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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/NCT03160547




Registration number
NCT03160547
Ethics application status
Date submitted
17/05/2017
Date registered
19/05/2017
Date last updated
28/03/2022

Titles & IDs
Public title
The Effect of Higher Protein Dosing in Critically Ill Patients
Scientific title
The Effect of Higher Protein Dosing in Critically Ill Patients: A Multicenter Registry-based Randomized Trial
Secondary ID [1] 0 0
The EFFORT Trial
Universal Trial Number (UTN)
Trial acronym
EFFORT
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
Other interventions - Usual Protein/Amino Acid Group
Other interventions - Higher Protein/Amino Acid Group

Active Comparator: Usual Protein/Amino Acid Group - 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 Protein/Amino Acid Group
Protein targets will be set using pre-ICU dry actual weight. For patients with BMI >30, ideal body weight based on a BMI of 25 will be used. We will endorse the guidelines for energy targets set forth by ASPEN/SCCM, especially as it pertains to the obese patient.

Other interventions: Higher Protein/Amino Acid Group
Protein targets will be set using pre-ICU dry actual weight. For patients with BMI >30, ideal body weight based on a BMI of 25 will be used. We will endorse the guidelines for energy targets set forth by ASPEN/SCCM, especially as it pertains to the obese patient.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to discharge alive from hospital
Timepoint [1] 0 0
60 day
Secondary outcome [1] 0 0
60-day mortality
Timepoint [1] 0 0
60 day

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.

Study design
Purpose of the study
Basic Science
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/11/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
3/12/2021
Sample size
Target
Accrual to date
Final
1329
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
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United States of America
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Arizona
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United States of America
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California
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Illinois
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Indiana
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Massachusetts
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Michigan
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New Jersey
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Ohio
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Oklahoma
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Pennsylvania
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Tennessee
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Virginia
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Washington
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Wisconsin
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Argentina
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Buenos Aires
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Argentina
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Cordoba
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Brazil
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Rio de Janeiro
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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Ontario
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Canada
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Quebec
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Greece
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Athens
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Hong Kong
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Hong Kong
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India
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Mumbai
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Iran, Islamic Republic of
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Mashhad
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Japan
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Hyogo
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Japan
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Midori-cho, Tachikawa-shi
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Malaysia
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Kuala Lumpur
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Mexico
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Cdmx
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Mexico
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Estado De Mexico
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Mexico
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Jalisco
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Panama
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Chiriqui
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Panama
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Panamá
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Puerto Rico
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Caguas
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Saudi Arabia
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Riyadh
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United Kingdom
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Hampshire
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United Kingdom
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Blackburn
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United Kingdom
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Bristol
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United Kingdom
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Cambridge
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Chichester
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United Kingdom
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Cramlington
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Edinburgh
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United Kingdom
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Gateshead
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United Kingdom
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Gillingham
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United Kingdom
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Harrow
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United Kingdom
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Ipswich
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United Kingdom
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King's Lynn
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United Kingdom
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Llantrisant
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United Kingdom
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London
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United Kingdom
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Margate
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United Kingdom
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Newcastle
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Newport
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Nottingham
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Pembury
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Portsmouth
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Preston
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Stevenage
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Stoke-on-Trent
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United Kingdom
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Sunderland
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United Kingdom
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Torquay
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United Kingdom
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Worthing
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United Kingdom
State/province [62] 0 0
Yeovil

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 investigator will investigate the effects of higher protein/amino acid dosing (=2.2
g/kg/d) vs usual protein/amino acid dosing (=1.2 g/kg/d) on clinical outcomes in
nutritionally high risk ill patients.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03160547
Trial related presentations / publications
Hoffer LJ, Bistrian BR. Appropriate protein provision in critical illness: a systematic and narrative review. Am J Clin Nutr. 2012 Sep;96(3):591-600. doi: 10.3945/ajcn.111.032078. Epub 2012 Jul 18.
Heyland DK, Cahill N, Day AG. Optimal amount of calories for critically ill patients: depends on how you slice the cake! Crit Care Med. 2011 Dec;39(12):2619-26. doi: 10.1097/CCM.0b013e318226641d.
Jolly SS, Cairns JA, Yusuf S, Meeks B, Pogue J, Rokoss MJ, Kedev S, Thabane L, Stankovic G, Moreno R, Gershlick A, Chowdhary S, Lavi S, Niemela K, Steg PG, Bernat I, Xu Y, Cantor WJ, Overgaard CB, Naber CK, Cheema AN, Welsh RC, Bertrand OF, Avezum A, Bhindi R, Pancholy S, Rao SV, Natarajan MK, ten Berg JM, Shestakovska O, Gao P, Widimsky P, Dzavik V; TOTAL Investigators. Randomized trial of primary PCI with or without routine manual thrombectomy. N Engl J Med. 2015 Apr 9;372(15):1389-98. doi: 10.1056/NEJMoa1415098. Epub 2015 Mar 16.
Fan E, Dowdy DW, Colantuoni E, Mendez-Tellez PA, Sevransky JE, Shanholtz C, Himmelfarb CR, Desai SV, Ciesla N, Herridge MS, Pronovost PJ, Needham DM. Physical complications in acute lung injury survivors: a two-year longitudinal prospective study. Crit Care Med. 2014 Apr;42(4):849-59. doi: 10.1097/CCM.0000000000000040.
De Jonghe B, Sharshar T, Lefaucheur JP, Authier FJ, Durand-Zaleski I, Boussarsar M, Cerf C, Renaud E, Mesrati F, Carlet J, Raphael JC, Outin H, Bastuji-Garin S; Groupe de Reflexion et d'Etude des Neuromyopathies en Reanimation. Paresis acquired in the intensive care unit: a prospective multicenter study. JAMA. 2002 Dec 11;288(22):2859-67. doi: 10.1001/jama.288.22.2859.
Hermans G, Van Mechelen H, Clerckx B, Vanhullebusch T, Mesotten D, Wilmer A, Casaer MP, Meersseman P, Debaveye Y, Van Cromphaut S, Wouters PJ, Gosselink R, Van den Berghe G. Acute outcomes and 1-year mortality of intensive care unit-acquired weakness. A cohort study and propensity-matched analysis. Am J Respir Crit Care Med. 2014 Aug 15;190(4):410-20. doi: 10.1164/rccm.201312-2257OC.
Public notes

Contacts
Principal investigator
Name 0 0
Daren K Heyland, MD
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries