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

• Sponsor: Clinical Evaluation Research Unit at Kingston General Hospital (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01206166
• Collaborator: Baxter Healthcare Corporation (Industry)
• Enrollment: 125
• Locations: 12
• Arms: 2
• Duration (Months): 49
• Patients Per Site: 10.4
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

The specific aim of the proposed study is to conduct a pilot study involving 160 critically-ill lean and obese patients enrolled at 11 sites in Canada, the United States of

America, Belgium and France in order to:

Specific Aims

• Confirm that we can achieve a clinically significant difference in calorie and protein intake between the two intervention groups.

• Estimate recruitment rate i.e. number of eligible and enrolled patients per month per site.

• Evaluate the safety, tolerance, and logistics around providing supplemental PN in the study population in the context of a multicenter trial, e.g.

• To ensure adequate glycemic control in both groups.

• To ensure that the other metabolic consequences of the feeding strategies are minimized.

• To establish adequate compliance with study protocols and completion of case report forms

A secondary aim of this pilot study will be:

• To explore the effect of differential effects of calorie and protein delivery on muscle and mass function.

Condition or Disease	Intervention/Treatment	Phase
Critical Illness; Acute Respiratory Failure	Drug: Olimel (5.7%E / N9E)	Phase 3

Detailed Description

Background

Critically ill patients are often hypermetabolic and can rapidly become nutritionally compromised. Malnutrition is prevalent in these patients and has been associated with increased morbidity and mortality. Standard nutrition therapy, i.e. provision of calories, protein and other nutrients consists primarily of enteral nutrition (via a feeding tube into the gastrointestinal tract), parenteral nutrition (via an intravenous tube into the blood), or occasionally a combination of both.

However, the provision of nutrition is sub-optimal and the majority of critically-ill patients do not meet nutritional requirements. Recent studies report that average energy intakes of critically ill patients are only 49% to 70% of calculated requirements. Despite repeated, sustained efforts over the past few years, the investigators have not significantly improved the amount of calories delivered via the enteral route. This leads us to conclude that if the investigators are to be successful at increasing the provision of calories and protein to patients at-risk, the investigators will have to supplement the calories via the parenteral route.

Critically ill patients that are at extremes of weight are at a higher nutritional risk and have higher mortality rates. A recent International multicenter observational study of 2772 ICU patients from 165 ICUs showed a significant inverse linear relationship between the odds of mortality and total daily calories received. Increased amounts of calories was most important for the BMI < 20 group followed by the BMI 20 -< 25 group and BMI > 35 group with no benefit of increased calorie intake for patients in the BMI 25 -< 35 group. Feeding an additional 1000 kcals almost halved the odds of 60-day mortality in patients with a BMI < 25 or > 35. Similar results were observed for feeding an additional 30 grams of protein per day.

Thus, a prospective randomized trial is warranted to confirm our hypothesis that in patients with a BMI of < 25 and those with a BMI > 35 increasing the provision of more energy and protein can impact clinical outcomes. The results of this study will serve to answer some fundamental questions with regards to impact of amount of energy and protein delivered to nutritional at-risk ICU patients and will inform current practice.

Study Intervention:

Patients will be randomized to one of 2 interventions: enteral nutrition alone or enteral nutrition plus parenteral nutrition (supplemental PN group).

Study Design

• Study Type: Interventional
• Actual Enrollment: 125 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: A Randomized Trial of Supplemental Parenteral Nutrition in Under and Over Weight Critically Ill Patients: The TOP UP Trial (Pilot)
• Study Start Date: Jun 1, 2011
• Actual Primary Completion Date: Mar 1, 2015
• Actual Study Completion Date: Jul 1, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Calorie & Protein Intake 7 Days Post Randomization [7 days post randomization]

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

2. Calorie & Protein Intake in First 27 Days [first 27 days]

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

Secondary Outcome Measures

1. 6 Month Mortality [6 months]

   Kaplan-Meier estimate.

2. ICU Mortality [6 months]

3. Hospital Mortality [6 months]

4. Duration of ICU Stay [6 months]

5. Duration of Hospital Stay [6 months]

6. Duration of Mechanical Ventilation [6 months]

7. Development of ICU-acquired Infections [ICU discharge]

8. SF36-Physical Functioning Domain [3 months]

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

9. SF-36 Physical Functioning Domain [6 months]

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

10. Functional Status at Hospital Discharge [hospital discharge]

11. SF36 Role Physical Domain [3 months]

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

12. SF36 Pain Index Domain [3 months]

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

13. SF36 General Health Perceptions Domain [3 months]

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

14. SF36 Vitality Domain [3 months]

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

15. SF36 Social Functioning Domain [3 months]

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

16. SF36 Role-emotional Domain [3 months]

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

17. SF36 Mental Health Index Domain [3 months]

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

18. SF36 Standardized Physical Component Scale [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.

19. SF36 Standardized Mental Component Scale [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.

20. SF-36 Role-physical Domain [6 months]

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

21. SF-36 Pain Index Domain [6 months]

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

22. SF-36 General Health Perceptions Domain [6 months]

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

23. SF-36 Vitality Domain [6 months]

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

24. SF-36 Social Functioning Domain [6 months]

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

25. SF-36 Role-emotional Domain [6 months]

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

26. SF-36 Mental Health Index Domain [6 months]

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

27. SF-36 Standardized Physical Component Scale [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.

28. SF-36 Standardized Mental Component Scale [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Critically ill adult patient (≥ 18 years) admitted to ICU

• Has acute respiratory failure (ARF) i.e. expected to remain mechanically ventilated for more than 48 hours

• Expected ICU dependency of 5 or more days

• On or expected to initiate enteral nutrition within 7 days of ICU admission

• BMI <25 or ≥ 35 based on pre-ICU actual or estimated dry weight

Exclusion Criteria:

• 72 hours from admission to ICU to time of consent

• Not expected to survive an additional 48 hrs from screening evaluation

• A lack of commitment to full aggressive care (anticipated withholding or withdrawing treatments in the first week but isolated DNR acceptable)

• Patients already receiving PN at screening

• Absence of All gastrointestinal risk factors, defined as:

1. High Apache II Score (>20)

2. On more than 1 vasopressor or increasing doses or vasopressors

3. Receiving continuous infusion of narcotics

4. High nasogastric/orogastric output (>500 mL over 24 hours)

5. Recent surgery involving esophagus, stomach, or small bowel OR peritoneal contamination with bowel contents

6. Pancreatitis

7. Multiple gastrointestinal investigations

8. Recent history of diarrhea/C. Difficile

9. Surgical patients with future surgeries planned

10. Ruptured or dissected abdominal aortic aneurysm

• Patients admitted with diabetic ketoacidosis or non-ketotic hyperosmolar coma

• Pregnant or lactating patients

• Patients with clinical fulminant hepatic failure

• Patients with Cirrhosis Child's Class C Liver Disease (except those on a transplant list or transplantable)

• Dedicated port of central line not available

• Known allergy to study nutrients (soy, eggs or olive products)

• Enrolment in another industry sponsored ICU intervention study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Colorado DHSC	Boulder	Colorado	United States	80045
2	Washington University School of Medicine in St. Louis	Saint Louis	Missouri	United States	63110-1093
3	Mercy Hospital St. Louis	Saint Louis	Missouri	United States	63141
4	Cleveland Clinic Lerner College of Medicine	Cleveland	Ohio	United States	44195
5	The Ohio State Univsersity Medical Center	Columbus	Ohio	United States	43221
6	Oregon Health & Science University	Portland	Oregon	United States	97239-3098
7	University of Texas Health Science Center	Houston	Texas	United States	77030
8	Erasme University Hospital	Brussels		Belgium	B - 1070
9	Royal Alexandra Hospital	Edmonton	Alberta	Canada	T5H 3V9
10	University of Alberta	Edmonton	Alberta	Canada	T5H 3V9
11	Grey Nuns Hospital	Edmonton	Alberta	Canada	T6L 5X8
12	Nouvel Hôpital Civil	Strasbourg		France	F - 67091

Sponsors and Collaborators

• Clinical Evaluation Research Unit at Kingston General Hospital
• Baxter Healthcare Corporation

Investigators

• Study Chair: Daren K. Heyland, MD, Clinical Evaluation Research Unit, Kingston General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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. Erratum in: Intensive Care Med. 2009 Oct;35(10):1821.
• Dhaliwal R, Jurewitsch B, Harrietha D, Heyland DK. Combination enteral and parenteral nutrition in critically ill patients: harmful or beneficial? A systematic review of the evidence. Intensive Care Med. 2004 Aug;30(8):1666-71. Epub 2004 Jun 8. Review.
• Hise ME, Halterman K, Gajewski BJ, Parkhurst M, Moncure M, Brown JC. Feeding practices of severely ill intensive care unit patients: an evaluation of energy sources and clinical outcomes. J Am Diet Assoc. 2007 Mar;107(3):458-65.
• Krishnan JA, Parce PB, Martinez A, Diette GB, Brower RG. Caloric intake in medical ICU patients: consistency of care with guidelines and relationship to clinical outcomes. Chest. 2003 Jul;124(1):297-305.
• Villet S, Chiolero RL, Bollmann MD, Revelly JP, Cayeux R N MC, Delarue J, Berger MM. Negative impact of hypocaloric feeding and energy balance on clinical outcome in ICU patients. Clin Nutr. 2005 Aug;24(4):502-9.

• Responsible Party: Daren K. Heyland, Director, Clinical Evaluation Research Unit at Kingston General Hospital
• ClinicalTrials.gov Identifier: NCT01206166
• Other Study ID Numbers: TOP-UP
• First Posted: Sep 21, 2010
• Last Update Posted: Mar 16, 2021
• Last Verified: Feb 1, 2021

• Keywords provided by Daren K. Heyland, Director, Clinical Evaluation Research Unit at Kingston General Hospital: Randomized trial; Parental nutrition; Enteral nutrition; Intensive care unit; BMI < 25 or ≥ 35
• Additional relevant MeSH terms: Respiratory Insufficiency; Critical Illness; Overweight

Study Results

Participant Flow

Arm/Group Title	Enteral Nutrition + Parenteral Nutrition	Enteral Nutrition Only
Arm/Group Description	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 - no intervention
Period Title: Overall Study
STARTED	73	52
COMPLETED	71	49
NOT COMPLETED	2	3

Baseline Characteristics

Arm/Group Title	Enteral Nutrition + Parenteral Nutrition	Enteral Nutrition Only	Total
Arm/Group Description	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 - no intervention	Total of all reporting groups
Overall Participants	73	52	125
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	55.1 (16.2)	55.8 (19.8)	55.45 (18)
Sex: Female, Male (Count of Participants)
Female	34 46.6%	31 59.6%	65 52%
Male	39 53.4%	21 40.4%	60 48%
Race/Ethnicity, Customized (Count of Participants)
White	65 89%	46 88.5%	111 88.8%
Black or African American	4 5.5%	2 3.8%	6 4.8%
Native Hawaiian or Pacific Islander	2 2.7%	0 0%	2 1.6%
Native	2 2.7%	0 0%	2 1.6%
unknown/unreported	0 0%	4 7.7%	4 3.2%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

ICU patients

Arm/Group Title	EN Only	Enteral Nutrition + Parenteral Nutrition
Arm/Group Description	Enteral nutrition no intervention	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.
Measure Participants	71	49
calories in first 7 days	69 (28)	95 (13)
protein in first 7 days	64 (26)	86 (16)

2. Secondary Outcome

Title	6 Month Mortality
Description	Kaplan-Meier estimate.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Enteral Nutrition Only	Enteral Nutrition + Parenteral Nutrition
Arm/Group Description	Enteral nutrition no intervention	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.
Measure Participants	73	52
Number [percentage of participants]	27.5 37.7%	29.5 56.7%

3. Secondary Outcome

Title	ICU Mortality
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Enteral Nutrition Only	Enteral Nutrition + Parenteral Nutrition
Arm/Group Description	Enteral nutrition only - no intervention	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.
Measure Participants	73	52
Count of Participants [Participants]	13 17.8%	7 13.5%

4. Secondary Outcome

Title	Hospital Mortality
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Enteral Nutrition Only	Enteral Nutrition + Parenteral Nutrition
Arm/Group Description	Enteral nutrition only - no intervention	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.
Measure Participants	73	52
Count of Participants [Participants]	17 23.3%	8 15.4%

5. Secondary Outcome

Title	Duration of ICU Stay
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Enteral Nutrition Only	Enteral Nutrition + Parenteral Nutrition
Arm/Group Description	Enteral nutrition only - no intervention	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.
Measure Participants	73	52
Median (Inter-Quartile Range) [days]	12.6	12.8

6. Secondary Outcome

Title	Duration of Hospital Stay
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Enteral Nutrition Only	Enteral Nutrition + Parenteral Nutrition
Arm/Group Description	Enteral nutrition only - no intervention	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.
Measure Participants	73	52
Median (Inter-Quartile Range) [days]	24	23.5

7. Secondary Outcome

Title	Duration of Mechanical Ventilation
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Enteral Nutrition Only	Enteral Nutrition + Parenteral Nutrition
Arm/Group Description	Enteral nutrition only - no intervention	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.
Measure Participants	73	52
Median (Inter-Quartile Range) [days]	8.3	6.5

8. Secondary Outcome

Title	Development of ICU-acquired Infections
Time Frame	ICU discharge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Enteral Nutrition Only	Enteral Nutrition + Parenteral Nutrition
Arm/Group Description	Enteral nutrition only - no intervention	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.
Measure Participants	73	52
Count of Participants [Participants]	23 31.5%	14 26.9%

9. Secondary Outcome

Title	SF36-Physical Functioning Domain
Description	The SF-36 physical function domain ranges from 0-100. Higher scores indicate better outcome.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Enteral Nutrition Only	Enteral Nutrition + Parenteral Nutrition
Arm/Group Description	Enteral Nutrition only-no intervention	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.
Measure Participants	73	52
Mean (Standard Deviation) [score on a scale]	39.4 (34.3)	34.8 (31.5)

10. Secondary Outcome

Title	SF-36 Physical Functioning Domain
Description	The SF-36 physical function domain ranges from 0-100. Higher scores indicate better outcome.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Enteral Nutrition Only	Enteral Nutrition + Parenteral Nutrition
Arm/Group Description	Enteral nutrition only - no intervention	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.
Measure Participants	73	52
Mean (Standard Deviation) [score on a scale]	39.3 (34)	50.8 (36.5)

11. Secondary Outcome

Title	Functional Status at Hospital Discharge
Time Frame	hospital discharge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Enteral Nutrition Only	Enteral Nutrition + Parenteral Nutrition
Arm/Group Description	Enteral nutrition only - no intervention	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.
Measure Participants	73	52
Pt died	17 23.3%	8 15.4%
Unable to do	12 16.4%	5 9.6%
Refused to do	3 4.1%	3 5.8%
Done	22 30.1%	17 32.7%
Missed	16 21.9%	12 23.1%
Unknown reason	1 1.4%	4 7.7%
use ICU	2 2.7%	3 5.8%
Pt died	17 23.3%	8 15.4%
Unable to do	31 42.5%	20 38.5%
Refused to do	3 4.1%	3 5.8%
Done	9 12.3%	9 17.3%
Missed	12 16.4%	9 17.3%
Unknown reason	1 1.4%	3 5.8%
use ICU	0 0%	0 0%

12. Primary Outcome

Title	Calorie & Protein Intake in First 27 Days
Description	Amount of calories & protein received as a percentage of prescribed.
Time Frame	first 27 days

Outcome Measure Data

Analysis Population Description

ICU patients

Arm/Group Title	EN Only	Enteral Nutrition + Parenteral Nutrition
Arm/Group Description	Enteral nutrition no intervention	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.
Measure Participants	71	49
calories in first 27 days	72 (25)	90 (16)
protein in first 27 days	68 (25)	82 (19)

13. Secondary Outcome

Title	SF36 Role Physical Domain
Description	The SF-36 role physical function domain ranges from 0-100. Higher scores indicate better outcome.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Enteral Nutrition Only	Enteral Nutrition + Parenteral Nutrition
Arm/Group Description	Enteral Nutrition only-no intervention	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.
Measure Participants	73	52
Mean (Standard Deviation) [score on a scale]	30.2 (31.8)	32.8 (32.6)

14. Secondary Outcome

Title	SF36 Pain Index Domain
Description	The SF-36 pain index domain ranges from 0-100. Higher scores indicate better outcome.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Enteral Nutrition Only	Enteral Nutrition + Parenteral Nutrition
Arm/Group Description	Enteral Nutrition only-no intervention	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.
Measure Participants	73	52
Mean (Standard Deviation) [score on a scale]	59.1 (28.8)	66.4 (27.3)

15. Secondary Outcome

Title	SF36 General Health Perceptions Domain
Description	The SF-36 general health perceptions domain ranges from 0-100. Higher scores indicate better outcome.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Enteral Nutrition Only	Enteral Nutrition + Parenteral Nutrition
Arm/Group Description	Enteral Nutrition only-no intervention	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.
Measure Participants	73	52
Mean (Standard Deviation) [score on a scale]	61.2 (18.3)	49.5 (24.3)

16. Secondary Outcome

Title	SF36 Vitality Domain
Description	The SF-36 vitality domain ranges from 0-100. Higher scores indicate better outcome.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Enteral Nutrition Only	Enteral Nutrition + Parenteral Nutrition
Arm/Group Description	Enteral Nutrition only-no intervention	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.
Measure Participants	73	52
Mean (Standard Deviation) [score on a scale]	52.8 (21.4)	51 (21.7)

17. Secondary Outcome

Title	SF36 Social Functioning Domain
Description	The SF-36 social functioning domain ranges from 0-100. Higher scores indicate better outcome.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Enteral Nutrition Only	Enteral Nutrition + Parenteral Nutrition
Arm/Group Description	Enteral Nutrition only-no intervention	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.
Measure Participants	73	52
Mean (Standard Deviation) [score on a scale]	60.4 (31.8)	56.5 (28.2)

18. Secondary Outcome

Title	SF36 Role-emotional Domain
Description	The SF-36 role-emotion domain ranges from 0-100. Higher scores indicate better outcome.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Enteral Nutrition Only	Enteral Nutrition + Parenteral Nutrition
Arm/Group Description	Enteral Nutrition only-no intervention	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.
Measure Participants	73	52
Mean (Standard Deviation) [score on a scale]	63.2 (34.6)	65.3 (34.4)

19. Secondary Outcome

Title	SF36 Mental Health Index Domain
Description	The SF-36 mental health index domain ranges from 0-100. Higher scores indicate better outcome.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Enteral Nutrition Only	Enteral Nutrition + Parenteral Nutrition
Arm/Group Description	Enteral Nutrition only-no intervention	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.
Measure Participants	73	52
Mean (Standard Deviation) [score on a scale]	72.9 (18.7)	76.1 (18.5)

20. Secondary Outcome

Title	SF36 Standardized Physical Component Scale
Description	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.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Enteral Nutrition Only	Enteral Nutrition + Parenteral Nutrition
Arm/Group Description	Enteral Nutrition only-no intervention	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.
Measure Participants	73	52
Mean (Standard Deviation) [score on a scale]	35.3 (10.8)	33.3 (10.1)

21. Secondary Outcome

Title	SF36 Standardized Mental Component Scale
Description	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.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Enteral Nutrition Only	Enteral Nutrition + Parenteral Nutrition
Arm/Group Description	Enteral Nutrition only-no intervention	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.
Measure Participants	73	52
Mean (Standard Deviation) [score on a scale]	50 (10.5)	51.5 (10)

22. Secondary Outcome

Title	SF-36 Role-physical Domain
Description	The SF-36 mental health index domain ranges from 0-100. Higher scores indicate better outcome.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Enteral Nutrition Only	Enteral Nutrition + Parenteral Nutrition
Arm/Group Description	Enteral nutrition only - no intervention	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.
Measure Participants	73	52
Mean (Standard Deviation) [score on a scale]	40.2 (33.1)	47.5 (33.4)

23. Secondary Outcome

Title	SF-36 Pain Index Domain
Description	The SF-36 mental health index domain ranges from 0-100. Higher scores indicate better outcome.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Enteral Nutrition Only	Enteral Nutrition + Parenteral Nutrition
Arm/Group Description	Enteral nutrition only - no intervention	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.
Measure Participants	73	52
Mean (Standard Deviation) [score on a scale]	52.5 (31)	68.6 (28.2)

24. Secondary Outcome

Title	SF-36 General Health Perceptions Domain
Description	The SF-36 general health perceptions domain ranges from 0-100. Higher scores indicate better outcome.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Enteral Nutrition Only	Enteral Nutrition + Parenteral Nutrition
Arm/Group Description	Enteral nutrition only - no intervention	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.
Measure Participants	73	52
Mean (Standard Deviation) [score on a scale]	50.9 (20.6)	56.8 (26.2)

25. Secondary Outcome

Title	SF-36 Vitality Domain
Description	The SF-36 vitality domain ranges from 0-100. Higher scores indicate better outcome.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Enteral Nutrition Only	Enteral Nutrition + Parenteral Nutrition
Arm/Group Description	Enteral nutrition only - no intervention	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.
Measure Participants	73	52
Mean (Standard Deviation) [score on a scale]	47.8 (21.2)	59.1 (21.7)

26. Secondary Outcome

Title	SF-36 Social Functioning Domain
Description	The SF-36 social functioning domain ranges from 0-100. Higher scores indicate better outcome.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Enteral Nutrition Only	Enteral Nutrition + Parenteral Nutrition
Arm/Group Description	Enteral nutrition only - no intervention	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.
Measure Participants	73	52
Mean (Standard Deviation) [score on a scale]	50.4 (32.2)	68.8 (32.6)

27. Secondary Outcome

Title	SF-36 Role-emotional Domain
Description	The SF-36 role-emotional domain ranges from 0-100. Higher scores indicate better outcome.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Enteral Nutrition Only	Enteral Nutrition + Parenteral Nutrition
Arm/Group Description	Enteral nutrition only - no intervention	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.
Measure Participants	73	52
Mean (Standard Deviation) [score on a scale]	52.2 (41)	72.1 (30.3)

28. Secondary Outcome

Title	SF-36 Mental Health Index Domain
Description	The SF-36 mental health index domain ranges from 0-100. Higher scores indicate better outcome.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Enteral Nutrition Only	Enteral Nutrition + Parenteral Nutrition
Arm/Group Description	Enteral nutrition only - no intervention	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.
Measure Participants	73	52
Mean (Standard Deviation) [score on a scale]	66.1 (22.5)	70.5 (24.9)

29. Secondary Outcome

Title	SF-36 Standardized Physical Component Scale
Description	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.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Enteral Nutrition Only	Enteral Nutrition + Parenteral Nutrition
Arm/Group Description	Enteral nutrition only - no intervention	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.
Measure Participants	73	52
Mean (Standard Deviation) [score on a scale]	35.8 (11.2)	39.3 (10.2)

30. Secondary Outcome

Title	SF-36 Standardized Mental Component Scale
Description	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.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Enteral Nutrition Only	Enteral Nutrition + Parenteral Nutrition
Arm/Group Description	Enteral nutrition only - no intervention	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.
Measure Participants	73	52
Mean (Standard Deviation) [score on a scale]	43.2 (14.8)	49 (13.5)

Adverse Events

Time Frame	28 days
Adverse Event Reporting Description	Given the acuity of illness of critically ill patients, adverse events (defined as any untoward medical occurrences in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment) will not be collected.
Arm/Group Title	Enteral Nutrition + Parenteral Nutrition		Enteral Nutrition Only
Arm/Group Description	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 - no intervention
All Cause Mortality
	Enteral Nutrition + Parenteral Nutrition		Enteral Nutrition Only
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Serious Adverse Events
	Enteral Nutrition + Parenteral Nutrition		Enteral Nutrition Only
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Enteral Nutrition + Parenteral Nutrition		Enteral Nutrition Only
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

due to slower than anticipated enrollment and the upcoming end of the funding from the National Institutes of Health the study was prematurely terminated

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.