Intravenous Nutrition in Hospitalized Patients: Comparison of Two Oils
|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|
- 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.
- 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
|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)|
Active Comparator: Intralipid
Patients will receive Intralipid, which is the standard lipid emulsion used in the hospital
soybean oil-based lipid emulsion
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01943409
|Contact: Sultan Alenezi, MScAHNemail@example.com|
|Contact: Bianca M Arendt, PhD, CCRPfirstname.lastname@example.org|
|University Health Network||Recruiting|
|Toronto, Ontario, Canada, M5G 2C4|
|Contact: Sultan Alenezi, MScAHN +1-416-340-4413 email@example.com|
|Contact: Bianca Arendt, PhD, CCRP +1-416-340-4104 firstname.lastname@example.org|
|Principal Investigator:||Johane P Allard, MD, FRCPC||University Health Network, Toronto|