Back to resultsThe Effect of Higher Protein Dosing in Critically Ill Patients (EFFORT)
Primary Purpose
Critical Illness, Malnutrition
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Usual Protein/Amino Acid Group
Higher Protein/Amino Acid Group
Sponsored by
About this trial
This is an interventional basic science trial for Critical Illness
Eligibility Criteria
Inclusion Criteria:
- ≥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
Exclusion Criteria:
- >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.
Sites / Locations
- Banner University Medical Center
- Phoenix VA Health Care System
- MemorialCare Long Beach Medical Center
- NorthShore University HealthSystem
- SwedishAmercian.Hospital
- IU Health Methodist Hospital
- Lahey Hospital and Medical Center
- Spectrum Health
- Virtua
- Virtua
- Virtua
- The Ohio State University Wexner Medical Center
- Fairfield Medical Center
- OU Medical Center
- Hospital of the University of Pennsylvania - MICU
- University of Tennessee Medical Center Knoxville
- Vanderbilt University Medical Center
- University of Virginia Health System
- Harborview Medical Center
- Legacy Salmon Creek Medical Center
- Froedtert Memorial Lutheran Hospital
- Hospital Britanico de Buenos Aires
- Sanatorio Allende
- Gold Coast Hospital and Health Service
- Casa de Saude Sao Jose
- Hospital e Clinica Sao Goncalo
- Hospital Icarai
- Royal Alexandra Hospital
- University of Alberta
- Abbotsford Regional Hospital
- Burnaby Hospital
- Royal Columbian Hospital
- Surrey Memorial Hospital
- London Health Sciences Center Hospital
- Grey Bruce Health Services
- Mount Sinai Hospital
- CIUSSS de l'Est-de-l'ile-de-Montreal- Installation Hospital Maisonneuve-Rosemont
- Agioi Anargiroi Hospital
- Evangelismos General Hospital
- Queen Mary Hospital
- Apollo Hospitals Enterprises Limited
- Emam Reza Hospital, Mashhad University of Medical Science
- Kobe City Medical Center General Hospital
- National Disaster Medical Center
- University of Malaya Medical Centre
- Hospital General Dr. Manuel Gea Gonzalez
- Hospital Angeles Lomas
- Hospital San Javier
- Hospital Civil Fray Antonio Alcalde
- Hospital Regional Rafael Hernandez L. David Chiriqui Css
- Hospital Irma De Lourdes Tzanetatos
- Complejo Hospitalario Dr. Arnulfo Arias Madrid de la Caja de Seguro Social
- Hospital Himas San Pablo Caguas
- King Faisal Specialist Hospital and Research Center
- University Southampton NHS Trust
- Royal Blackburn Hospital
- North Bristol NHS Trust
- Addenbrooke's Hospital
- St Richards Hospital
- Northumbria Emergency Care Hospital
- Royal Infirmary of Edinburgh
- Queen Elizabeth Hospital
- Medway Maritime Hospital
- Northwick Park hospital
- East Suffolk & North Essex Foundation Trust
- The Queen Elizabeth Hospital Kings Lynn NHS Trust
- Royal Glamorgan Hospital
- Colchester Hospital
- Guy's and St Thomas' NHS Foundation Trust
- Kings College Hospital Denmark Hill
- Queen Elizabeth Hospital
- Royal Free London NHS Foundation Trust
- University Hospital Lewisham
- Queen Elizabeth the Queen Mother Hospital
- Freeman Hospital
- Aneurin bevan University Health Board
- Nottingham University Hospitals NHS Trust
- The Tunbridge Wells Hospital
- Queen Alexandra
- Royal Preston Hospital
- Lister Hospital East and North Hertfordshire Trust
- Royal Stoke Hospital
- Sunderland Royal Hospital
- Torbay Hospital
- Worthing Hospital
- Yeovil District Hospital NHS Foundation Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Usual Protein/Amino Acid Group
Higher Protein/Amino Acid Group
Arm Description
Patients will receive a usual protein/amino acid dose (≤1.2 g/kg/d)
Patients will receive a higher protein/amino acid dose (≥2.2 g/kg/d).
Outcomes
Primary Outcome Measures
Time to discharge alive from hospital
This is a composite of mortality and length of stay, evaluated up to 60 days post randomization
Secondary Outcome Measures
60-day mortality
Mortality 60 days post randomization
Full Information
NCT ID
NCT03160547
First Posted
May 17, 2017
Last Updated
March 25, 2022
Sponsor
Clinical Evaluation Research Unit at Kingston General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03160547
Brief Title
The Effect of Higher Protein Dosing in Critically Ill Patients
Acronym
EFFORT
Official Title
The Effect of Higher Protein Dosing in Critically Ill Patients: A Multicenter Registry-based Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
November 21, 2017 (Actual)
Primary Completion Date
December 3, 2021 (Actual)
Study Completion Date
December 3, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Clinical Evaluation Research Unit at Kingston General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness, Malnutrition
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1329 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Usual Protein/Amino Acid Group
Arm Type
Active Comparator
Arm Description
Patients will receive a usual protein/amino acid dose (≤1.2 g/kg/d)
Arm Title
Higher Protein/Amino Acid Group
Arm Type
Active Comparator
Arm Description
Patients will receive a higher protein/amino acid dose (≥2.2 g/kg/d).
Intervention Type
Other
Intervention Name(s)
Usual Protein/Amino Acid Group
Intervention Description
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 Type
Other
Intervention Name(s)
Higher Protein/Amino Acid Group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time to discharge alive from hospital
Description
This is a composite of mortality and length of stay, evaluated up to 60 days post randomization
Time Frame
60 day
Secondary Outcome Measure Information:
Title
60-day mortality
Description
Mortality 60 days post randomization
Time Frame
60 day
Other Pre-specified Outcome Measures:
Title
Nutritional Adequacy
Description
To be evaluated up to 60 days post randomization
Time Frame
60 day
Title
Hospital mortality
Description
To be evaluated up to 60 days post randomization
Time Frame
60 day
Title
Readmission to ICU and Hospital
Description
To be evaluated up to 60 days post randomization
Time Frame
60 day
Title
Duration of Mechanical Ventilation
Description
To be evaluated up to 60 days post randomization
Time Frame
60 day
Title
ICU length of stay
Description
To be evaluated up to 60 days post randomization
Time Frame
60 day
Title
Hospital length of stay
Description
To be evaluated up to 60 days post randomization
Time Frame
60 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
≥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
Exclusion Criteria:
>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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daren K Heyland, MD
Organizational Affiliation
Clinical Evaluation Research Unit
Official's Role
Principal Investigator
Facility Information:
Facility Name
Banner University Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Phoenix VA Health Care System
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
Facility Name
MemorialCare Long Beach Medical Center
City
Long Beach
State/Province
California
ZIP/Postal Code
90712
Country
United States
Facility Name
NorthShore University HealthSystem
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60077
Country
United States
Facility Name
SwedishAmercian.Hospital
City
Rockford
State/Province
Illinois
ZIP/Postal Code
61104
Country
United States
Facility Name
IU Health Methodist Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Lahey Hospital and Medical Center
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
Facility Name
Spectrum Health
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Virtua
City
Marlton
State/Province
New Jersey
ZIP/Postal Code
08053
Country
United States
Facility Name
Virtua
City
Mount Holly
State/Province
New Jersey
ZIP/Postal Code
28012
Country
United States
Facility Name
Virtua
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
The Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Fairfield Medical Center
City
Lancaster
State/Province
Ohio
ZIP/Postal Code
43130
Country
United States
Facility Name
OU Medical Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Hospital of the University of Pennsylvania - MICU
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Tennessee Medical Center Knoxville
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
University of Virginia Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22901
Country
United States
Facility Name
Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Legacy Salmon Creek Medical Center
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98686
Country
United States
Facility Name
Froedtert Memorial Lutheran Hospital
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Hospital Britanico de Buenos Aires
City
Buenos Aires
ZIP/Postal Code
C1280AEB CABA
Country
Argentina
Facility Name
Sanatorio Allende
City
Cordoba
ZIP/Postal Code
260
Country
Argentina
Facility Name
Gold Coast Hospital and Health Service
City
Gold Coast
Country
Australia
Facility Name
Casa de Saude Sao Jose
City
Rio de Janeiro
ZIP/Postal Code
200
Country
Brazil
Facility Name
Hospital e Clinica Sao Goncalo
City
Rio de Janeiro
ZIP/Postal Code
211
Country
Brazil
Facility Name
Hospital Icarai
City
Rio de Janeiro
ZIP/Postal Code
222
Country
Brazil
Facility Name
Royal Alexandra Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
869
Country
Canada
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
900
Country
Canada
Facility Name
Abbotsford Regional Hospital
City
Abbotsford
State/Province
British Columbia
Country
Canada
Facility Name
Burnaby Hospital
City
Burnaby
State/Province
British Columbia
Country
Canada
Facility Name
Royal Columbian Hospital
City
New Westminster
State/Province
British Columbia
Country
Canada
Facility Name
Surrey Memorial Hospital
City
Surrey
State/Province
British Columbia
Country
Canada
Facility Name
London Health Sciences Center Hospital
City
London
State/Province
Ontario
Country
Canada
Facility Name
Grey Bruce Health Services
City
Owen Sound
State/Province
Ontario
ZIP/Postal Code
N4K 6M9
Country
Canada
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
442
Country
Canada
Facility Name
CIUSSS de l'Est-de-l'ile-de-Montreal- Installation Hospital Maisonneuve-Rosemont
City
Montreal
State/Province
Quebec
ZIP/Postal Code
547
Country
Canada
Facility Name
Agioi Anargiroi Hospital
City
Athens
Country
Greece
Facility Name
Evangelismos General Hospital
City
Athens
Country
Greece
Facility Name
Queen Mary Hospital
City
Hong Kong
ZIP/Postal Code
1400
Country
Hong Kong
Facility Name
Apollo Hospitals Enterprises Limited
City
Mumbai
Country
India
Facility Name
Emam Reza Hospital, Mashhad University of Medical Science
City
Mashhad
Country
Iran, Islamic Republic of
Facility Name
Kobe City Medical Center General Hospital
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
768
Country
Japan
Facility Name
National Disaster Medical Center
City
Tokyo
State/Province
Midori-cho, Tachikawa-shi
ZIP/Postal Code
3256
Country
Japan
Facility Name
University of Malaya Medical Centre
City
Kuala Lumpur
Country
Malaysia
Facility Name
Hospital General Dr. Manuel Gea Gonzalez
City
Mexico City
State/Province
Cdmx
ZIP/Postal Code
298
Country
Mexico
Facility Name
Hospital Angeles Lomas
City
Mexico City
State/Province
Estado De Mexico
ZIP/Postal Code
165
Country
Mexico
Facility Name
Hospital San Javier
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44670
Country
Mexico
Facility Name
Hospital Civil Fray Antonio Alcalde
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
964
Country
Mexico
Facility Name
Hospital Regional Rafael Hernandez L. David Chiriqui Css
City
David
State/Province
Chiriqui
ZIP/Postal Code
330
Country
Panama
Facility Name
Hospital Irma De Lourdes Tzanetatos
City
Panamá
ZIP/Postal Code
200
Country
Panama
Facility Name
Complejo Hospitalario Dr. Arnulfo Arias Madrid de la Caja de Seguro Social
City
Panamá
ZIP/Postal Code
50
Country
Panama
Facility Name
Hospital Himas San Pablo Caguas
City
Caguas
ZIP/Postal Code
440
Country
Puerto Rico
Facility Name
King Faisal Specialist Hospital and Research Center
City
Riyadh
Country
Saudi Arabia
Facility Name
University Southampton NHS Trust
City
Southampton
State/Province
Hampshire
Country
United Kingdom
Facility Name
Royal Blackburn Hospital
City
Blackburn
Country
United Kingdom
Facility Name
North Bristol NHS Trust
City
Bristol
Country
United Kingdom
Facility Name
Addenbrooke's Hospital
City
Cambridge
Country
United Kingdom
Facility Name
St Richards Hospital
City
Chichester
Country
United Kingdom
Facility Name
Northumbria Emergency Care Hospital
City
Cramlington
Country
United Kingdom
Facility Name
Royal Infirmary of Edinburgh
City
Edinburgh
Country
United Kingdom
Facility Name
Queen Elizabeth Hospital
City
Gateshead
Country
United Kingdom
Facility Name
Medway Maritime Hospital
City
Gillingham
Country
United Kingdom
Facility Name
Northwick Park hospital
City
Harrow
Country
United Kingdom
Facility Name
East Suffolk & North Essex Foundation Trust
City
Ipswich
Country
United Kingdom
Facility Name
The Queen Elizabeth Hospital Kings Lynn NHS Trust
City
King's Lynn
Country
United Kingdom
Facility Name
Royal Glamorgan Hospital
City
Llantrisant
Country
United Kingdom
Facility Name
Colchester Hospital
City
London
Country
United Kingdom
Facility Name
Guy's and St Thomas' NHS Foundation Trust
City
London
Country
United Kingdom
Facility Name
Kings College Hospital Denmark Hill
City
London
Country
United Kingdom
Facility Name
Queen Elizabeth Hospital
City
London
Country
United Kingdom
Facility Name
Royal Free London NHS Foundation Trust
City
London
Country
United Kingdom
Facility Name
University Hospital Lewisham
City
London
Country
United Kingdom
Facility Name
Queen Elizabeth the Queen Mother Hospital
City
Margate
Country
United Kingdom
Facility Name
Freeman Hospital
City
Newcastle
Country
United Kingdom
Facility Name
Aneurin bevan University Health Board
City
Newport
Country
United Kingdom
Facility Name
Nottingham University Hospitals NHS Trust
City
Nottingham
Country
United Kingdom
Facility Name
The Tunbridge Wells Hospital
City
Pembury
Country
United Kingdom
Facility Name
Queen Alexandra
City
Portsmouth
Country
United Kingdom
Facility Name
Royal Preston Hospital
City
Preston
Country
United Kingdom
Facility Name
Lister Hospital East and North Hertfordshire Trust
City
Stevenage
Country
United Kingdom
Facility Name
Royal Stoke Hospital
City
Stoke-on-Trent
Country
United Kingdom
Facility Name
Sunderland Royal Hospital
City
Sunderland
Country
United Kingdom
Facility Name
Torbay Hospital
City
Torquay
Country
United Kingdom
Facility Name
Worthing Hospital
City
Worthing
Country
United Kingdom
Facility Name
Yeovil District Hospital NHS Foundation Trust
City
Yeovil
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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The Effect of Higher Protein Dosing in Critically Ill Patients
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