Trial Outcomes & Findings for Trial of Supplemental Parenteral Nutrition in Under and Over Weight Critically Ill Patients (TOP-UP) (NCT NCT01206166)

NCT ID: NCT01206166

Last Updated: 2021-03-16

Results Overview

Amount of calories \& protein received as a percentage of prescribed.

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 125 participants
• Primary outcome timeframe: 7 days post randomization
• Results posted on: 2021-03-16

Participant Flow

Participant milestones

Measure	Enteral Nutrition + Parenteral Nutrition Enteral nutrition with the addition of parenteral supplementation (Olimel 5.7%E/N9E). Olimel (5.7%E / N9E): OLIMEL(Amino Acids, Dextrose, Lipids, with / without Electrolytes) is indicated for parenteral nutrition for adults when oral or enteral nutrition is impossible, insufficient or contraindicated.	Enteral Nutrition Only Enteral nutrition only - no intervention
Overall Study STARTED	73	52
Overall Study COMPLETED	71	49
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Measure	Enteral Nutrition + Parenteral Nutrition Enteral nutrition with the addition of parenteral supplementation (Olimel 5.7%E/N9E). Olimel (5.7%E / N9E): OLIMEL(Amino Acids, Dextrose, Lipids, with / without Electrolytes) is indicated for parenteral nutrition for adults when oral or enteral nutrition is impossible, insufficient or contraindicated.	Enteral Nutrition Only Enteral nutrition only - no intervention
Overall Study No evaluable data	2	3

Baseline Characteristics

Trial of Supplemental Parenteral Nutrition in Under and Over Weight Critically Ill Patients (TOP-UP)

Baseline characteristics by cohort

Measure	Enteral Nutrition + Parenteral Nutrition n=73 Participants Enteral nutrition with the addition of parenteral supplementation (Olimel 5.7%E/N9E). Olimel (5.7%E / N9E): OLIMEL(Amino Acids, Dextrose, Lipids, with / without Electrolytes) is indicated for parenteral nutrition for adults when oral or enteral nutrition is impossible, insufficient or contraindicated.	Enteral Nutrition Only n=52 Participants Enteral nutrition only - no intervention	Total n=125 Participants Total of all reporting groups
Age, Continuous	55.1 years STANDARD_DEVIATION 16.2 • n=5 Participants	55.8 years STANDARD_DEVIATION 19.8 • n=7 Participants	55.45 years STANDARD_DEVIATION 18 • n=5 Participants
Sex: Female, Male Female	34 Participants n=5 Participants	31 Participants n=7 Participants	65 Participants n=5 Participants
Sex: Female, Male Male	39 Participants n=5 Participants	21 Participants n=7 Participants	60 Participants n=5 Participants
Race/Ethnicity, Customized White	65 Participants n=5 Participants	46 Participants n=7 Participants	111 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Pacific Islander	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Native	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized unknown/unreported	0 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: 7 days post randomization

Population: ICU patients

Amount of calories & protein received as a percentage of prescribed.

Outcome measures

Measure	EN Only n=71 Participants Enteral nutrition no intervention	Enteral Nutrition + Parenteral Nutrition n=49 Participants Enteral nutrition with the addition of parenteral supplementation (Olimel 5.7%E/N9E). Olimel (5.7%E / N9E): OLIMEL(Amino Acids, Dextrose, Lipids, with / without Electrolytes) is indicated for parenteral nutrition for adults when oral or enteral nutrition is impossible, insufficient or contraindicated.
Calorie & Protein Intake 7 Days Post Randomization calories in first 7 days	69 percentage of prescribed Standard Deviation 28	95 percentage of prescribed Standard Deviation 13
Calorie & Protein Intake 7 Days Post Randomization protein in first 7 days	64 percentage of prescribed Standard Deviation 26	86 percentage of prescribed Standard Deviation 16

PRIMARY outcome

Timeframe: first 27 days

Population: ICU patients

Amount of calories & protein received as a percentage of prescribed.

Outcome measures

Measure	EN Only n=71 Participants Enteral nutrition no intervention	Enteral Nutrition + Parenteral Nutrition n=49 Participants Enteral nutrition with the addition of parenteral supplementation (Olimel 5.7%E/N9E). Olimel (5.7%E / N9E): OLIMEL(Amino Acids, Dextrose, Lipids, with / without Electrolytes) is indicated for parenteral nutrition for adults when oral or enteral nutrition is impossible, insufficient or contraindicated.
Calorie & Protein Intake in First 27 Days calories in first 27 days	72 percentage of prescribed Standard Deviation 25	90 percentage of prescribed Standard Deviation 16
Calorie & Protein Intake in First 27 Days protein in first 27 days	68 percentage of prescribed Standard Deviation 25	82 percentage of prescribed Standard Deviation 19

SECONDARY outcome

Timeframe: 6 months

Kaplan-Meier estimate.

Outcome measures

Measure	EN Only n=73 Participants Enteral nutrition no intervention	Enteral Nutrition + Parenteral Nutrition n=52 Participants Enteral nutrition with the addition of parenteral supplementation (Olimel 5.7%E/N9E). Olimel (5.7%E / N9E): OLIMEL(Amino Acids, Dextrose, Lipids, with / without Electrolytes) is indicated for parenteral nutrition for adults when oral or enteral nutrition is impossible, insufficient or contraindicated.
6 Month Mortality	27.5 percentage of participants	29.5 percentage of participants

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Measure	EN Only n=73 Participants Enteral nutrition no intervention	Enteral Nutrition + Parenteral Nutrition n=52 Participants Enteral nutrition with the addition of parenteral supplementation (Olimel 5.7%E/N9E). Olimel (5.7%E / N9E): OLIMEL(Amino Acids, Dextrose, Lipids, with / without Electrolytes) is indicated for parenteral nutrition for adults when oral or enteral nutrition is impossible, insufficient or contraindicated.
ICU Mortality	13 Participants	7 Participants

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Measure	EN Only n=73 Participants Enteral nutrition no intervention	Enteral Nutrition + Parenteral Nutrition n=52 Participants Enteral nutrition with the addition of parenteral supplementation (Olimel 5.7%E/N9E). Olimel (5.7%E / N9E): OLIMEL(Amino Acids, Dextrose, Lipids, with / without Electrolytes) is indicated for parenteral nutrition for adults when oral or enteral nutrition is impossible, insufficient or contraindicated.
Hospital Mortality	17 Participants	8 Participants

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Measure	EN Only n=73 Participants Enteral nutrition no intervention	Enteral Nutrition + Parenteral Nutrition n=52 Participants Enteral nutrition with the addition of parenteral supplementation (Olimel 5.7%E/N9E). Olimel (5.7%E / N9E): OLIMEL(Amino Acids, Dextrose, Lipids, with / without Electrolytes) is indicated for parenteral nutrition for adults when oral or enteral nutrition is impossible, insufficient or contraindicated.
Duration of ICU Stay	12.6 days Interval 8.1 to 18.7	12.8 days Interval 7.9 to 17.8

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Measure	EN Only n=73 Participants Enteral nutrition no intervention	Enteral Nutrition + Parenteral Nutrition n=52 Participants Enteral nutrition with the addition of parenteral supplementation (Olimel 5.7%E/N9E). Olimel (5.7%E / N9E): OLIMEL(Amino Acids, Dextrose, Lipids, with / without Electrolytes) is indicated for parenteral nutrition for adults when oral or enteral nutrition is impossible, insufficient or contraindicated.
Duration of Hospital Stay	24 days Interval 16.6 to 38.9	23.5 days Interval 17.5 to 34.7

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Measure	EN Only n=73 Participants Enteral nutrition no intervention	Enteral Nutrition + Parenteral Nutrition n=52 Participants Enteral nutrition with the addition of parenteral supplementation (Olimel 5.7%E/N9E). Olimel (5.7%E / N9E): OLIMEL(Amino Acids, Dextrose, Lipids, with / without Electrolytes) is indicated for parenteral nutrition for adults when oral or enteral nutrition is impossible, insufficient or contraindicated.
Duration of Mechanical Ventilation	8.3 days Interval 3.8 to 13.3	6.5 days Interval 3.9 to 14.1

SECONDARY outcome

Timeframe: ICU discharge

Outcome measures

Measure	EN Only n=73 Participants Enteral nutrition no intervention	Enteral Nutrition + Parenteral Nutrition n=52 Participants Enteral nutrition with the addition of parenteral supplementation (Olimel 5.7%E/N9E). Olimel (5.7%E / N9E): OLIMEL(Amino Acids, Dextrose, Lipids, with / without Electrolytes) is indicated for parenteral nutrition for adults when oral or enteral nutrition is impossible, insufficient or contraindicated.
Development of ICU-acquired Infections	23 Participants	14 Participants

SECONDARY outcome

Timeframe: 3 months

The SF-36 physical function domain ranges from 0-100. Higher scores indicate better outcome.

Outcome measures

Measure	EN Only n=73 Participants Enteral nutrition no intervention	Enteral Nutrition + Parenteral Nutrition n=52 Participants Enteral nutrition with the addition of parenteral supplementation (Olimel 5.7%E/N9E). Olimel (5.7%E / N9E): OLIMEL(Amino Acids, Dextrose, Lipids, with / without Electrolytes) is indicated for parenteral nutrition for adults when oral or enteral nutrition is impossible, insufficient or contraindicated.
SF36-Physical Functioning Domain	39.4 score on a scale Standard Deviation 34.3	34.8 score on a scale Standard Deviation 31.5

SECONDARY outcome

Timeframe: 6 months

The SF-36 physical function domain ranges from 0-100. Higher scores indicate better outcome.

Outcome measures

Measure	EN Only n=73 Participants Enteral nutrition no intervention	Enteral Nutrition + Parenteral Nutrition n=52 Participants Enteral nutrition with the addition of parenteral supplementation (Olimel 5.7%E/N9E). Olimel (5.7%E / N9E): OLIMEL(Amino Acids, Dextrose, Lipids, with / without Electrolytes) is indicated for parenteral nutrition for adults when oral or enteral nutrition is impossible, insufficient or contraindicated.
SF-36 Physical Functioning Domain	39.3 score on a scale Standard Deviation 34	50.8 score on a scale Standard Deviation 36.5

SECONDARY outcome

Timeframe: hospital discharge

Outcome measures

Measure	EN Only n=73 Participants Enteral nutrition no intervention	Enteral Nutrition + Parenteral Nutrition n=52 Participants Enteral nutrition with the addition of parenteral supplementation (Olimel 5.7%E/N9E). Olimel (5.7%E / N9E): OLIMEL(Amino Acids, Dextrose, Lipids, with / without Electrolytes) is indicated for parenteral nutrition for adults when oral or enteral nutrition is impossible, insufficient or contraindicated.
Functional Status at Hospital Discharge hand grip · Pt died	17 Participants	8 Participants
Functional Status at Hospital Discharge hand grip · Unable to do	12 Participants	5 Participants
Functional Status at Hospital Discharge hand grip · Refused to do	3 Participants	3 Participants
Functional Status at Hospital Discharge hand grip · Done	22 Participants	17 Participants
Functional Status at Hospital Discharge hand grip · Missed	16 Participants	12 Participants
Functional Status at Hospital Discharge hand grip · Unknown reason	1 Participants	4 Participants
Functional Status at Hospital Discharge hand grip · use ICU	2 Participants	3 Participants
Functional Status at Hospital Discharge 6min walk test · Pt died	17 Participants	8 Participants
Functional Status at Hospital Discharge 6min walk test · Unable to do	31 Participants	20 Participants
Functional Status at Hospital Discharge 6min walk test · Refused to do	3 Participants	3 Participants
Functional Status at Hospital Discharge 6min walk test · Done	9 Participants	9 Participants
Functional Status at Hospital Discharge 6min walk test · Missed	12 Participants	9 Participants
Functional Status at Hospital Discharge 6min walk test · Unknown reason	1 Participants	3 Participants
Functional Status at Hospital Discharge 6min walk test · use ICU	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 3 months

The SF-36 role physical function domain ranges from 0-100. Higher scores indicate better outcome.

Outcome measures

Measure	EN Only n=73 Participants Enteral nutrition no intervention	Enteral Nutrition + Parenteral Nutrition n=52 Participants Enteral nutrition with the addition of parenteral supplementation (Olimel 5.7%E/N9E). Olimel (5.7%E / N9E): OLIMEL(Amino Acids, Dextrose, Lipids, with / without Electrolytes) is indicated for parenteral nutrition for adults when oral or enteral nutrition is impossible, insufficient or contraindicated.
SF36 Role Physical Domain	30.2 score on a scale Standard Deviation 31.8	32.8 score on a scale Standard Deviation 32.6

SECONDARY outcome

Timeframe: 3 months

The SF-36 pain index domain ranges from 0-100. Higher scores indicate better outcome.

Outcome measures

Measure	EN Only n=73 Participants Enteral nutrition no intervention	Enteral Nutrition + Parenteral Nutrition n=52 Participants Enteral nutrition with the addition of parenteral supplementation (Olimel 5.7%E/N9E). Olimel (5.7%E / N9E): OLIMEL(Amino Acids, Dextrose, Lipids, with / without Electrolytes) is indicated for parenteral nutrition for adults when oral or enteral nutrition is impossible, insufficient or contraindicated.
SF36 Pain Index Domain	59.1 score on a scale Standard Deviation 28.8	66.4 score on a scale Standard Deviation 27.3

SECONDARY outcome

Timeframe: 3 months

The SF-36 general health perceptions domain ranges from 0-100. Higher scores indicate better outcome.

Outcome measures

Measure	EN Only n=73 Participants Enteral nutrition no intervention	Enteral Nutrition + Parenteral Nutrition n=52 Participants Enteral nutrition with the addition of parenteral supplementation (Olimel 5.7%E/N9E). Olimel (5.7%E / N9E): OLIMEL(Amino Acids, Dextrose, Lipids, with / without Electrolytes) is indicated for parenteral nutrition for adults when oral or enteral nutrition is impossible, insufficient or contraindicated.
SF36 General Health Perceptions Domain	61.2 score on a scale Standard Deviation 18.3	49.5 score on a scale Standard Deviation 24.3

SECONDARY outcome

Timeframe: 3 months

The SF-36 vitality domain ranges from 0-100. Higher scores indicate better outcome.

Outcome measures

Measure	EN Only n=73 Participants Enteral nutrition no intervention	Enteral Nutrition + Parenteral Nutrition n=52 Participants Enteral nutrition with the addition of parenteral supplementation (Olimel 5.7%E/N9E). Olimel (5.7%E / N9E): OLIMEL(Amino Acids, Dextrose, Lipids, with / without Electrolytes) is indicated for parenteral nutrition for adults when oral or enteral nutrition is impossible, insufficient or contraindicated.
SF36 Vitality Domain	52.8 score on a scale Standard Deviation 21.4	51 score on a scale Standard Deviation 21.7

SECONDARY outcome

Timeframe: 3 months

The SF-36 social functioning domain ranges from 0-100. Higher scores indicate better outcome.

Outcome measures

Measure	EN Only n=73 Participants Enteral nutrition no intervention	Enteral Nutrition + Parenteral Nutrition n=52 Participants Enteral nutrition with the addition of parenteral supplementation (Olimel 5.7%E/N9E). Olimel (5.7%E / N9E): OLIMEL(Amino Acids, Dextrose, Lipids, with / without Electrolytes) is indicated for parenteral nutrition for adults when oral or enteral nutrition is impossible, insufficient or contraindicated.
SF36 Social Functioning Domain	60.4 score on a scale Standard Deviation 31.8	56.5 score on a scale Standard Deviation 28.2

SECONDARY outcome

Timeframe: 3 months

The SF-36 role-emotion domain ranges from 0-100. Higher scores indicate better outcome.

Outcome measures

Measure	EN Only n=73 Participants Enteral nutrition no intervention	Enteral Nutrition + Parenteral Nutrition n=52 Participants Enteral nutrition with the addition of parenteral supplementation (Olimel 5.7%E/N9E). Olimel (5.7%E / N9E): OLIMEL(Amino Acids, Dextrose, Lipids, with / without Electrolytes) is indicated for parenteral nutrition for adults when oral or enteral nutrition is impossible, insufficient or contraindicated.
SF36 Role-emotional Domain	63.2 score on a scale Standard Deviation 34.6	65.3 score on a scale Standard Deviation 34.4

SECONDARY outcome

Timeframe: 3 months

The SF-36 mental health index domain ranges from 0-100. Higher scores indicate better outcome.

Outcome measures

Measure	EN Only n=73 Participants Enteral nutrition no intervention	Enteral Nutrition + Parenteral Nutrition n=52 Participants Enteral nutrition with the addition of parenteral supplementation (Olimel 5.7%E/N9E). Olimel (5.7%E / N9E): OLIMEL(Amino Acids, Dextrose, Lipids, with / without Electrolytes) is indicated for parenteral nutrition for adults when oral or enteral nutrition is impossible, insufficient or contraindicated.
SF36 Mental Health Index Domain	72.9 score on a scale Standard Deviation 18.7	76.1 score on a scale Standard Deviation 18.5

SECONDARY outcome

Timeframe: 3 months

The SF36 Standardized Physical Component Scale has been scaled to have a mean of zero and standard deviation of 10 in a general US population. Higher scores indicate better HRQoL.

Outcome measures

Measure	EN Only n=73 Participants Enteral nutrition no intervention	Enteral Nutrition + Parenteral Nutrition n=52 Participants Enteral nutrition with the addition of parenteral supplementation (Olimel 5.7%E/N9E). Olimel (5.7%E / N9E): OLIMEL(Amino Acids, Dextrose, Lipids, with / without Electrolytes) is indicated for parenteral nutrition for adults when oral or enteral nutrition is impossible, insufficient or contraindicated.
SF36 Standardized Physical Component Scale	35.3 score on a scale Standard Deviation 10.8	33.3 score on a scale Standard Deviation 10.1

SECONDARY outcome

Timeframe: 3 months

The SF36 Standardized Mental Component Scale has been scaled to have a mean of zero and standard deviation of 10 in a general US population. Higher scores indicate better HRQoL.

Outcome measures

Measure	EN Only n=73 Participants Enteral nutrition no intervention	Enteral Nutrition + Parenteral Nutrition n=52 Participants Enteral nutrition with the addition of parenteral supplementation (Olimel 5.7%E/N9E). Olimel (5.7%E / N9E): OLIMEL(Amino Acids, Dextrose, Lipids, with / without Electrolytes) is indicated for parenteral nutrition for adults when oral or enteral nutrition is impossible, insufficient or contraindicated.
SF36 Standardized Mental Component Scale	50 score on a scale Standard Deviation 10.5	51.5 score on a scale Standard Deviation 10

SECONDARY outcome

Timeframe: 6 months

The SF-36 mental health index domain ranges from 0-100. Higher scores indicate better outcome.

Outcome measures

Measure	EN Only n=73 Participants Enteral nutrition no intervention	Enteral Nutrition + Parenteral Nutrition n=52 Participants Enteral nutrition with the addition of parenteral supplementation (Olimel 5.7%E/N9E). Olimel (5.7%E / N9E): OLIMEL(Amino Acids, Dextrose, Lipids, with / without Electrolytes) is indicated for parenteral nutrition for adults when oral or enteral nutrition is impossible, insufficient or contraindicated.
SF-36 Role-physical Domain	40.2 score on a scale Standard Deviation 33.1	47.5 score on a scale Standard Deviation 33.4

SECONDARY outcome

Timeframe: 6 months

The SF-36 mental health index domain ranges from 0-100. Higher scores indicate better outcome.

Outcome measures

Measure	EN Only n=73 Participants Enteral nutrition no intervention	Enteral Nutrition + Parenteral Nutrition n=52 Participants Enteral nutrition with the addition of parenteral supplementation (Olimel 5.7%E/N9E). Olimel (5.7%E / N9E): OLIMEL(Amino Acids, Dextrose, Lipids, with / without Electrolytes) is indicated for parenteral nutrition for adults when oral or enteral nutrition is impossible, insufficient or contraindicated.
SF-36 Pain Index Domain	52.5 score on a scale Standard Deviation 31	68.6 score on a scale Standard Deviation 28.2

SECONDARY outcome

Timeframe: 6 months

The SF-36 general health perceptions domain ranges from 0-100. Higher scores indicate better outcome.

Outcome measures

Measure	EN Only n=73 Participants Enteral nutrition no intervention	Enteral Nutrition + Parenteral Nutrition n=52 Participants Enteral nutrition with the addition of parenteral supplementation (Olimel 5.7%E/N9E). Olimel (5.7%E / N9E): OLIMEL(Amino Acids, Dextrose, Lipids, with / without Electrolytes) is indicated for parenteral nutrition for adults when oral or enteral nutrition is impossible, insufficient or contraindicated.
SF-36 General Health Perceptions Domain	50.9 score on a scale Standard Deviation 20.6	56.8 score on a scale Standard Deviation 26.2

SECONDARY outcome

Timeframe: 6 months

The SF-36 vitality domain ranges from 0-100. Higher scores indicate better outcome.

Outcome measures

Measure	EN Only n=73 Participants Enteral nutrition no intervention	Enteral Nutrition + Parenteral Nutrition n=52 Participants Enteral nutrition with the addition of parenteral supplementation (Olimel 5.7%E/N9E). Olimel (5.7%E / N9E): OLIMEL(Amino Acids, Dextrose, Lipids, with / without Electrolytes) is indicated for parenteral nutrition for adults when oral or enteral nutrition is impossible, insufficient or contraindicated.
SF-36 Vitality Domain	47.8 score on a scale Standard Deviation 21.2	59.1 score on a scale Standard Deviation 21.7

SECONDARY outcome

Timeframe: 6 months

The SF-36 social functioning domain ranges from 0-100. Higher scores indicate better outcome.

Outcome measures

Measure	EN Only n=73 Participants Enteral nutrition no intervention	Enteral Nutrition + Parenteral Nutrition n=52 Participants Enteral nutrition with the addition of parenteral supplementation (Olimel 5.7%E/N9E). Olimel (5.7%E / N9E): OLIMEL(Amino Acids, Dextrose, Lipids, with / without Electrolytes) is indicated for parenteral nutrition for adults when oral or enteral nutrition is impossible, insufficient or contraindicated.
SF-36 Social Functioning Domain	50.4 score on a scale Standard Deviation 32.2	68.8 score on a scale Standard Deviation 32.6

SECONDARY outcome

Timeframe: 6 months

The SF-36 role-emotional domain ranges from 0-100. Higher scores indicate better outcome.

Outcome measures

Measure	EN Only n=73 Participants Enteral nutrition no intervention	Enteral Nutrition + Parenteral Nutrition n=52 Participants Enteral nutrition with the addition of parenteral supplementation (Olimel 5.7%E/N9E). Olimel (5.7%E / N9E): OLIMEL(Amino Acids, Dextrose, Lipids, with / without Electrolytes) is indicated for parenteral nutrition for adults when oral or enteral nutrition is impossible, insufficient or contraindicated.
SF-36 Role-emotional Domain	52.2 score on a scale Standard Deviation 41	72.1 score on a scale Standard Deviation 30.3

SECONDARY outcome

Timeframe: 6 months

The SF-36 mental health index domain ranges from 0-100. Higher scores indicate better outcome.

Outcome measures

Measure	EN Only n=73 Participants Enteral nutrition no intervention	Enteral Nutrition + Parenteral Nutrition n=52 Participants Enteral nutrition with the addition of parenteral supplementation (Olimel 5.7%E/N9E). Olimel (5.7%E / N9E): OLIMEL(Amino Acids, Dextrose, Lipids, with / without Electrolytes) is indicated for parenteral nutrition for adults when oral or enteral nutrition is impossible, insufficient or contraindicated.
SF-36 Mental Health Index Domain	66.1 score on a scale Standard Deviation 22.5	70.5 score on a scale Standard Deviation 24.9

SECONDARY outcome

Timeframe: 6 months

The SF36 Standardized Physical Component Scale has been scaled to have a mean of zero and standard deviation of 10 in a general US population. Higher scores indicate better HRQoL.

Outcome measures

Measure	EN Only n=73 Participants Enteral nutrition no intervention	Enteral Nutrition + Parenteral Nutrition n=52 Participants Enteral nutrition with the addition of parenteral supplementation (Olimel 5.7%E/N9E). Olimel (5.7%E / N9E): OLIMEL(Amino Acids, Dextrose, Lipids, with / without Electrolytes) is indicated for parenteral nutrition for adults when oral or enteral nutrition is impossible, insufficient or contraindicated.
SF-36 Standardized Physical Component Scale	35.8 score on a scale Standard Deviation 11.2	39.3 score on a scale Standard Deviation 10.2

SECONDARY outcome

Timeframe: 6 months

The SF36 Standardized mental Component Scale has been scaled to have a mean of zero and standard deviation of 10 in a general US population. Higher scores indicate better HRQoL.

Outcome measures

Measure	EN Only n=73 Participants Enteral nutrition no intervention	Enteral Nutrition + Parenteral Nutrition n=52 Participants Enteral nutrition with the addition of parenteral supplementation (Olimel 5.7%E/N9E). Olimel (5.7%E / N9E): OLIMEL(Amino Acids, Dextrose, Lipids, with / without Electrolytes) is indicated for parenteral nutrition for adults when oral or enteral nutrition is impossible, insufficient or contraindicated.
SF-36 Standardized Mental Component Scale	43.2 score on a scale Standard Deviation 14.8	49 score on a scale Standard Deviation 13.5

Adverse Events

Enteral Nutrition + Parenteral Nutrition

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Enteral Nutrition Only

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr.Daren Heyland

CERU Queen's University

Phone: 403-915-5573

Email: dkh2@queensu.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place