- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01943409
Intravenous Nutrition in Hospitalized Patients: Comparison of Two Oils
Parenteral Nutrition in Hospitalized Patients: Comparison of Two Commercially Available Lipid Emulsions
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5G 2C4
- University Health Network
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Intralipid
Patients will receive Intralipid, which is the standard lipid emulsion used in the hospital
|
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.
|
olive oil-based lipid emulsion
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
at baseline (day 0) and day 10
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
participants will be followed for the duration of hospital stay, an expected average of 4 weeks
|
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.
|
participantes will be followed for the duration of hospital stay, an expected average of 4 weeks
|
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.
|
Baseline(day 0), day 10 and last day of PN (expected after an average of 3 weeks)
|
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
|
until one week post-PN (averag expected 4 weeks)
|
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
|
at baseline (day 0) and day 10 of PN
|
mid-arm circumference
Time Frame: at baseline (day0) and day 10
|
This is a rough indicator of body fat
|
at baseline (day0) and day 10
|
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
|
at baseline (day 0) and day 10
|
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
|
until one week post PN
|
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
|
Baseline (day 0) and day 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
|
Baseline (day 0) and day 10
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CAPCR ID: 13-5807
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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