A Phase 4 interventional study of Intralipid and ClinOleic in Obstruction, Cancer and Ileus, sponsored by Johane Allard. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-03.
Sponsored by Johane Allard · Phase 4, Interventional, and Supportive care
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).
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.
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Patients 18 years or older
Exclusion Criteria:
Patients will receive Intralipid, which is the standard lipid emulsion used in the hospital
Drug: Intralipid
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
soybean oil-based lipid emulsion
olive oil-based lipid emulsion
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
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
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
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
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
Change in Mid-arm Circumference
This is a rough indicator of body fat
Time frame: at baseline (day0) and day 10
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
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
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
| Milestone | Intralipid | ClinOleic |
|---|---|---|
| Started | 153 | 150 |
| Completed | 108 | 102 |
| Not completed | 45 | 48 |
| Withdrew: Resumed oral/entral | 24 | 20 |
| Withdrew: Protocol violation | 14 | 24 |
| Withdrew: Death | 3 | 1 |
| Withdrew: Withdrawal by subject | 4 | 3 |
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.
| g/l | Intralipid | ClinOleic |
|---|---|---|
| Prealbumin | 0.15 ± 0.08 | 0.16 ± 0.08 |
Length of stay in the hospital and ICU will be recorded for 1 year
| days | Intralipid | ClinOleic |
|---|---|---|
| Length of Stay | 45.63 ± 41.45 | 40.18 ± 36.60 |
We will follow the patients from the day of admission until the day of discharge and record the mortality for 1 year
| days | Intralipid | ClinOleic |
|---|---|---|
| Mortality | 11 ± 10.19 | 13 ± 12.75 |
we will record the infections the patients develop during PN until one week after PN for 1 year
| Participants | Intralipid | ClinOleic |
|---|---|---|
| Infections | 36 | 40 |
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
| Kilogram | Intralipid | ClinOleic |
|---|---|---|
| Change in Hand-grip Strength | 0.10 ± 4.97 | -0.35 ± 4.70 |
This is a rough indicator of body fat
| cm | Intralipid | ClinOleic |
|---|---|---|
| Change in Mid-arm Circumference | -0.27 ± 1.04 | -0.18 ± 1.67 |
is a bedside method that assesses the risk of malnutrition and identifies which patient will benefit best from nutrition support
| Participants | Intralipid | ClinOleic |
|---|---|---|
| Subjective Global Assessment (SGA): Number Who Improved | 12 | 15 |
hs-CRP is a marker of inflammation, we will measure this parameter at baseline and after 10 days of PN
| mg/dl | Intralipid | ClinOleic |
|---|---|---|
| Change in High Sensitivity C-reactive Protein (Hs-CRP) | -23.52 ± 79.99 | -29.42 ± 70.47 |
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
| ug/ml | Intralipid | ClinOleic |
|---|---|---|
| Red Blood Cell Fatty Acid Composition: Linoleic | 578.34 ± 315.40 | 845.96 ± 365.58 |
Collected over Through study completion up to 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intralipid | 3/153 (2%) | 0/153 (0%) | 0/153 (0%) |
| ClinOleic | 1/150 (0.7%) | 1/150 (0.7%) | 0/150 (0%) |
| Event | Intralipid | ClinOleic |
|---|---|---|
| Line infectionInfections and infestations | — | 1/150 |
| Age, Continuous(years) | Baseline Characteristics |
|---|---|
| ClinOleic | 56.81 ± 14.06 |
| Intralipid | 57.18 ± 16.43 |
| Sex: Female, Male(Participants) | Baseline Characteristics |
|---|---|
| ClinOleic — Female | 53 |
| ClinOleic — Male | 49 |
| Intralipid — Female | 68 |
| Intralipid — Male | 40 |
| Race and Ethnicity Not Collected(Participants) | Baseline Characteristics |
|---|
| Pre-albumin(g/l) | Baseline Characteristics |
|---|---|
| Clinoleic | 0.10 ± 0.15 |
| Intralipid | 0.11 ± 0.16 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
Ran from Jul 2013 to primary completion in Dec 2019, 77 months.
Results were first posted in Feb 2025, 5 years 2 months after primary completion.
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Studies of the drug tested here: ClinOleic
Johane Allard