The Effect of Higher Protein Dosing in Critically Ill Patients
NCT ID: NCT03160547
Last Updated: 2022-03-28
Study Results
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Basic Information
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COMPLETED
NA
1329 participants
INTERVENTIONAL
2017-11-21
2021-12-03
Brief Summary
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Detailed Description
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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.
The investigator has posed two research questions:
Primary Research Question:
In critically ill patients with nutrition 'risk factors', what is the effect of prescribing a higher dose (≥2.2 grams/kg/day) of protein/amino acid administration compared to a usual dose prescribed ≤1.2 gram/kg/day on time to discharge alive from hospital?
Secondary Research Question:
In critically ill patients with nutrition 'risk factors', what is the effect of prescribing a higher dose (≥2.2 grams/kg/day) of protein/amino acid administration compared to patients prescribed ≤1.2 gram/kg/day on 60 day mortality?
The proposed hypothesis:
Compared to receiving usual 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 a quicker rate of recovery and an improved survival.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Usual Protein/Amino Acid Group
Patients will receive a usual protein/amino acid dose (≤1.2 g/kg/d)
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.
Higher Protein/Amino Acid Group
Patients will receive a higher protein/amino acid dose (≥2.2 g/kg/d).
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
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
Exclusion Criteria
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.
18 Years
ALL
No
Sponsors
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Clinical Evaluation Research Unit at Kingston General Hospital
OTHER
Responsible Party
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Daren K. Heyland
Director
Principal Investigators
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Daren K Heyland, MD
Role: PRINCIPAL_INVESTIGATOR
Clinical Evaluation Research Unit
Locations
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Banner University Medical Center
Phoenix, Arizona, United States
Phoenix VA Health Care System
Phoenix, Arizona, United States
MemorialCare Long Beach Medical Center
Long Beach, California, United States
NorthShore University HealthSystem
Evanston, Illinois, United States
SwedishAmercian.Hospital
Rockford, Illinois, United States
IU Health Methodist Hospital
Indianapolis, Indiana, United States
Lahey Hospital and Medical Center
Burlington, Massachusetts, United States
Spectrum Health
Grand Rapids, Michigan, United States
Virtua
Marlton, New Jersey, United States
Virtua
Mount Holly, New Jersey, United States
Virtua
Voorhees Township, New Jersey, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Fairfield Medical Center
Lancaster, Ohio, United States
OU Medical Center
Oklahoma City, Oklahoma, United States
Hospital of the University of Pennsylvania - MICU
Philadelphia, Pennsylvania, United States
University of Tennessee Medical Center Knoxville
Knoxville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
University of Virginia Health System
Charlottesville, Virginia, United States
Harborview Medical Center
Seattle, Washington, United States
Legacy Salmon Creek Medical Center
Vancouver, Washington, United States
Froedtert Memorial Lutheran Hospital
Milwaukee, Wisconsin, United States
Hospital Britanico de Buenos Aires
Buenos Aires, , Argentina
Sanatorio Allende
Córdoba, , Argentina
Gold Coast Hospital and Health Service
Gold Coast, , Australia
Casa de Saude Sao Jose
Rio de Janeiro, , Brazil
Hospital e Clinica Sao Goncalo
Rio de Janeiro, , Brazil
Hospital Icarai
Rio de Janeiro, , Brazil
Royal Alexandra Hospital
Edmonton, Alberta, Canada
University of Alberta
Edmonton, Alberta, Canada
Abbotsford Regional Hospital
Abbotsford, British Columbia, Canada
Burnaby Hospital
Burnaby, British Columbia, Canada
Royal Columbian Hospital
New Westminster, British Columbia, Canada
Surrey Memorial Hospital
Surrey, British Columbia, Canada
London Health Sciences Center Hospital
London, Ontario, Canada
Grey Bruce Health Services
Owen Sound, Ontario, Canada
Mount Sinai Hospital
Toronto, Ontario, Canada
CIUSSS de l'Est-de-l'ile-de-Montreal- Installation Hospital Maisonneuve-Rosemont
Montreal, Quebec, Canada
Agioi Anargiroi Hospital
Athens, , Greece
Evangelismos General Hospital
Athens, , Greece
Queen Mary Hospital
Hong Kong, , Hong Kong
Apollo Hospitals Enterprises Limited
Mumbai, , India
Emam Reza Hospital, Mashhad University of Medical Science
Mashhad, , Iran
Kobe City Medical Center General Hospital
Kobe, Hyōgo, Japan
National Disaster Medical Center
Tokyo, Midori-cho, Tachikawa-shi, Japan
University of Malaya Medical Centre
Kuala Lumpur, , Malaysia
Hospital San Javier
Guadalajara, Jalisco, Mexico
Hospital Civil Fray Antonio Alcalde
Guadalajara, Jalisco, Mexico
Hospital General Dr. Manuel Gea Gonzalez
Mexico City, Mexico City, Mexico
Hospital Angeles Lomas
México, State of Mexico, Mexico
Hospital Regional Rafael Hernandez L. David Chiriqui Css
David, Chiriquí Province, Panama
Hospital Irma De Lourdes Tzanetatos
Panama City, , Panama
Complejo Hospitalario Dr. Arnulfo Arias Madrid de la Caja de Seguro Social
Panama City, , Panama
Hospital Himas San Pablo Caguas
Caguas, , Puerto Rico
King Faisal Specialist Hospital and Research Center
Riyadh, , Saudi Arabia
University Southampton NHS Trust
Southampton, Hampshire, United Kingdom
Royal Blackburn Hospital
Blackburn, , United Kingdom
North Bristol NHS Trust
Bristol, , United Kingdom
Addenbrooke's Hospital
Cambridge, , United Kingdom
St Richards Hospital
Chichester, , United Kingdom
Northumbria Emergency Care Hospital
Cramlington, , United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, , United Kingdom
Queen Elizabeth Hospital
Gateshead, , United Kingdom
Medway Maritime Hospital
Gillingham, , United Kingdom
Northwick Park hospital
Harrow, , United Kingdom
East Suffolk & North Essex Foundation Trust
Ipswich, , United Kingdom
The Queen Elizabeth Hospital Kings Lynn NHS Trust
Kings Lynn, , United Kingdom
Royal Glamorgan Hospital
Llantrisant, , United Kingdom
Colchester Hospital
London, , United Kingdom
Guy's and St Thomas' NHS Foundation Trust
London, , United Kingdom
Kings College Hospital Denmark Hill
London, , United Kingdom
Queen Elizabeth Hospital
London, , United Kingdom
Royal Free London NHS Foundation Trust
London, , United Kingdom
University Hospital Lewisham
London, , United Kingdom
Queen Elizabeth the Queen Mother Hospital
Margate, , United Kingdom
Freeman Hospital
Newcastle, , United Kingdom
Aneurin bevan University Health Board
Newport, , United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, , United Kingdom
The Tunbridge Wells Hospital
Pembury, , United Kingdom
Queen Alexandra
Portsmouth, , United Kingdom
Royal Preston Hospital
Preston, , United Kingdom
Lister Hospital East and North Hertfordshire Trust
Stevenage, , United Kingdom
Royal Stoke Hospital
Stoke-on-Trent, , United Kingdom
Sunderland Royal Hospital
Sunderland, , United Kingdom
Torbay Hospital
Torquay, , United Kingdom
Worthing Hospital
Worthing, , United Kingdom
Yeovil District Hospital NHS Foundation Trust
Yeovil, , United Kingdom
Countries
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References
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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.
Lew CCH, Lee ZY, Day AG, Jiang X, Bear D, Jensen GL, Ng PY, Tweel L, Parillo A, Heyland DK, Compher C. The Association Between Malnutrition and High Protein Treatment on Outcomes in Critically Ill Patients: A Post Hoc Analysis of the EFFORT Protein Randomized Trial. Chest. 2024 Jun;165(6):1380-1391. doi: 10.1016/j.chest.2024.02.008. Epub 2024 Feb 12.
Haines RW, Prowle JR, Day A, Bear DE, Heyland DK, Puthucheary Z. Association between urea trajectory and protein dose in critically ill adults: a secondary exploratory analysis of the effort protein trial (RE-EFFORT). Crit Care. 2024 Jan 16;28(1):24. doi: 10.1186/s13054-024-04799-1.
Tweel LE, Compher C, Bear DE, Gutierrez-Castrellon P, Leaver SK, MacEachern K, Ortiz-Reyes L, Pooja L, Leon A, Wedemire C, Lee ZY, Day AG, Heyland DK. A Comparison of High and Usual Protein Dosing in Critically Ill Patients With Obesity: A Post Hoc Analysis of an International, Pragmatic, Single-Blinded, Randomized Clinical Trial. Crit Care Med. 2024 Apr 1;52(4):586-595. doi: 10.1097/CCM.0000000000006117. Epub 2023 Nov 6.
Stoppe C, Patel JJ, Zarbock A, Lee ZY, Rice TW, Mafrici B, Wehner R, Chan MHM, Lai PCK, MacEachern K, Myrianthefs P, Tsigou E, Ortiz-Reyes L, Jiang X, Day AG, Hasan MS, Meybohm P, Ke L, Heyland DK. The impact of higher protein dosing on outcomes in critically ill patients with acute kidney injury: a post hoc analysis of the EFFORT protein trial. Crit Care. 2023 Oct 18;27(1):399. doi: 10.1186/s13054-023-04663-8.
Heyland DK, Patel J, Compher C, Rice TW, Bear DE, Lee ZY, Gonzalez VC, O'Reilly K, Regala R, Wedemire C, Ibarra-Estrada M, Stoppe C, Ortiz-Reyes L, Jiang X, Day AG; EFFORT Protein Trial team. The effect of higher protein dosing in critically ill patients with high nutritional risk (EFFORT Protein): an international, multicentre, pragmatic, registry-based randomised trial. Lancet. 2023 Feb 18;401(10376):568-576. doi: 10.1016/S0140-6736(22)02469-2. Epub 2023 Jan 25.
Hill A, Heyland DK, Elke G, Schaller SJ, Stocker R, Haberthur C, von Loeffelholz C, Suchner U, Puthucheary ZA, Bear DE, Ney J, Clasen KC, Meybohm P, Lindau S, Laurentius T, Stoppe C. Meeting nutritional targets of critically ill patients by combined enteral and parenteral nutrition: review and rationale for the EFFORTcombo trial. Nutr Res Rev. 2020 Dec;33(2):312-320. doi: 10.1017/S0954422420000165. Epub 2020 Jul 16.
Provided Documents
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Document Type: Study Protocol and Informed Consent Form
Document Type: Statistical Analysis Plan
Other Identifiers
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The EFFORT Trial
Identifier Type: -
Identifier Source: org_study_id
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