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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
125
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.
University of Colorado DHSC
Boulder, Colorado, United States
Washington University School of Medicine in St. Louis
St Louis, Missouri, United States
Mercy Hospital St. Louis
St Louis, Missouri, United States
Cleveland Clinic Lerner College of Medicine
Cleveland, Ohio, United States
The Ohio State Univsersity Medical Center
Columbus, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
University of Texas Health Science Center
Houston, Texas, United States
Erasme University Hospital
Brussels, Belgium
Royal Alexandra Hospital
Edmonton, Alberta, Canada
University of Alberta
Edmonton, Alberta, Canada
...and 2 more locations
Calorie & Protein Intake 7 Days Post Randomization
Amount of calories \& protein received as a percentage of prescribed.
Time frame: 7 days post randomization
Calorie & Protein Intake in First 27 Days
Amount of calories \& protein received as a percentage of prescribed.
Time frame: first 27 days
6 Month Mortality
Kaplan-Meier estimate.
Time frame: 6 months
ICU Mortality
Time frame: 6 months
Hospital Mortality
Time frame: 6 months
Duration of ICU Stay
Time frame: 6 months
Duration of Hospital Stay
Time frame: 6 months
Duration of Mechanical Ventilation
Time frame: 6 months
Development of ICU-acquired Infections
Time frame: ICU discharge
SF36-Physical Functioning Domain
The SF-36 physical function domain ranges from 0-100. Higher scores indicate better outcome.
Time frame: 3 months
SF-36 Physical Functioning Domain
The SF-36 physical function domain ranges from 0-100. Higher scores indicate better outcome.
Time frame: 6 months
Functional Status at Hospital Discharge
Time frame: hospital discharge
SF36 Role Physical Domain
The SF-36 role physical function domain ranges from 0-100. Higher scores indicate better outcome.
Time frame: 3 months
SF36 Pain Index Domain
The SF-36 pain index domain ranges from 0-100. Higher scores indicate better outcome.
Time frame: 3 months
SF36 General Health Perceptions Domain
The SF-36 general health perceptions domain ranges from 0-100. Higher scores indicate better outcome.
Time frame: 3 months
SF36 Vitality Domain
The SF-36 vitality domain ranges from 0-100. Higher scores indicate better outcome.
Time frame: 3 months
SF36 Social Functioning Domain
The SF-36 social functioning domain ranges from 0-100. Higher scores indicate better outcome.
Time frame: 3 months
SF36 Role-emotional Domain
The SF-36 role-emotion domain ranges from 0-100. Higher scores indicate better outcome.
Time frame: 3 months
SF36 Mental Health Index Domain
The SF-36 mental health index domain ranges from 0-100. Higher scores indicate better outcome.
Time frame: 3 months
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.
Time frame: 3 months
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.
Time frame: 3 months
SF-36 Role-physical Domain
The SF-36 mental health index domain ranges from 0-100. Higher scores indicate better outcome.
Time frame: 6 months
SF-36 Pain Index Domain
The SF-36 mental health index domain ranges from 0-100. Higher scores indicate better outcome.
Time frame: 6 months
SF-36 General Health Perceptions Domain
The SF-36 general health perceptions domain ranges from 0-100. Higher scores indicate better outcome.
Time frame: 6 months
SF-36 Vitality Domain
The SF-36 vitality domain ranges from 0-100. Higher scores indicate better outcome.
Time frame: 6 months
SF-36 Social Functioning Domain
The SF-36 social functioning domain ranges from 0-100. Higher scores indicate better outcome.
Time frame: 6 months
SF-36 Role-emotional Domain
The SF-36 role-emotional domain ranges from 0-100. Higher scores indicate better outcome.
Time frame: 6 months
SF-36 Mental Health Index Domain
The SF-36 mental health index domain ranges from 0-100. Higher scores indicate better outcome.
Time frame: 6 months
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.
Time frame: 6 months
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.
Time frame: 6 months
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