Critical IllnessEFFORTNCT03160547
The Effect of Higher Protein Dosing in Critically Ill Patients
A study testing Usual Protein/Amino Acid Group and Higher Protein/Amino Acid Group in people with Critical Illness and Malnutrition, run by Clinical Evaluation Research Unit at Kingston General Hospital at 86 sites in 16 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Malnutrition
- What is being tested?
- Usual Protein/Amino Acid Group and Higher Protein/Amino Acid Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,329 participants
- Where
- 86 sitesin 16 countries
- Study dates
- 21 Nov 2017to 3 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years old
- Nutritionally 'high-risk' (meeting one of the below criteria)
- Low (≤25) or High BMI (≥35)
- 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.).
- Frailty (Clinical Frailty Scale 5 or more from proxy)
- Sarcopenia- (SARC-F score of 4 or more from proxy)
- From point of screening, projected duration of mechanical ventilation >4 days
- Requiring mechanical ventilation with actual or expected total duration of mechanical ventilation >48 hours
Who cannot join
- >96 continuous hours of mechanical ventilation before screening
- Expected death or withdrawal of life-sustaining treatments within 7 days from screening
- Pregnant
- The responsible clinician feels that the patient either needs low or high protein
- Patient requires parenteral nutrition only and site does not have products to reach the high protein dose group.
Trial locations and contacts
86 sites in 16 countries.
86 sites in 16 countries
United Kingdom32 sites
Royal Blackburn Hospital
Blackburn
North Bristol NHS Trust
Bristol
Addenbrooke's Hospital
Cambridge
St Richards Hospital
Chichester
Northumbria Emergency Care Hospital
Cramlington
Royal Infirmary of Edinburgh
Edinburgh
Queen Elizabeth Hospital
Gateshead
Medway Maritime Hospital
Gillingham
Northwick Park hospital
Harrow
East Suffolk & North Essex Foundation Trust
Ipswich
The Queen Elizabeth Hospital Kings Lynn NHS Trust
Kings Lynn
Royal Glamorgan Hospital
Llantrisant
Colchester Hospital
London
Guy's and St Thomas' NHS Foundation Trust
London
Kings College Hospital Denmark Hill
London
Queen Elizabeth Hospital
London
Royal Free London NHS Foundation Trust
London
University Hospital Lewisham
London
Queen Elizabeth the Queen Mother Hospital
Margate
Freeman Hospital
Newcastle
Aneurin bevan University Health Board
Newport
Nottingham University Hospitals NHS Trust
Nottingham
The Tunbridge Wells Hospital
Pembury
Queen Alexandra
Portsmouth
Royal Preston Hospital
Preston
University Southampton NHS Trust
Southampton, Hampshire
Lister Hospital East and North Hertfordshire Trust
Stevenage
Royal Stoke Hospital
Stoke-on-Trent
Sunderland Royal Hospital
Sunderland
Torbay Hospital
Torquay
Worthing Hospital
Worthing
Yeovil District Hospital NHS Foundation Trust
Yeovil
United States21 sites
Lahey Hospital and Medical Center
Burlington, Massachusetts, 01805
University of Virginia Health System
Charlottesville, Virginia, 22901
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
NorthShore University HealthSystem
Evanston, Illinois, 60077
Spectrum Health
Grand Rapids, Michigan, 49503
IU Health Methodist Hospital
Indianapolis, Indiana, 46202
University of Tennessee Medical Center Knoxville
Knoxville, Tennessee, 37920
Fairfield Medical Center
Lancaster, Ohio, 43130
MemorialCare Long Beach Medical Center
Long Beach, California, 90712
Virtua
Marlton, New Jersey, 08053
Froedtert Memorial Lutheran Hospital
Milwaukee, Wisconsin, 53226
Virtua
Mount Holly, New Jersey, 28012
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
OU Medical Center
Oklahoma City, Oklahoma, 73104
Hospital of the University of Pennsylvania - MICU
Philadelphia, Pennsylvania, 19104
Banner University Medical Center
Phoenix, Arizona, 85006
Phoenix VA Health Care System
Phoenix, Arizona, 85012
SwedishAmercian.Hospital
Rockford, Illinois, 61104
Harborview Medical Center
Seattle, Washington, 98104
Legacy Salmon Creek Medical Center
Vancouver, Washington, 98686
Virtua
Voorhees Township, New Jersey, 08043
Canada10 sites
Abbotsford Regional Hospital
Abbotsford British Columbia, British Columbia
Burnaby Hospital
Burnaby, British Columbia
Royal Alexandra Hospital
Edmonton, Alberta, 869
University of Alberta
Edmonton, Alberta, 900
London Health Sciences Center Hospital
London, Ontario
CIUSSS de l'Est-de-l'ile-de-Montreal- Installation Hospital Maisonneuve-Rosemont
Montreal, Quebec, 547
Royal Columbian Hospital
New Westminster, British Columbia
Grey Bruce Health Services
Owen Sound, Ontario, N4K 6M9
Surrey Memorial Hospital
Surrey, British Columbia
Mount Sinai Hospital
Toronto, Ontario, 442
Mexico4 sites
Hospital San Javier
Guadalajara, Jalisco, 44670
Hospital Civil Fray Antonio Alcalde
Guadalajara, Jalisco, 964
Hospital Angeles Lomas
México, State of Mexico, 165
Hospital General Dr. Manuel Gea Gonzalez
Mexico City, Mexico City, 298
Brazil3 sites
Casa de Saude Sao Jose
Rio de Janeiro, 200
Hospital e Clinica Sao Goncalo
Rio de Janeiro, 211
Hospital Icarai
Rio de Janeiro, 222
Panama3 sites
Hospital Regional Rafael Hernandez L. David Chiriqui Css
David, Chiriquí Province, 330
Hospital Irma De Lourdes Tzanetatos
Panama City, 200
Complejo Hospitalario Dr. Arnulfo Arias Madrid de la Caja de Seguro Social
Panama City, 50
Argentina2 sites
Hospital Britanico de Buenos Aires
Buenos Aires, C1280AEB CABA
Sanatorio Allende
Córdoba, 260
Greece2 sites
Agioi Anargiroi Hospital
Athens
Evangelismos General Hospital
Athens
Japan2 sites
Kobe City Medical Center General Hospital
Kobe, Hyōgo, 768
National Disaster Medical Center
Tokyo, Midori-cho, Tachikawa-shi, 3256
Saudi Arabia1 site
King Faisal Specialist Hospital and Research Center
Riyadh
About this study
Official title: The Effect of Higher Protein Dosing in Critically Ill Patients: A Multicenter Registry-based Randomized Trial
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.
Read the detailed description
The EFFORT Study is a multi-center, pragmatic, volunteer-driven, registry-based, randomized, clinical trial of 4000 nutritionally high-risk critically ill patients in the intensive care unit (ICU). We anticipate over 100 sites participating internationally, with each site enrolling a minimum of 30 patients. Patients will be randomized to 1 of 2 treatment groups: a usual 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.
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
- Critical Illness, Malnutrition
- Being tested
- Usual Protein/Amino Acid Group, Higher Protein/Amino Acid Group
- Medical subject headings
- Critical Illness, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual Protein/Amino Acid GroupOther
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 GroupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual Protein/Amino Acid Group | Active comparator | Patients will receive a usual protein/amino acid dose (≤1.2 g/kg/d) Receives: Other: Usual Protein/Amino Acid Group |
| Higher Protein/Amino Acid Group | Active comparator | Patients will receive a higher protein/amino acid dose (≥2.2 g/kg/d). Receives: Other: Higher Protein/Amino Acid Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to discharge alive from hospital
This is a composite of mortality and length of stay, evaluated up to 60 days post randomization
Measured: 60 day
Secondary outcomes (1)
60-day mortality
Mortality 60 days post randomization
Measured: 60 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2017
- Study start21 Nov 2017
- Primary completion3 Dec 2021
- Study completion3 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,329 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinical Evaluation Research Unit at Kingston General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daren K. Heyland, Clinical Evaluation Research Unit at Kingston General Hospital
- Investigators
- Daren K Heyland, MD, Principal investigator, Clinical Evaluation Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03160547
- Sponsor's protocol ID
- The EFFORT Trial
- Acronym
- EFFORT
- Status last verified
- Mar 2022
- First submitted
- 17 May 2017
- Last updated
- 28 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 22811443Heyland 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.
PubMed 21705881Jolly 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.
PubMed 25853743Fan 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.
PubMed 24247473De 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.
PubMed 12472328Hermans 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.
PubMed 24825371Tweel LE, Brody R, Samavat H, Day AG, Jiang X, Byham-Gray L, Patel J, Compher C, Heyland DK. Association between protein dose in the early and late acute phases of critical illness and time-to-discharge-alive: A secondary analysis of a randomized clinical trial. JPEN J Parenter Enteral Nutr. 2026 Feb;50(2):183-191. doi: 10.1002/jpen.70033. Epub 2025 Nov 14.
PubMed 41236842Lew 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.
PubMed 38354904Haines 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.
PubMed 38229072Tweel 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.
PubMed 37930244Stoppe 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.
PubMed 37853490Heyland 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.
PubMed 36708732Hill 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.
PubMed 32669140
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Higher Protein Dosing in Critically Ill Patients: A Multicenter Registry-based Randomized Trial
- ClinicalTrials.gov ID
- NCT03160547
- Acronym / sponsor ID
- EFFORT / The EFFORT Trial
- Conditions
- Critical Illness, Malnutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,329 participants (actual)
- Lead sponsor
- Clinical Evaluation Research Unit at Kingston General HospitalUniversity, hospital or other
- Study start
- 21 Nov 2017 (actual)
- Primary completion
- 3 Dec 2021 (actual)
- Study completion
- 3 Dec 2021 (actual)
- First posted
- 19 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The EFFORT Study is a multi-center, pragmatic, volunteer-driven, registry-based, randomized, clinical trial of 4000 nutritionally high-risk critically ill patients in the intensive care unit (ICU). We anticipate over 100 sites participating internationally, with each site enrolling a minimum of 30 patients. Patients will be randomized to 1 of 2 treatment groups: a usual 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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Protein/Amino Acid Group | Active comparator | Other: Usual Protein/Amino Acid GroupPatients will receive a usual protein/amino acid dose (≤1.2 g/kg/d) |
| Higher Protein/Amino Acid Group | Active comparator | Other: Higher Protein/Amino Acid GroupPatients will receive a higher protein/amino acid dose (≥2.2 g/kg/d). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- ≥18 years old
- Nutritionally 'high-risk' (meeting one of the below criteria)
- Requiring mechanical ventilation with actual or expected total duration of mechanical ventilation >48 hours
Key exclusion criteria (5 listed)
- >96 continuous hours of mechanical ventilation before screening
- Expected death or withdrawal of life-sustaining treatments within 7 days from screening
- Pregnant
- The responsible clinician feels that the patient either needs low or high protein
- Patient requires parenteral nutrition only and site does not have products to reach the high protein dose group.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual Protein/Amino Acid GroupProtein 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 | Usual Protein/Amino Acid Group |
| Higher Protein/Amino Acid GroupProtein 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 | Higher Protein/Amino Acid Group |
Primary outcome
Time to discharge alive from hospital
Time frame: 60 day
This is a composite of mortality and length of stay, evaluated up to 60 days post randomization
1 secondary outcome
60-day mortality
Time frame: 60 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2022.
- Background: PubMed 22811443Hoffer 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.
- Background: PubMed 21705881Heyland 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.
- Background: PubMed 25853743Jolly 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.
- Background: PubMed 24247473Fan 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.
- Background: PubMed 12472328De 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.
- Background: PubMed 24825371Hermans 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.
- Derived from this study: PubMed 41236842Tweel LE, Brody R, Samavat H, Day AG, Jiang X, Byham-Gray L, Patel J, Compher C, Heyland DK. Association between protein dose in the early and late acute phases of critical illness and time-to-discharge-alive: A secondary analysis of a randomized clinical trial. JPEN J Parenter Enteral Nutr. 2026 Feb;50(2):183-191. doi: 10.1002/jpen.70033. Epub 2025 Nov 14.
- Derived from this study: PubMed 38354904Lew 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.
- Derived from this study: PubMed 38229072Haines 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.
- Derived from this study: PubMed 37930244Tweel 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.
- Derived from this study: PubMed 37853490Stoppe 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.
- Derived from this study: PubMed 36708732Heyland 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daren K Heyland, MD principal investigator
Clinical Evaluation Research Unit
86 sites in 16 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Usual Protein/Amino Acid Group and Higher Protein/Amino Acid Group in people with Critical Illness and Malnutrition, run by Clinical Evaluation Research Unit at Kingston General Hospital at 86 sites in 16 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 86 sites in United Kingdom, United States, Canada, Mexico, Brazil and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to discharge alive from hospital (time frame: 60 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03160547, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2022.