An interventional study of Usual Care and Higher Protein/Amino Acid Group in Critical Illness and Malnutrition, sponsored by Clinical Evaluation Research Unit at Kingston General Hospital. Status unknown at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-01.
Sponsored by Clinical Evaluation Research Unit at Kingston General Hospital · Not applicable, Interventional, and Prevention
The investigators will evaluate the effects of higher protein/amino acid dosing (≥2.2 g/kg/d) vs usual care of protein/amino acid dosing (≤1.2 g/kg/d) over muscle mass in nutritionally high risk ill patients
The EFFORT Outcomes is a sub-study of the parent EFFORT trial; a multi-center, pragmatic, volunteer-driven, registry-based, randomized, clinical trial of 4000 nutritionally high-risk critically ill patients in the intensive care unit. Patients will be randomized to 1 of 2 treatment groups: a usual care prescription (≤1.2 g/kg/d) or a higher prescription (≥2.2 g/kg/d) of protein. Other than the protein amount the patient is randomized to, the remainder of care provided to randomized patient will be at the discretion of ICU providers. In both groups, targets will be achieved through any combination of enteral nutrition (high protein content in high group if available), protein supplements, and parenteral nutrition or amino acids only (as clinically available). The only difference between the 2 groups is the protein targets that are set. Similar efforts should be used in both groups to achieve at least 80% of these targets. The remainder of care provided to eligible patients will be at the discretion of ICU providers.
In patients included in the OUTCOMES sub-study, we will test the patient's functional recovery and long-term quality of life. Patients will undergo the US measures at baseline (within 24 hours of randomization, 10 days post randomization (if still in hospital) and just prior to hospital discharge. In the event that hospital discharge is prior to day 10, the day 10 measure will not be done. To ensure standardization and quality in the measures, we have created high quality training materials and will have US films sent centrally to abstract all measurements. In the first 10 patients enrolled in the US sub-study, participating sites will conduct a run-in phase where their submitted data will be evaluated for quality and reliability (both intra and inter-rater reliability) to ensure subsequent measures are of high quality. Nutritional and clinical data for these patients will be included in the parent EFFORT trial but the US measures may be omitted if quality is poor.
The investigator has posed the following research question:
Primary Outcome of the OUTCOMES Sub-study
The primary outcome will be the walking distance achieved during a 6-minute walk test (6MWT) measured at hospital discharge. Implementation of the test will be based upon the 2014 ATS standards, with adaptation, as needed, for the in-patient setting and ICU survivor population. The 6MWT is a reliable, valid, responsive measure of physical function for survivors of acute respiratory failure.
Secondary measures for this OUTCOMES sub-study will include;
Lastly, outcomes after hospital discharge will be assessed via 6-month phone-based follow-up. Health-related quality of life (QOL) will be measured using SF-36 version 2 (SF-36 v2) and EQ-5D-5L. The SF-36 is valid and reliable across a variety of patient groups, including ICU survivors. The EQ-5D-5L is included, in addition to SF-36 v2, because it is suitable for patients with inattention and fatigue, recommended for use in ICU survivors. Physical functional status will be measured using Katz activities of daily living (ADL) and Lawton's Instrumental ADL (IADL). In order to improve retention, a call will be made to participants at 3 months to update contact information and act as a reminder of upcoming follow-up assessments to be completed at the 6-month time point.
Overall Hypothesis: Compared to receiving a lower dose of protein/amino acids, the administration of a higher dose of protein/amino acids (a consequence of having a higher prescription) to nutritionally high-risk critically ill patients will be associated with greater muscle mass, improved survival and a quicker rate of recovery.
1,587 studies on the registry are indexed under Malnutrition; 237 are open to participants now.
This study's planned enrollment of 142 is above the median of 90 across 1,134 interventional studies indexed under Malnutrition.
Browse Malnutrition studies →Clinical Evaluation Research Unit at Kingston General Hospital is the lead sponsor of 11 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Nutritionally 'high-risk' (meeting one of the below criteria)
Exclusion Criteria:
Patients will receive a usual protein/amino acid dose (≤1.2 g/kg/d)
Dietary Supplement: Usual Care
Patients will receive a higher protein/amino acid dose (≥2.2 g/kg/d).
Dietary Supplement: Higher Protein/Amino Acid Group
Patients will receive the usual protein dosage at ≤1.2 g/kg/day for up to 28 days in the ICU
Patients will receive high protein dosage at ≥2.2 g/kg/day for up to 28 days in the ICU
6-minute walk test (6MWT)
walking distance achieved during a 6-minute walk test (6MWT) measured at hospital discharge
Time frame: Within 72 hours before discharge from the hospital
Quadriceps Muscle Mass
Quadriceps muscle thickness and cross-sectional area measured by ultrasonography
Time frame: Day 1 and Day 10 of randomization, and within 72 hours before discharge from the hospital
Functional Status Score for ICU (FSS-ICU)
which is a 5-item, 35-point assessment of bed mobility, transfers, and ambulation. designed for ICU patients, and was designed and validated specifically in ICU patients evaluated 8-point Functional Independence Measure (FIM) response scale used throughout rehabilitation assessments, and is responsive to change during recovery for ICU patients
Time frame: Day 1 of randomization (surrogate interview), within 72 hours before discharge from the ICU and hospital (by trained physiotherapist)
Handgrip strength
measured via isometric hand grip strength via a hydraulic hand dynamometer performed bilaterally as per American Society of Hand Therapist guidelines and evaluated using normal values.
Time frame: Within 72 hours before discharge from the ICU and hospital
Short Physical Performance Battery (SPPB)
which measures balance, walking speed, and rising from a chair
Time frame: Within 72 hours before discharge from the ICU and hospital
Quadriceps force
via hand-held dynamometry (HHD) for of both lower extremities. Each will be scored by, averaging the results of 3 trials.
Time frame: Within 72 hours before discharge from the hospital
Overall strength
using Medical Research Council (MRC) sum-score evaluated via standardized "manual muscle testing" with each of 12 muscle groups assessed using a 6-point MRC scale and summed to a total score (range: 0-60)
Time frame: Within 72 hours before discharge from the hospital
Health related quality of life by Short-Form 36 version 2 (SF-36 v2)
The SF-36 physical function domain ranges from 0-100. Higher scores indicate better outcome.
Time frame: 6 months post-randomization
Health-related Quality of life by Euro Quality of Life 5 Dimension 5 level (EQ-5D-5L)
The overall health scale where the rater selects a number between 1-100 to describe the condition of their health, 100 being the best imaginable.
Time frame: 6 months post-randomization
Plan to share: Undecided
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This study is status unknown, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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Clinical Evaluation Research Unit at Kingston General Hospital