Cancer, Ileus, Malnutrition, Obstruction, Surgery
Conditions
Keywords
Parenteral nutrition, lipid emulsion, Intralipid, ClinOleic, Inflammation, Infection, Bloodstream Infection, length of stay, mortality
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).
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.
Interventions
DRUGIntralipid
soybean oil-based lipid emulsion
DRUGClinOleic
olive oil-based lipid emulsion
Sponsors
Johane Allard
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prealbumin | at 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
| Measure | Time frame | Description |
|---|---|---|
| Mortality | participantes will be followed for the duration of hospital stay for up to 1 year | We will follow the patients from the day of admission until the day of discharge and record the mortality for 1 year |
| Infections | until one week post-PN up to 1 year | we will record the infections the patients develop during PN until one week after PN for 1 year |
| Change in Hand-grip Strength | 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 |
| Length of Stay | participants will be followed for the duration of hospital stay up to one year | Length of stay in the hospital and ICU will be recorded for 1 year |
| Subjective Global Assessment (SGA): Number Who Improved | 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 |
| Change in High Sensitivity C-reactive Protein (Hs-CRP) | 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 |
| Red Blood Cell Fatty Acid Composition: Linoleic | 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 |
| Change in Mid-arm Circumference | at baseline (day0) and day 10 | This is a rough indicator of body fat |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Baseline Characteristics Baseline Characteristics between Clinoleic and Intralipid | 210 |
| Total | 210 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 3 | 1 |
| Overall Study | Protocol Violation | 14 | 24 |
| Overall Study | resumed oral/entral | 24 | 20 |
| Overall Study | Withdrawal by Subject | 4 | 3 |
Baseline characteristics
| Characteristic | Baseline Characteristics | — |
|---|---|---|
| Age, Continuous ClinOleic | 56.81 years STANDARD_DEVIATION 14.06 | — |
| Age, Continuous Intralipid | 57.18 years STANDARD_DEVIATION 16.43 | — |
| Pre-albumin Clinoleic | 0.10 g/l STANDARD_DEVIATION 0.15 | — |
| Pre-albumin Intralipid | 0.11 g/l STANDARD_DEVIATION 0.16 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male ClinOleic Female | 53 Participants | — |
| Sex: Female, Male ClinOleic Male | 49 Participants | — |
| Sex: Female, Male Intralipid Female | 68 Participants | — |
| Sex: Female, Male Intralipid Male | 40 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 153 | 1 / 150 |
| other Total, other adverse events | 0 / 153 | 0 / 150 |
| serious Total, serious adverse events | 0 / 153 | 1 / 150 |
Outcome results
Primary
Prealbumin
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.
Time frame: at day 10
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intralipid | Prealbumin | 0.15 g/l | Standard Deviation 0.08 |
| ClinOleic | Prealbumin | 0.16 g/l | Standard Deviation 0.08 |
Secondary
Change in Hand-grip Strength
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
Time frame: at baseline (day 0) and day 10 of PN
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intralipid | Change in Hand-grip Strength | 0.10 Kilogram | Standard Deviation 4.97 |
| ClinOleic | Change in Hand-grip Strength | -0.35 Kilogram | Standard Deviation 4.7 |
Secondary
Change in High Sensitivity C-reactive Protein (Hs-CRP)
hs-CRP is a marker of inflammation, we will measure this parameter at baseline and after 10 days of PN
Time frame: Baseline (day 0) and day 10
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intralipid | Change in High Sensitivity C-reactive Protein (Hs-CRP) | -23.52 mg/dl | Standard Deviation 79.99 |
| ClinOleic | Change in High Sensitivity C-reactive Protein (Hs-CRP) | -29.42 mg/dl | Standard Deviation 70.47 |
Secondary
Change in Mid-arm Circumference
This is a rough indicator of body fat
Time frame: at baseline (day0) and day 10
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intralipid | Change in Mid-arm Circumference | -0.27 cm | Standard Deviation 1.04 |
| ClinOleic | Change in Mid-arm Circumference | -0.18 cm | Standard Deviation 1.67 |
Secondary
Infections
we will record the infections the patients develop during PN until one week after PN for 1 year
Time frame: until one week post-PN up to 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intralipid | Infections | 36 Participants |
| ClinOleic | Infections | 40 Participants |
Secondary
Length of Stay
Length of stay in the hospital and ICU will be recorded for 1 year
Time frame: participants will be followed for the duration of hospital stay up to one year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intralipid | Length of Stay | 45.63 days | Standard Deviation 41.45 |
| ClinOleic | Length of Stay | 40.18 days | Standard Deviation 36.6 |
Secondary
Mortality
We will follow the patients from the day of admission until the day of discharge and record the mortality for 1 year
Time frame: participantes will be followed for the duration of hospital stay for up to 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intralipid | Mortality | 11 days | Standard Deviation 10.19 |
| ClinOleic | Mortality | 13 days | Standard Deviation 12.75 |
Secondary
Red Blood Cell Fatty Acid Composition: Linoleic
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
Time frame: day 10
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intralipid | Red Blood Cell Fatty Acid Composition: Linoleic | 578.34 ug/ml | Standard Deviation 315.4 |
| ClinOleic | Red Blood Cell Fatty Acid Composition: Linoleic | 845.96 ug/ml | Standard Deviation 365.58 |
Secondary
Subjective Global Assessment (SGA): Number Who Improved
is a bedside method that assesses the risk of malnutrition and identifies which patient will benefit best from nutrition support
Time frame: at baseline (day 0) and day 10
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intralipid | Subjective Global Assessment (SGA): Number Who Improved | 12 Participants |
| ClinOleic | Subjective Global Assessment (SGA): Number Who Improved | 15 Participants |