The Effect of Higher Protein Dosing in Critically Ill Patients (EFFORT)

March 25, 2022 updated by: Daren K. Heyland, Clinical Evaluation Research Unit at Kingston General Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1329

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1280AEB CABA
        • Hospital Britanico de Buenos Aires
      • Cordoba, Argentina, 260
        • Sanatorio Allende
  • Australia
      • Gold Coast, Australia
        • Gold Coast Hospital and Health Service
  • Brazil
      • Rio de Janeiro, Brazil, 200
        • Casa de Saude Sao Jose
      • Rio de Janeiro, Brazil, 211
        • Hospital e Clínica São Gonçalo
      • Rio de Janeiro, Brazil, 222
        • Hospital Icarai
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, 869
        • Royal Alexandra Hospital
      • Edmonton, Alberta, Canada, 900
        • University of Alberta
    • British Columbia
      • Abbotsford, British Columbia, Canada
        • Abbotsford Regional Hospital
      • Burnaby, British Columbia, Canada
        • Burnaby Hospital
      • New Westminster, British Columbia, Canada
        • Royal Columbian Hospital
      • Surrey, British Columbia, Canada
        • Surrey Memorial Hospital
    • Ontario
      • London, Ontario, Canada
        • London Health Sciences Center Hospital
      • Owen Sound, Ontario, Canada, N4K 6M9
        • Grey Bruce Health Services
      • Toronto, Ontario, Canada, 442
        • Mount Sinai Hospital
    • Quebec
      • Montreal, Quebec, Canada, 547
        • CIUSSS de l'Est-de-l'ile-de-Montreal- Installation Hospital Maisonneuve-Rosemont
  • Greece
      • Athens, Greece
        • Agioi Anargiroi Hospital
      • Athens, Greece
        • Evangelismos General Hospital
  • Hong Kong
      • Hong Kong, Hong Kong, 1400
        • Queen Mary Hospital
  • India
      • Mumbai, India
        • Apollo Hospitals Enterprises Limited
  • Iran, Islamic Republic of
      • Mashhad, Iran, Islamic Republic of
        • Emam Reza Hospital, Mashhad University of Medical Science
  • Japan
    • Hyogo
      • Kobe, Hyogo, Japan, 768
        • Kobe City Medical Center General Hospital
    • Midori-cho, Tachikawa-shi
      • Tokyo, Midori-cho, Tachikawa-shi, Japan, 3256
        • National Disaster Medical Center
  • Malaysia
      • Kuala Lumpur, Malaysia
        • University of Malaya Medical Centre
  • Mexico
    • Cdmx
      • Mexico City, Cdmx, Mexico, 298
        • Hospital General Dr. Manuel Gea González
    • Estado De Mexico
      • Mexico City, Estado De Mexico, Mexico, 165
        • Hospital Angeles Lomas
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44670
        • Hospital San Javier
      • Guadalajara, Jalisco, Mexico, 964
        • Hospital Civil Fray Antonio Alcalde
  • Panama
      • Panamá, Panama, 200
        • Hospital Irma De Lourdes Tzanetatos
      • Panamá, Panama, 50
        • Complejo Hospitalario Dr. Arnulfo Arias Madrid de la Caja de Seguro Social
    • Chiriqui
      • David, Chiriqui, Panama, 330
        • Hospital Regional Rafael Hernandez L. David Chiriqui Css
  • Puerto Rico
      • Caguas, Puerto Rico, 440
        • Hospital Himas San Pablo Caguas
  • Saudi Arabia
      • Riyadh, Saudi Arabia
        • King Faisal Specialist Hospital and Research Center
  • United Kingdom
      • Blackburn, United Kingdom
        • Royal Blackburn Hospital
      • Bristol, United Kingdom
        • North Bristol NHS Trust
      • Cambridge, United Kingdom
        • Addenbrooke's Hospital
      • Chichester, United Kingdom
        • St Richards Hospital
      • Cramlington, United Kingdom
        • Northumbria Emergency Care Hospital
      • Edinburgh, United Kingdom
        • Royal Infirmary of Edinburgh
      • Gateshead, United Kingdom
        • Queen Elizabeth Hospital
      • Gillingham, United Kingdom
        • Medway Maritime Hospital
      • Harrow, United Kingdom
        • Northwick Park Hospital
      • Ipswich, United Kingdom
        • East Suffolk & North Essex Foundation Trust
      • King's Lynn, United Kingdom
        • The Queen Elizabeth Hospital Kings Lynn NHS Trust
      • Llantrisant, United Kingdom
        • Royal Glamorgan Hospital
      • London, United Kingdom
        • Queen Elizabeth Hospital
      • London, United Kingdom
        • Royal Free London NHS Foundation Trust
      • London, United Kingdom
        • Guy's and St Thomas' NHS Foundation Trust
      • London, United Kingdom
        • Colchester Hospital
      • London, United Kingdom
        • Kings College Hospital Denmark Hill
      • London, United Kingdom
        • University Hospital Lewisham
      • Margate, United Kingdom
        • Queen Elizabeth the Queen Mother Hospital
      • Newcastle, United Kingdom
        • Freeman Hospital
      • Newport, United Kingdom
        • Aneurin Bevan University Health Board
      • Nottingham, United Kingdom
        • Nottingham University Hospitals Nhs Trust
      • Pembury, United Kingdom
        • The Tunbridge Wells Hospital
      • Portsmouth, United Kingdom
        • Queen Alexandra
      • Preston, United Kingdom
        • Royal Preston Hospital
      • Stevenage, United Kingdom
        • Lister Hospital East and North Hertfordshire Trust
      • Stoke-on-Trent, United Kingdom
        • Royal Stoke Hospital
      • Sunderland, United Kingdom
        • Sunderland Royal Hospital
      • Torquay, United Kingdom
        • Torbay Hospital
      • Worthing, United Kingdom
        • Worthing Hospital
      • Yeovil, United Kingdom
        • Yeovil District Hospital NHS Foundation Trust
    • Hampshire
      • Southampton, Hampshire, United Kingdom
        • University Southampton NHS Trust
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85012
        • Phoenix VA Health Care System
      • Phoenix, Arizona, United States, 85006
        • Banner University Medical Center
    • California
      • Long Beach, California, United States, 90712
        • MemorialCare Long Beach Medical Center
    • Illinois
      • Evanston, Illinois, United States, 60077
        • Northshore University Healthsystem
      • Rockford, Illinois, United States, 61104
        • SwedishAmercian.Hospital
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • IU Health Methodist Hospital
    • Massachusetts
      • Burlington, Massachusetts, United States, 01805
        • Lahey Hospital and Medical Center
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • Spectrum Health
    • New Jersey
      • Marlton, New Jersey, United States, 08053
        • Virtua
      • Mount Holly, New Jersey, United States, 28012
        • Virtua
      • Voorhees, New Jersey, United States, 08043
        • Virtua
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State University Wexner Medical Center
      • Lancaster, Ohio, United States, 43130
        • Fairfield Medical Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • OU Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of the University of Pennsylvania - MICU
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • University of Tennessee Medical Center Knoxville
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center
    • Virginia
      • Charlottesville, Virginia, United States, 22901
        • University of Virginia Health System
    • Washington
      • Seattle, Washington, United States, 98104
        • Harborview Medical Center
      • Vancouver, Washington, United States, 98686
        • Legacy Salmon Creek Medical Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Froedtert Memorial Lutheran Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Usual Protein/Amino Acid Group
Patients will receive a usual protein/amino acid dose (≤1.2 g/kg/d)
Other: 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.
Active Comparator: Higher Protein/Amino Acid Group
Patients will receive a higher protein/amino acid dose (≥2.2 g/kg/d).
Other: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
60 day

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
60-day mortality
Time Frame: 60 day
Mortality 60 days post randomization
60 day

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Nutritional Adequacy
Time Frame: 60 day
To be evaluated up to 60 days post randomization
60 day
Hospital mortality
Time Frame: 60 day
To be evaluated up to 60 days post randomization
60 day
Readmission to ICU and Hospital
Time Frame: 60 day
To be evaluated up to 60 days post randomization
60 day
Duration of Mechanical Ventilation
Time Frame: 60 day
To be evaluated up to 60 days post randomization
60 day
ICU length of stay
Time Frame: 60 day
To be evaluated up to 60 days post randomization
60 day
Hospital length of stay
Time Frame: 60 day
To be evaluated up to 60 days post randomization
60 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Clinical Evaluation Research Unit at Kingston General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 21, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 3, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 3, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 17, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 17, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 19, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 28, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • The EFFORT Trial

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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