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Intravenous Nutrition in Hospitalized Patients: Comparison of Two Oils

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ClinicalTrials.gov Identifier: NCT01943409
Recruitment Status : Recruiting
First Posted : September 17, 2013
Last Update Posted : December 15, 2017
Sponsor:
Information provided by (Responsible Party):
Johane Allard, University Health Network, Toronto

Brief Summary:
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 or disease Intervention/treatment Phase
Obstruction Cancer Ileus Malnutrition Surgery Drug: Intralipid Drug: ClinOleic Phase 4

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Parenteral Nutrition in Hospitalized Patients: Comparison of Two Commercially Available Lipid Emulsions
Actual Study Start Date : July 2013
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : June 2019

Arm Intervention/treatment
Active Comparator: Intralipid
Patients will receive Intralipid, which is the standard lipid emulsion used in the hospital
Drug: Intralipid
soybean oil-based lipid emulsion

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




Primary Outcome Measures :
  1. Prealbumin [ Time Frame: at baseline (day 0) and day 10 ]
    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.


Secondary Outcome Measures :
  1. Length of stay [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks ]
    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.

  2. Mortality [ Time Frame: participantes will be followed for the duration of hospital stay, an expected average of 4 weeks ]
    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.

  3. Body mass index [ Time Frame: Baseline(day 0), day 10 and last day of PN (expected after an average of 3 weeks) ]
    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.

  4. Infections [ Time Frame: until one week post-PN (averag expected 4 weeks) ]
    we will record the infections the patients develop during PN until one week after PN

  5. hand-grip strength [ Time Frame: at baseline (day 0) and day 10 of PN ]
    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

  6. mid-arm circumference [ Time Frame: at baseline (day0) and day 10 ]
    This is a rough indicator of body fat

  7. Subjective global assessment (SGA) [ Time Frame: at baseline (day 0) and day 10 ]
    is a bedside method that assesses the risk of malnutrition and identifies which patient will benefit best from nutrition support

  8. Antibiotic days [ Time Frame: until one week post PN ]
    we will record antibiotic days from the start of PN until one week after PN is discontinued

  9. high sensitivity C-reactive Protein (hs-CRP) [ Time Frame: Baseline (day 0) and day 10 ]
    hs-CRP is a marker of inflammation, we will measure this parameter at baseline and after 10 days of PN

  10. Red blood cell fatty acid composition [ Time Frame: Baseline (day 0) and day 10 ]
    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



Information from the National Library of Medicine

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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:

  • 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

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): NCT01943409


Contacts
Contact: Sultan Alenezi, MScAHN +1-416-340-4413 sultan.alenezi@uhnresearch.ca
Contact: Monica L Ponta, MD +1-416-340-4413 monica.ponta@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: Monica L Ponta, MD    +1-416-340-4413    monica.ponta@uhnresearch.ca   
Principal Investigator: Johane P Allard, MD         
Sponsors and Collaborators
Johane Allard
Investigators
Principal Investigator: Johane P Allard, MD, FRCPC University Health Network, Toronto
  Study Documents (Full-Text)

Documents provided by Johane Allard, University Health Network, Toronto:

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
First Posted: September 17, 2013    Key Record Dates
Last Update Posted: December 15, 2017
Last Verified: December 2017

Keywords provided by Johane Allard, 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
Soybean oil, phospholipid emulsion
Fat Emulsions, Intravenous
Parenteral Nutrition Solutions
Pharmaceutical Solutions