Trial of Supplemental Parenteral Nutrition in Under and O... | NCT01206166

Name	Class
Baxter Healthcare Corporation	INDUSTRY

Label	Type	Description	Intervention Names
Enteral Nutrition + Parenteral Nutrition	Experimental	Enteral nutrition with the addition of parenteral supplementation (Olimel 5.7%E/N9E).	Drug: Olimel (5.7%E / N9E)
Enteral Nutrition Only	No Intervention	Enteral nutrition only - no intervention

Name	Type	Description	Arm Group Labels	Other Names
Olimel (5.7%E / N9E)	Drug	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.

Measure	Description	Time Frame
Calorie & Protein Intake 7 Days Post Randomization	Amount of calories & protein received as a percentage of prescribed.	7 days post randomization
Calorie & Protein Intake in First 27 Days	Amount of calories & protein received as a percentage of prescribed.	first 27 days

Measure	Description	Time Frame
6 Month Mortality	Kaplan-Meier estimate.	6 months
ICU Mortality		6 months
Hospital Mortality

Name	Affiliation	Role
Daren K. Heyland, MD	Clinical Evaluation Research Unit, Kingston General Hospital	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
University of Colorado DHSC		Boulder	Colorado	80045	United States
Washington University School of Medicine in St. Louis

PubMed Identifier	Type	Citation	Retractions
19572118	Background	Alberda C, Gramlich L, Jones N, Jeejeebhoy K, Day AG, Dhaliwal R, Heyland DK. The relationship between nutritional intake and clinical outcomes in critically ill patients: results of an international multicenter observational study. Intensive Care Med. 2009 Oct;35(10):1728-37. doi: 10.1007/s00134-009-1567-4. Epub 2009 Jul 2.
15899538

ID	Title	Description
FG000	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.

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

Calorie & Protein Intake 7 Days Post Randomization

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

ICU patients

Posted

Mean

Standard Deviation

percentage of prescribed

7 days post randomization

ID	Title	Description
OG000	EN Only	Enteral nutrition no intervention
OG001	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.

Units	Counts
Participants	OG00071 OG00149

Title

Denominators

Categories

calories in first 7 days

Title	Measurements
	OG00069± 28 OG00195± 13

protein in first 7 days

Title	Measurements
	OG000

Secondary

6 Month Mortality

Kaplan-Meier estimate.

Posted

Number

percentage of participants

6 months

ID	Title	Description
OG000	Enteral Nutrition Only	Enteral nutrition no intervention
OG001	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.

Units	Counts
Participants	OG000

Secondary

ICU Mortality

Posted

Count of Participants

Participants

6 months

ID	Title	Description
OG000	Enteral Nutrition Only	Enteral nutrition only - no intervention
OG001	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.

Units	Counts
Participants	OG000

Secondary

Hospital Mortality

Posted

Count of Participants

Participants

6 months

ID	Title	Description
OG000	Enteral Nutrition Only	Enteral nutrition only - no intervention
OG001	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.

Units	Counts
Participants	OG000

Secondary

Duration of ICU Stay

Posted

Median

Inter-Quartile Range

days

6 months

ID	Title	Description
OG000	Enteral Nutrition Only	Enteral nutrition only - no intervention
OG001	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.

Units	Counts
Participants	OG000

Secondary

Duration of Hospital Stay

Posted

Median

Inter-Quartile Range

days

6 months

ID	Title	Description
OG000	Enteral Nutrition Only	Enteral nutrition only - no intervention
OG001	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.

Units	Counts
Participants	OG000

Secondary

Duration of Mechanical Ventilation

Posted

Median

Inter-Quartile Range

days

6 months

ID	Title	Description
OG000	Enteral Nutrition Only	Enteral nutrition only - no intervention
OG001	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.

Units	Counts
Participants	OG000

Secondary

Development of ICU-acquired Infections

Posted

Count of Participants

Participants

ICU discharge

ID	Title	Description
OG000	Enteral Nutrition Only	Enteral nutrition only - no intervention
OG001	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.

Units	Counts
Participants	OG000

Secondary

SF36-Physical Functioning Domain

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

Posted

Mean

Standard Deviation

score on a scale

3 months

ID	Title	Description
OG000	Enteral Nutrition Only	Enteral Nutrition only-no intervention
OG001	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.

Units	Counts
Participants	OG000

Secondary

SF-36 Physical Functioning Domain

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

Posted

Mean

Standard Deviation

score on a scale

6 months

ID	Title	Description
OG000	Enteral Nutrition Only	Enteral nutrition only - no intervention
OG001	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.

Units	Counts
Participants	OG000

Secondary

Functional Status at Hospital Discharge

Posted

Count of Participants

Participants

hospital discharge

ID	Title	Description
OG000	Enteral Nutrition Only	Enteral nutrition only - no intervention
OG001	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.

Units	Counts
Participants	OG000

Primary

Calorie & Protein Intake in First 27 Days

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

ICU patients

Posted

Mean

Standard Deviation

percentage of prescribed

first 27 days

ID	Title	Description
OG000	EN Only	Enteral nutrition no intervention
OG001	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.

Units	Counts
Participants	OG000

Secondary

SF36 Role Physical Domain

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

Posted

Mean

Standard Deviation

score on a scale

3 months

ID	Title	Description
OG000	Enteral Nutrition Only	Enteral Nutrition only-no intervention
OG001	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.

Units	Counts
Participants	OG000

Secondary

SF36 Pain Index Domain

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

Posted

Mean

Standard Deviation

score on a scale

3 months

ID	Title	Description
OG000	Enteral Nutrition Only	Enteral Nutrition only-no intervention
OG001	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.

Units	Counts
Participants	OG000

Secondary

SF36 General Health Perceptions Domain

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

Posted

Mean

Standard Deviation

score on a scale

3 months

ID	Title	Description
OG000	Enteral Nutrition Only	Enteral Nutrition only-no intervention
OG001	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.

Units	Counts
Participants	OG000

Secondary

SF36 Vitality Domain

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

Posted

Mean

Standard Deviation

score on a scale

3 months

ID	Title	Description
OG000	Enteral Nutrition Only	Enteral Nutrition only-no intervention
OG001	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.

Units	Counts
Participants	OG000

Secondary

SF36 Social Functioning Domain

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

Posted

Mean

Standard Deviation

score on a scale

3 months

ID	Title	Description
OG000	Enteral Nutrition Only	Enteral Nutrition only-no intervention
OG001	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.

Units	Counts
Participants	OG000

Secondary

SF36 Role-emotional Domain

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

Posted

Mean

Standard Deviation

score on a scale

3 months

ID	Title	Description
OG000	Enteral Nutrition Only	Enteral Nutrition only-no intervention
OG001	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.

Units	Counts
Participants	OG000

Secondary

SF36 Mental Health Index Domain

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

Posted

Mean

Standard Deviation

score on a scale

3 months

ID	Title	Description
OG000	Enteral Nutrition Only	Enteral Nutrition only-no intervention
OG001	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.

Units	Counts
Participants	OG000

Secondary

SF36 Standardized Physical Component Scale

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.

Posted

Mean

Standard Deviation

score on a scale

3 months

ID	Title	Description
OG000	Enteral Nutrition Only	Enteral Nutrition only-no intervention
OG001	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.

Units	Counts
Participants	OG000

Secondary

SF36 Standardized Mental Component Scale

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.

Posted

Mean

Standard Deviation

score on a scale

3 months

ID	Title	Description
OG000	Enteral Nutrition Only	Enteral Nutrition only-no intervention
OG001	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.

Units	Counts
Participants	OG000

Secondary

SF-36 Role-physical Domain

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

Posted

Mean

Standard Deviation

score on a scale

6 months

ID	Title	Description
OG000	Enteral Nutrition Only	Enteral nutrition only - no intervention
OG001	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.

Units	Counts
Participants	OG000

Secondary

SF-36 Pain Index Domain

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

Posted

Mean

Standard Deviation

score on a scale

6 months

ID	Title	Description
OG000	Enteral Nutrition Only	Enteral nutrition only - no intervention
OG001	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.

Units	Counts
Participants	OG000

Secondary

SF-36 General Health Perceptions Domain

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

Posted

Mean

Standard Deviation

score on a scale

6 months

ID	Title	Description
OG000	Enteral Nutrition Only	Enteral nutrition only - no intervention
OG001	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.

Units	Counts
Participants	OG000

Secondary

SF-36 Vitality Domain

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

Posted

Mean

Standard Deviation

score on a scale

6 months

ID	Title	Description
OG000	Enteral Nutrition Only	Enteral nutrition only - no intervention
OG001	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.

Units	Counts
Participants	OG000

Secondary

SF-36 Social Functioning Domain

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

Posted

Mean

Standard Deviation

score on a scale

6 months

ID	Title	Description
OG000	Enteral Nutrition Only	Enteral nutrition only - no intervention
OG001	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.

Units	Counts
Participants	OG000

Secondary

SF-36 Role-emotional Domain

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

Posted

Mean

Standard Deviation

score on a scale

6 months

ID	Title	Description
OG000	Enteral Nutrition Only	Enteral nutrition only - no intervention
OG001	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.

Units	Counts
Participants	OG000

Secondary

SF-36 Mental Health Index Domain

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

Posted

Mean

Standard Deviation

score on a scale

6 months

ID	Title	Description
OG000	Enteral Nutrition Only	Enteral nutrition only - no intervention
OG001	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.

Units	Counts
Participants	OG000

Secondary

SF-36 Standardized Physical Component Scale

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.

Posted

Mean

Standard Deviation

score on a scale

6 months

ID	Title	Description
OG000	Enteral Nutrition Only	Enteral nutrition only - no intervention
OG001	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.

Units	Counts
Participants	OG000

Secondary

SF-36 Standardized Mental Component Scale

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.

Posted

Mean

Standard Deviation

score on a scale

6 months

ID	Title	Description
OG000	Enteral Nutrition Only	Enteral nutrition only - no intervention
OG001	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.

Units	Counts
Participants	OG000

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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.	0	0	0	0	0	0
EG001	Enteral Nutrition Only	Enteral nutrition only - no intervention	0	0	0	0	0	0

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Title	Description
BG000	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.
BG001	Enteral Nutrition Only	Enteral nutrition only - no intervention
BG002	Total	Total of all reporting groups