EFFORT Trial
Research type
Research Study
Full title
The Effect of Higher Protein Dosing in Critically Ill Patients: A Multicenter Registry-based Randomized Trial - The EFFORT Trial
IRAS ID
230338
Contact name
Daren Heyland
Contact email
Sponsor organisation
Queen’s University at Kingston
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
The EFFORT trial is aiming to answer the question 'What is the optimal dose of protein or the effect of high amounts of protein provided to critically ill patients?' Prior studies from the lead research group in Canada have demonstrated that increased provision of protein and calories to critically ill patients is associated with reduced infectious complications, more ventilator-free days, improved long-term physical recovery, and lower mortality. However, the optimal amount remains unknown even though experts recommend, from weak evidence, that critically ill patients should receive 1.2-2.5 g/kg/day of protein.
This study will be a registry based, randomised controlled trial which will aim to determine the optimal dose of protein (less than 1.2g/kg/day or more than 2.2g/kg/day). These numbers were chosen based on International Nutrition Survey (INS; a registry with data collection done by volunteers around the world) data that has shown that even though patients were prescribed an average of 1.3 g/kg/day (interquartile range, 1.0-1.5 grams/kg/day, overall range, 0.5-3.8 grams/kg/day) they actually received only 55% of their prescribed amounts. However, there was significant variability in the protein prescription at each individual sit with the median prescription being 1.2 gram/kg/day and the range 0.86 to 2.6g/kg/day.
The study will be an international, randomised controlled trial and participants will receive feeding using the usual methods available on the ICU (tube feeding or intravenous feeding). Data will then be collected from the participant’s medical notes to determine the outcome.
We hope that the results of this study will be used to determine the optimal protein dose to improve the outcome of critically ill patients that will lead to a change in practice.REC name
London - Queen Square Research Ethics Committee
REC reference
19/LO/0236
Date of REC Opinion
8 Mar 2019
REC opinion
Favourable Opinion