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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intralipid | Active Comparator | Patients will receive Intralipid, which is the standard lipid emulsion used in the hospital |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intralipid | Drug | soybean oil-based lipid emulsion |
| |
| ClinOleic |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | at day 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Stay | Length of stay in the hospital and ICU will be recorded for 1 year | 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 |
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Inclusion Criteria:
Patients 18 years or older
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Johane P Allard, MD, FRCPC | University Health Network, Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Health Network | Toronto | Ontario | M5G 2C4 | Canada |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intralipid | Patients will receive Intralipid, which is the standard lipid emulsion used in the hospital Intralipid: soybean oil-based lipid emulsion |
| FG001 | 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. ClinOleic: olive oil-based lipid emulsion |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Baseline Characteristics | Baseline Characteristics between Clinoleic and Intralipid |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | These are the baseline characteristics compared between groups |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | g/l | at day 10 |
|
Through study completion up to 1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intralipid | Patients will receive Intralipid, which is the standard lipid emulsion used in the hospital Intralipid: soybean oil-based lipid emulsion |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Line infection | Infections and infestations | Systematic Assessment | Patient was removed from study |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Scientific Associate | Toronto General Hospital | 4163405159 | kschweng@uhnresearch.ca |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 13, 2014 | Nov 1, 2022 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D001733 | Bites and Stings |
| D009369 | Neoplasms |
| D045823 | Ileus |
| D044342 | Malnutrition |
| D006963 | Hyperphagia |
| D007249 | Inflammation |
| D007239 | Infections |
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D011041 | Poisoning |
| D064419 | Chemically-Induced Disorders |
| D014947 | Wounds and Injuries |
| D007415 | Intestinal Obstruction |
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| ID | Term |
|---|---|
| C545823 | soybean oil, phospholipid emulsion |
| C568346 | ClinOleic |
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| Drug |
olive oil-based lipid emulsion |
|
| 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 | 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 | at baseline (day 0) and day 10 of PN |
| Change in Mid-arm Circumference | This is a rough indicator of body fat | 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 | 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 | 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 | day 10 |
| Death |
|
| Withdrawal by Subject |
|
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | This is the comparison between groups | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Pre-albumin | comparison between groups | Mean | Standard Deviation | g/l |
|
|
|
| Secondary | Length of Stay | Length of stay in the hospital and ICU will be recorded for 1 year | Posted | Mean | Standard Deviation | days | participants will be followed for the duration of hospital stay up to one year |
|
|
|
| Secondary | Mortality | We will follow the patients from the day of admission until the day of discharge and record the mortality for 1 year | Posted | Mean | Standard Deviation | days | participantes will be followed for the duration of hospital stay for up to 1 year |
|
|
|
| Secondary | Infections | we will record the infections the patients develop during PN until one week after PN for 1 year | Posted | Count of Participants | Participants | until one week post-PN up to 1 year |
|
|
|
| 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 | Posted | Mean | Standard Deviation | Kilogram | at baseline (day 0) and day 10 of PN |
|
|
|
| Secondary | Change in Mid-arm Circumference | This is a rough indicator of body fat | Posted | Mean | Standard Deviation | cm | at baseline (day0) and day 10 |
|
|
|
| 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 | Posted | Count of Participants | Participants | at baseline (day 0) and day 10 |
|
|
|
| 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 | Posted | Mean | Standard Deviation | mg/dl | Baseline (day 0) and day 10 |
|
|
|
| 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 | Posted | Mean | Standard Deviation | ug/ml | day 10 |
|
|
|
| 3 |
| 153 |
| 0 |
| 153 |
| 0 |
| 153 |
| EG001 | 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. ClinOleic: olive oil-based lipid emulsion | 1 | 150 | 1 | 150 | 0 | 150 |
|
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| D007410 |
| Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |
| D018746 | Systemic Inflammatory Response Syndrome |