ObstructionPhase 4NCT01943409
Intravenous Nutrition in Hospitalized Patients: Comparison of Two Oils
A Phase 4 study testing Intralipid and ClinOleic in people with Obstruction and Cancer, run by Johane Allard at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstruction, Cancer, Ileus
- What is being tested?
- Intralipid and ClinOleic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 303 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2013to Dec 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- • Patients without PN during their hospitalization
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Parenteral Nutrition in Hospitalized Patients: Comparison of Two Commercially Available Lipid Emulsions
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).
Read the 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.
- Conditions
- Obstruction, Cancer, Ileus, Malnutrition, Surgery
- Being tested
- Intralipid, ClinOleic
- Keywords
- Parenteral nutrition, lipid emulsion, Intralipid, ClinOleic, Inflammation, Infection, Bloodstream Infection, length of stay, mortality
- Medical subject headings
- Bites and Stings, Neoplasms, Ileus, Malnutrition, Hyperphagia, Inflammation, Infections, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IntralipidDrug
soybean oil-based lipid emulsion
ClinOleicDrug
olive oil-based lipid emulsion
| Study group | Role | What they receive |
|---|---|---|
| Intralipid | Active comparator | Patients will receive Intralipid, which is the standard lipid emulsion used in the hospital Receives: Drug: Intralipid |
| ClinOleic | Experimental | 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. Receives: Drug: ClinOleic |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at day 10
Secondary outcomes (8)
Length of Stay
Length of stay in the hospital and ICU will be recorded for 1 year
Measured: 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
Measured: 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
Measured: 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
Measured: at baseline (day 0) and day 10 of PN
Change in Mid-arm Circumference
This is a rough indicator of body fat
Measured: 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
Measured: 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
Measured: 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
Measured: day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2013 (estimated)
- Study startJul 2013
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ObstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 303 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johane Allard
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Johane Allard, University Health Network, Toronto
- Investigators
- Johane P Allard, MD, FRCPC, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01943409
- Sponsor's protocol ID
- CAPCR ID: 13-5807
- Status last verified
- Jan 2025
- First submitted
- 17 Jul 2013
- Last updated
- 3 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parenteral Nutrition in Hospitalized Patients: Comparison of Two Commercially Available Lipid Emulsions
- ClinicalTrials.gov ID
- NCT01943409
- Acronym / sponsor ID
- CAPCR ID: 13-5807
- Conditions
- Obstruction, Cancer, Ileus, Malnutrition, Surgery
- Keywords
- Parenteral nutrition, lipid emulsion, Intralipid, ClinOleic, Inflammation, Infection, Bloodstream Infection, length of stay
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 303 participants (actual)
- Lead sponsor
- Johane AllardUniversity, hospital or other
- Study start
- Jul 2013 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 17 Sep 2013 (estimated)
- Results
- Posted 3 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intralipid | Active comparator | Drug: IntralipidPatients will receive Intralipid, which is the standard lipid emulsion used in the hospital |
| ClinOleic | Experimental | Drug: ClinOleicPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients 18 years or older
Key exclusion criteria (1 listed)
- • Patients without PN during their hospitalization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intralipidsoybean oil-based lipid emulsion | Drug | Intralipid |
| ClinOleicolive oil-based lipid emulsion | Drug | ClinOleic |
Primary outcome
Prealbumin
Time frame: 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.
8 secondary outcomes
Length of Stay
Time frame: participants will be followed for the duration of hospital stay up to one year
Mortality
Time frame: participantes will be followed for the duration of hospital stay for up to 1 year
Infections
Time frame: until one week post-PN up to 1 year
Change in Hand-grip Strength
Time frame: at baseline (day 0) and day 10 of PN
Change in Mid-arm Circumference
Time frame: at baseline (day0) and day 10
Subjective Global Assessment (SGA): Number Who Improved
Time frame: at baseline (day 0) and day 10
Change in High Sensitivity C-reactive Protein (Hs-CRP)
Time frame: Baseline (day 0) and day 10
Red Blood Cell Fatty Acid Composition: Linoleic
Time frame: day 10
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johane P Allard, MD, FRCPC principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intralipid and ClinOleic in people with Obstruction and Cancer, run by Johane Allard at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prealbumin (time frame: at day 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2025.