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

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ClinicalTrials.gov Identifier: NCT03160547
Recruitment Status : Recruiting
First Posted : May 19, 2017
Last Update Posted : July 18, 2019
Sponsor:
Information provided by (Responsible Party):
Daren K. Heyland, Clinical Evaluation Research Unit at Kingston General Hospital

Tracking Information
First Submitted Date  ICMJE May 17, 2017
First Posted Date  ICMJE May 19, 2017
Last Update Posted Date July 18, 2019
Actual Study Start Date  ICMJE January 17, 2018
Estimated Primary Completion Date January 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 17, 2017)
60-day mortality [ Time Frame: 60 day ]
Mortality 60 days post randomization
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 17, 2017)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 10, 2017)
  • Nutritional Adequacy [ Time Frame: 60 day ]
    To be evaluated up to 60 days post randomization
  • Hospital mortality [ Time Frame: 60 day ]
    To be evaluated up to 60 days post randomization
  • Readmission to ICU and Hospital [ Time Frame: 60 day ]
    To be evaluated up to 60 days post randomization
  • Duration of Mechanical Ventilation [ Time Frame: 60 day ]
    To be evaluated up to 60 days post randomization
  • ICU length of stay [ Time Frame: 60 day ]
    To be evaluated up to 60 days post randomization
  • Hospital length of stay [ Time Frame: 60 day ]
    To be evaluated up to 60 days post randomization
Original Other Pre-specified Outcome Measures
 (submitted: May 17, 2017)
  • Hospital mortality [ Time Frame: 60 day ]
    To be evaluated up to 60 days post randomization
  • Duration of Mechanical Ventilation [ Time Frame: 60 day ]
    To be evaluated up to 60 days post randomization
  • ICU length of stay [ Time Frame: 60 day ]
    To be evaluated up to 60 days post randomization
  • Hospital length of stay [ Time Frame: 60 day ]
    To be evaluated up to 60 days post randomization
 
Descriptive Information
Brief Title  ICMJE The Effect of Higher Protein Dosing in Critically Ill Patients
Official Title  ICMJE The Effect of Higher Protein Dosing in Critically Ill Patients: A Multicenter Registry-based Randomized Trial
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 60 day mortality?

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 time to discharge alive from hospital?

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 improved survival and a quicker rate of recovery.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • Critical Illness
  • Malnutrition
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Active Comparator: Usual Protein/Amino Acid Group
    Patients will receive a usual protein/amino acid dose (≤1.2 g/kg/d)
    Intervention: Other: Usual Protein/Amino Acid Group
  • Active Comparator: Higher Protein/Amino Acid Group
    Patients will receive a higher protein/amino acid dose (≥2.2 g/kg/d).
    Intervention: Other: Higher Protein/Amino Acid Group
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 17, 2017)
4000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 1, 2022
Estimated Primary Completion Date January 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Daren K Heyland, MD 1 403 915-5573 dkh2@queensu.ca
Contact: Jennifer Korol, PL 613-549-6666 ext 6051 Jennifer.Korol@kingstonhsc.ca
Listed Location Countries  ICMJE Argentina,   Brazil,   Canada,   Hong Kong,   Japan,   Mexico,   Panama,   Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03160547
Other Study ID Numbers  ICMJE The EFFORT Trial
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Daren K. Heyland, Clinical Evaluation Research Unit at Kingston General Hospital
Study Sponsor  ICMJE Clinical Evaluation Research Unit at Kingston General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Daren K Heyland, MD Clinical Evaluation Research Unit
PRS Account Clinical Evaluation Research Unit at Kingston General Hospital
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP