnutrition
Surgery
Drug: Intralipid
Drug: ClinOleic
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Parenteral Nutrition in Hospitalized Patients: Comparison of Two Commercially Available Lipid Emulsions

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Length of stay [ Time Frame: participantes will be followed for the duration of hospital stay, an expected average of 4 weeks ] [ Designated as safety issue: No ]
    Length of stay in the hospital and ICU will be recorded. We will record how many days it took,since admission to the hospital, for the patient to be discharged. This is an expected average of 4 weeks of length of stay.


Secondary Outcome Measures:
  • Mortality [ Time Frame: participantes will be followed for the duration of hospital stay, an expected average of 4 weeks ] [ Designated as safety issue: No ]
    We will follow the patients from the day of admission until the day of discharge and record the mortality, if applicable. The expected average of hospital stay is 4 weeks.

  • Body mass index [ Time Frame: Baseline(day 0), day 10 and last day of PN (expected after an average of 3 weeks) ] [ Designated as safety issue: No ]
    We will measure weight before, at day 10 and after PN to calculate the BMI at this different points. The last day of PN is whenever the patient is taken off PN. This can vary considerably from patient to patient.

  • Infections [ Time Frame: until one week post-PN (averag expected 4 weeks) ] [ Designated as safety issue: No ]
    we will record the infections the patients develop during PN until one week after PN

  • hand-grip strength [ Time Frame: at baseline (day 0) and day 10 of PN ] [ Designated as safety issue: No ]
    We will measure hand grip strength at baseline (day0) and at day 10 of PN. This is a test that measures the strength of the hand and forearm muscles and is often used as a general test of strength

  • mid-arm circumference [ Time Frame: at baseline (day0) and day 10 ] [ Designated as safety issue: No ]
    This is a rough indicator of body fat

  • Subjective global assessment (SGA) [ Time Frame: at baseline (day 0) and day 10 ] [ Designated as safety issue: No ]
    is a bedside method that assesses the risk of malnutrition and identifies which patient will benefit best from nutrition support

  • prealbumin [ Time Frame: at baseline (day 0) and day 10 ] [ Designated as safety issue: No ]
    prealbumin is an hepatic protein that is used in the diagnosis of malnutrition. It has a short half-life so any changes in nutritional status can rapidly be represented by prealbumin levels.

  • Antibiotic days [ Time Frame: until one week post PN ] [ Designated as safety issue: No ]
    we will record antibiotic days from the start of PN until one week after PN is discontinued

  • high sensitivity C-reactive Protein (hs-CRP) [ Time Frame: Baseline (day 0) and day 10 ] [ Designated as safety issue: No ]
    hs-CRP is a marker of inflammation, we will measure this parameter at baseline and after 10 days of PN

  • Red blood cell fatty acid composition [ Time Frame: Baseline (day 0) and day 10 ] [ Designated as safety issue: Yes ]
    Red blood cell fatty acid composition, particularly the essential fatty acids (linoleic acid and alpha-linolenic acid) will be measured to assess presence/absence of essential fatty acid deficiency


Estimated Enrollment: 350
Study Start Date: July 2013
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Intralipid
Patients will receive Intralipid, which is the standard lipid emulsion used in the hospital
Drug: Intralipid
soybean oil-based lipid emulsion
Other Name: Intralipid
Experimental: ClinOleic
Patients that are randomized to receive ClinOleic as a lipid emulsion in their PN, instead of Intralipid. ClinOleic is approved by Health Canada. The amount of calories from the lipid emulsion will be equivalent in the standard of care group and in the ClinOleic group.
Drug: ClinOleic
olive oil-based lipid emulsion
Other Name: ClinOleic

Detailed Description:

Until recently, Intralipid, a soybean oil-based lipid emulsion, has been the only available lipid for intravenous use in Canada. In 2010, ClinOleic, a new, predominantly olive oil based emulsion, has been approved by Health Canada as an alternative lipid.

There is an increasing need for hospitals to do quality-assurance studies for in-patient parenteral nutrition (PN) to assess indications, PN prescription, complications, clinical outcomes and costs. The only in-patient population that is well studied is the intensive care unit (ICU) population. Several meta-analyses showed that PN was associated with higher infection rate, longer length of stay and higher mortality when compared with enteral nutrition. Results from these and other studies were the basis for the Canadian ICU Guidelines.

The aim of this study is to determine if PN prescribed in in-patients is indicated, appropriately following existing guidelines in terms of timing of nutrition support, prescription and monitoring and, whether it is associated with complications. In addition, clinical outcomes such as length of stay and mortality will be assessed. Also, we will evaluate metabolic, nutritional, infectious and inflammatory parameters in patients receiving soybean oil-based lipid emulsion compared to those of patients receiving olive oil-based lipid emulsion.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients 18 years or older

    • Patients with PN during their hospitalization
    • Patients hospitalized in medical, surgical or ICU wards
    • Signed informed consent either from the patient, their legally authorized representative or a direct family member

Exclusion Criteria:

  • • Patients without PN during their hospitalization
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01943409

Contacts
Contact: Sultan Alenezi, MScAHN +1-416-340-4413 sultan.alenezi@uhnresearch.ca
Contact: Bianca M Arendt, PhD, CCRP +1-416-340-4104 barendt@uhnresearch.ca

Locations
Canada, Ontario
University Health Network Recruiting
Toronto, Ontario, Canada, M5G 2C4
Contact: Sultan Alenezi, MScAHN    +1-416-340-4413    sultan.alenezi@uhnresearch.ca   
Contact: Bianca Arendt, PhD, CCRP    +1-416-340-4104    barendt@uhnresearch.ca   
Sponsors and Collaborators
Johane Allard
Investigators
Principal Investigator: Johane P Allard, MD, FRCPC University Health Network, Toronto
  More Information

No publications provided

Responsible Party: Johane Allard, Professor of Medicine, Director-Division of Gastroenterology, University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01943409     History of Changes
Other Study ID Numbers: CAPCR ID: 13-5807
Study First Received: July 17, 2013
Last Updated: October 24, 2014
Health Authority: Canada: Health Canada

Keywords provided by University Health Network, Toronto:
Parenteral nutrition
lipid emulsion
Intralipid
ClinOleic
Inflammation
Infection
Bloodstream Infection
length of stay
mortality

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on November 25, 2014