Trial Outcomes & Findings for Intravenous Nutrition in Hospitalized Patients: Comparison of Two Oils (NCT NCT01943409)
NCT ID: NCT01943409
Last Updated: 2025-02-03
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
303 participants
Primary outcome timeframe
at day 10
Results posted on
2025-02-03
Participant Flow
Participant milestones
| Measure |
Intralipid
Patients will receive Intralipid, which is the standard lipid emulsion used in the hospital
Intralipid: soybean oil-based lipid emulsion
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
153
|
150
|
|
Overall Study
COMPLETED
|
108
|
102
|
|
Overall Study
NOT COMPLETED
|
45
|
48
|
Reasons for withdrawal
| Measure |
Intralipid
Patients will receive Intralipid, which is the standard lipid emulsion used in the hospital
Intralipid: soybean oil-based lipid emulsion
|
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
|
|---|---|---|
|
Overall Study
resumed oral/entral
|
24
|
20
|
|
Overall Study
Protocol Violation
|
14
|
24
|
|
Overall Study
Death
|
3
|
1
|
|
Overall Study
Withdrawal by Subject
|
4
|
3
|
Baseline Characteristics
These are the baseline characteristics compared between groups
Baseline characteristics by cohort
| Measure |
Baseline Characteristics
n=210 Participants
Baseline Characteristics between Clinoleic and Intralipid
|
|---|---|
|
Age, Continuous
ClinOleic
|
56.81 years
STANDARD_DEVIATION 14.06 • n=102 Participants • These are the baseline characteristics compared between groups
|
|
Age, Continuous
Intralipid
|
57.18 years
STANDARD_DEVIATION 16.43 • n=108 Participants • These are the baseline characteristics compared between groups
|
|
Sex: Female, Male
ClinOleic · Female
|
53 Participants
n=102 Participants • This is the comparison between groups
|
|
Sex: Female, Male
ClinOleic · Male
|
49 Participants
n=102 Participants • This is the comparison between groups
|
|
Sex: Female, Male
Intralipid · Female
|
68 Participants
n=108 Participants • This is the comparison between groups
|
|
Sex: Female, Male
Intralipid · Male
|
40 Participants
n=108 Participants • This is the comparison between groups
|
|
Pre-albumin
Clinoleic
|
0.10 g/l
STANDARD_DEVIATION 0.15 • n=102 Participants • comparison between groups
|
|
Pre-albumin
Intralipid
|
0.11 g/l
STANDARD_DEVIATION 0.16 • n=108 Participants • comparison between groups
|
PRIMARY outcome
Timeframe: at day 10prealbumin 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.
Outcome measures
| Measure |
Intralipid
n=108 Participants
Patients will receive Intralipid, which is the standard lipid emulsion used in the hospital
Intralipid: soybean oil-based lipid emulsion
|
ClinOleic
n=102 Participants
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
|
|---|---|---|
|
Prealbumin
|
0.15 g/l
Standard Deviation 0.08
|
0.16 g/l
Standard Deviation 0.08
|
SECONDARY outcome
Timeframe: participants will be followed for the duration of hospital stay up to one yearLength of stay in the hospital and ICU will be recorded for 1 year
Outcome measures
| Measure |
Intralipid
n=108 Participants
Patients will receive Intralipid, which is the standard lipid emulsion used in the hospital
Intralipid: soybean oil-based lipid emulsion
|
ClinOleic
n=102 Participants
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
|
|---|---|---|
|
Length of Stay
|
45.63 days
Standard Deviation 41.45
|
40.18 days
Standard Deviation 36.60
|
SECONDARY outcome
Timeframe: participantes will be followed for the duration of hospital stay for up to 1 yearWe will follow the patients from the day of admission until the day of discharge and record the mortality for 1 year
Outcome measures
| Measure |
Intralipid
n=108 Participants
Patients will receive Intralipid, which is the standard lipid emulsion used in the hospital
Intralipid: soybean oil-based lipid emulsion
|
ClinOleic
n=102 Participants
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
|
|---|---|---|
|
Mortality
|
11 days
Standard Deviation 10.19
|
13 days
Standard Deviation 12.75
|
SECONDARY outcome
Timeframe: until one week post-PN up to 1 yearwe will record the infections the patients develop during PN until one week after PN for 1 year
Outcome measures
| Measure |
Intralipid
n=108 Participants
Patients will receive Intralipid, which is the standard lipid emulsion used in the hospital
Intralipid: soybean oil-based lipid emulsion
|
ClinOleic
n=102 Participants
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
|
|---|---|---|
|
Infections
|
36 Participants
|
40 Participants
|
SECONDARY outcome
Timeframe: at baseline (day 0) and day 10 of PNWe 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
Outcome measures
| Measure |
Intralipid
n=108 Participants
Patients will receive Intralipid, which is the standard lipid emulsion used in the hospital
Intralipid: soybean oil-based lipid emulsion
|
ClinOleic
n=102 Participants
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
|
|---|---|---|
|
Change in Hand-grip Strength
|
0.10 Kilogram
Standard Deviation 4.97
|
-0.35 Kilogram
Standard Deviation 4.70
|
SECONDARY outcome
Timeframe: at baseline (day0) and day 10This is a rough indicator of body fat
Outcome measures
| Measure |
Intralipid
n=108 Participants
Patients will receive Intralipid, which is the standard lipid emulsion used in the hospital
Intralipid: soybean oil-based lipid emulsion
|
ClinOleic
n=102 Participants
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
|
|---|---|---|
|
Change in Mid-arm Circumference
|
-0.27 cm
Standard Deviation 1.04
|
-0.18 cm
Standard Deviation 1.67
|
SECONDARY outcome
Timeframe: at baseline (day 0) and day 10is a bedside method that assesses the risk of malnutrition and identifies which patient will benefit best from nutrition support
Outcome measures
| Measure |
Intralipid
n=108 Participants
Patients will receive Intralipid, which is the standard lipid emulsion used in the hospital
Intralipid: soybean oil-based lipid emulsion
|
ClinOleic
n=102 Participants
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
|
|---|---|---|
|
Subjective Global Assessment (SGA): Number Who Improved
|
12 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: Baseline (day 0) and day 10hs-CRP is a marker of inflammation, we will measure this parameter at baseline and after 10 days of PN
Outcome measures
| Measure |
Intralipid
n=108 Participants
Patients will receive Intralipid, which is the standard lipid emulsion used in the hospital
Intralipid: soybean oil-based lipid emulsion
|
ClinOleic
n=102 Participants
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
|
|---|---|---|
|
Change in High Sensitivity C-reactive Protein (Hs-CRP)
|
-23.52 mg/dl
Standard Deviation 79.99
|
-29.42 mg/dl
Standard Deviation 70.47
|
SECONDARY outcome
Timeframe: day 10Red 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
Outcome measures
| Measure |
Intralipid
n=108 Participants
Patients will receive Intralipid, which is the standard lipid emulsion used in the hospital
Intralipid: soybean oil-based lipid emulsion
|
ClinOleic
n=102 Participants
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
|
|---|---|---|
|
Red Blood Cell Fatty Acid Composition: Linoleic
|
578.34 ug/ml
Standard Deviation 315.40
|
845.96 ug/ml
Standard Deviation 365.58
|
Adverse Events
Intralipid
Serious events: 0 serious events
Other events: 0 other events
Deaths: 3 deaths
ClinOleic
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Intralipid
n=153 participants at risk
Patients will receive Intralipid, which is the standard lipid emulsion used in the hospital
Intralipid: soybean oil-based lipid emulsion
|
ClinOleic
n=150 participants at risk
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
|
|---|---|---|
|
Infections and infestations
Line infection
|
0.00%
0/153 • Through study completion up to 1 year
|
0.67%
1/150 • Number of events 1 • Through study completion up to 1 year
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place