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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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)
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
Secondary ID [1] 0 0
The EFFORT Outcomes sub-study
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critical Illness 0 0
Malnutrition 0 0
Condition category
Condition code
Diet and Nutrition 0 0 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Usual Care
Treatment: Other - 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).


Treatment: Other: Usual Care
Patients will receive the usual protein dosage at =1.2 g/kg/day for up to 28 days in the ICU

Treatment: Other: 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
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
6-minute walk test (6MWT)
Timepoint [1] 0 0
Within 72 hours before discharge from the hospital
Secondary outcome [1] 0 0
Quadriceps Muscle Mass
Timepoint [1] 0 0
Day 1 and Day 10 of randomization, and within 72 hours before discharge from the hospital
Secondary outcome [2] 0 0
Functional Status Score for ICU (FSS-ICU)
Timepoint [2] 0 0
Day 1 of randomization (surrogate interview), within 72 hours before discharge from the ICU and hospital (by trained physiotherapist)
Secondary outcome [3] 0 0
Handgrip strength
Timepoint [3] 0 0
Within 72 hours before discharge from the ICU and hospital
Secondary outcome [4] 0 0
Short Physical Performance Battery (SPPB)
Timepoint [4] 0 0
Within 72 hours before discharge from the ICU and hospital
Secondary outcome [5] 0 0
Quadriceps force
Timepoint [5] 0 0
Within 72 hours before discharge from the hospital
Secondary outcome [6] 0 0
Overall strength
Timepoint [6] 0 0
Within 72 hours before discharge from the hospital

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2022
Actual
Sample size
Target
142
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Gold Coast Hospital and Health Service - Gold Coast
Recruitment postcode(s) [1] 0 0
- Gold Coast
Recruitment outside Australia
Country [1] 0 0
Malaysia
State/province [1] 0 0
Kuala Lumpur

Funding & Sponsors
Primary sponsor type
Other
Name
Clinical Evaluation Research Unit at Kingston General Hospital
Address
Country

Ethics approval
Ethics application status

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
Trial website
https://clinicaltrials.gov/study/NCT04931940
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Daren K Heyland, DM
Address 0 0
Clinical Evaluation Research Unit
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Daren K Heyland, DM
Address 0 0
Country 0 0
Phone 0 0
1 403 915-5573
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04931940