EFFORTcomboThe Effect of Higher Protein Dosing in Critically Ill Patients: A Multicenter Randomized Trial
OLIMEL 7,6%E / PeriOLIMEL 2,5%E
Frailty+13
+ Atrophy
+ Muscular Atrophy
Prevention Study
Summary
Study start date: June 1, 2020
Actual date on which the first participant was enrolled.Positive, neutral, or negative, the results of the EFFORTcombo study will inform the clinical practice in ICU settings around the world. If positive, because of the pragmatic, multicentre nature of this trial, results will be broadly applicable to all critically ill patients worldwide. If the results are negative, it will be ensured that patients no longer receive high-dose protein/amino acid admixtures or possibly, combined EN/PN. As it relates to critical care nutrition practice in general, there is a long history of practice-changing initiatives. A process of synthesizing (in the form of evidence-based clinical practice guidelines) and disseminating best practice ideas (in the form of web-based repository of tools and information \[see www.criticalcarenutrition.com\]) was established. Over the past several years, this program of research with leaders of the American Society of Parenteral and Enteral Nutrition (ASPEN) and this specific protocol at the annual Clinical Nutrition Week with society leaders, researchers, and the clinical nutrition community at large has been discussed. Partnership with ASPEN will further facilitate both, recruitment initiatives and, importantly, the knowledge translation initiatives. These efforts will increase the likelihood of the uptake of EFFORT results across the world. This study has both the potential to answer a high-priority clinical question and also transform the new approach in clinical nutrition research. It further represents a unique collaboration between ASPEN, its global partners, and the Clinical Evaluation Research Unit, a methodological support center based in Kingston, Ontario, Canada and managed by Dr. Daren Heyland. If successful, this type of collaboration sets an important precedent for how this community may approach additional research questions related to clinical nutrition. Nested within this larger volunteer-driven registry trial, the aim is to complete a significant sub-study that will establish the role of combined EN/PN in these nutritionally high-risk patients. This protocol pertains to the specifics of this sub-study of combined EN/PN. At the end of the trial, the data from this sub-study will be merged into the results of the overall parent EFFORT Trial (where data points are similar).
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: 1. ≥18 years old; 2. Expected to remain mechanically ventilated for an additional 48 hours from screening; 3. And have one or more of the following risk factors that make them at high nutritional risk: 1. Low (≤25) or High BMI (≥35) 2. Moderate to severe malnutrition (as defined by local assessments). We will document the means by which sites are making this determination and capture the elements of the assessment (history of weight loss, history of reduced oral intake, etc.). 3. Frailty (Clinical Frailty Scale 5 or more from proxy) 4. Sarcopenia (SARC-F score of 4 or more from proxy) 5. From point of screening, projected duration of mechanical ventilation \>4 days Exclusion Criteria: 1. \>96 continuous hours of mechanical ventilation before enrollment 2. Expected death or withdrawal of life-sustaining treatments within 7 days from screening 3. Pregnancy 4. The responsible clinician feels that the patient either needs low or high protein 5. Absolute contraindication to EN 6. Severe metabolic disorders including electrolyte disorders, uncontrolled hyperglycemia, hyperlipidemia, hypophosphatemia. 7. Severe chronic liver disease (MELD-score \>20) or acute fulminant hepatitis. 8. Metabolic disorders involving impaired nitrogen utilization 9. Not ambulating independently prior to illness that lead to ICU admission (use of gait aid permitted) 10. Lower extremity injury or impairments that prevents them walking prior to hospital discharge (e.g. amputation, knee/hip injury) 11. Pre-existing cognitive impairment or language barrier that prohibits outcomes assessment 12. Pre-existing primary severe systemic neuromuscular disease resulting in severe weakness pre-ICU (e.g., Guillain Barre) 13. Intracranial or spinal process affecting motor function 14. Patients in hospital \>5 days prior to ICU admission
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location