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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04931940
Registration number
NCT04931940
Ethics application status
Date submitted
31/05/2021
Date registered
18/06/2021
Date last updated
1/09/2021
Titles & IDs
Public title
The EFFORT Trial and EFFORT Outcomes Sub-study (EFFORT-Outcomes)
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Scientific title
The Effect of Higher Protein Dosing in Critically Ill Patients: A Multicenter Registry-based Randomized Trial - The EFFORT Trial and EFFORT Outcomes Sub-study
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Secondary ID [1]
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The EFFORT Outcomes sub-study
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Critical Illness
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Malnutrition
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Condition category
Condition code
Diet and Nutrition
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Other diet and nutrition disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Usual Care
Other interventions - Higher Protein/Amino Acid Group
Active Comparator: Usual Care - Patients will receive a usual protein/amino acid dose (=1.2 g/kg/d)
Active Comparator: Higher Protein/Amino Acid Group - Patients will receive a higher protein/amino acid dose (=2.2 g/kg/d).
Other interventions: Usual Care
Patients will receive the usual protein dosage at =1.2 g/kg/day for up to 28 days in the ICU
Other interventions: Higher Protein/Amino Acid Group
Patients will receive high protein dosage at =2.2 g/kg/day for up to 28 days in the ICU
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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6-minute walk test (6MWT)
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Assessment method [1]
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walking distance achieved during a 6-minute walk test (6MWT) measured at hospital discharge
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Timepoint [1]
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Within 72 hours before discharge from the hospital
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Secondary outcome [1]
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Quadriceps Muscle Mass
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Assessment method [1]
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Quadriceps muscle thickness and cross-sectional area measured by ultrasonography
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Timepoint [1]
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Day 1 and Day 10 of randomization, and within 72 hours before discharge from the hospital
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Secondary outcome [2]
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Functional Status Score for ICU (FSS-ICU)
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Assessment method [2]
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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
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Timepoint [2]
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Day 1 of randomization (surrogate interview), within 72 hours before discharge from the ICU and hospital (by trained physiotherapist)
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Secondary outcome [3]
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Handgrip strength
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Assessment method [3]
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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.
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Timepoint [3]
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Within 72 hours before discharge from the ICU and hospital
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Secondary outcome [4]
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Short Physical Performance Battery (SPPB)
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Assessment method [4]
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which measures balance, walking speed, and rising from a chair
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Timepoint [4]
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Within 72 hours before discharge from the ICU and hospital
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Secondary outcome [5]
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Quadriceps force
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Assessment method [5]
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via hand-held dynamometry (HHD) for of both lower extremities. Each will be scored by, averaging the results of 3 trials.
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Timepoint [5]
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Within 72 hours before discharge from the hospital
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Secondary outcome [6]
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Overall strength
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Assessment method [6]
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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)
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Timepoint [6]
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Within 72 hours before discharge from the hospital
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Eligibility
Key inclusion criteria
1. - =18 years old
2. - Nutritionally 'high-risk' (meeting one of the below criteria)
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
3. - Requiring mechanical ventilation with actual or expected total duration of
mechanical ventilation >48 hours
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. >96 continuous hours of mechanical ventilation before screening
2. Expected death or withdrawal of life-sustaining treatments within 7 days from
screening
3. Pregnant
4. The responsible clinician feels that the patient either needs low or high protein
5. Patient requires parenteral nutrition only and site does not have products to reach
the high protein dose group.
6. Not ambulating independently prior to illness that leads to ICU admission (use of gait
aid permitted)
7. Lower extremity injury or impairments that prevents them from walking prior to
hospital discharge (e.g. amputation, knee/hip injury)
8. Pre-existing cognitive impairment or language barrier that prohibits outcomes
assessment
9. Pre-existing primary severe systemic neuromuscular disease resulting in severe
weakness pre-ICU (e.g., Guillain Barre) 10 Intracranial or spinal process affecting
motor function
11. Patients in hospital >5 days prior to ICU admission 12. Not expected to stay =4 days
after enrollment
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Unknown status
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/12/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2022
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Actual
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Sample size
Target
142
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Gold Coast Hospital and Health Service - Gold Coast
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Recruitment postcode(s) [1]
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- Gold Coast
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Recruitment outside Australia
Country [1]
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Malaysia
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State/province [1]
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Kuala Lumpur
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Funding & Sponsors
Primary sponsor type
Other
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Name
Clinical Evaluation Research Unit at Kingston General Hospital
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
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
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04931940
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Daren K Heyland, DM
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Address
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Clinical Evaluation Research Unit
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Daren K Heyland, DM
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Address
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Country
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Phone
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1 403 915-5573
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04931940
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