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The Effect of Higher Protein Dosing in Critically Ill Patients Ultrasound a Sub-study (EFFORTUS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04242966
Recruitment Status : Withdrawn (Study never started. Operational issues prevented study from rolling out)
First Posted : January 27, 2020
Last Update Posted : June 18, 2020
Sponsor:
Information provided by (Responsible Party):
Daren K. Heyland, Clinical Evaluation Research Unit at Kingston General Hospital

Tracking Information
First Submitted Date  ICMJE May 24, 2019
First Posted Date  ICMJE January 27, 2020
Last Update Posted Date June 18, 2020
Estimated Study Start Date  ICMJE November 1, 2020
Estimated Primary Completion Date December 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 24, 2020)
  • Change of Muscle mass of the quadriceps from baseline to day 10 post randomization [ Time Frame: at baseline (within 24 hours of randomization, day 10 days post randomization (if still in hospital) and just prior to hospital discharge. In the event that hospital discharge is prior to day 10, the day 10 measure will not be done ]
    Using ultrasound of quadriceps
  • Change of Muscle quality of the quadriceps from baseline to day 10 post randomization [ Time Frame: at baseline (within 24 hours of randomization, day 10 days post randomization (if still in hospital) and just prior to hospital discharge. In the event that hospital discharge is prior to day 10, the day 10 measure will not be done ]
    Using ultrasound of quadriceps
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Higher Protein Dosing in Critically Ill Patients Ultrasound a Sub-study
Official Title  ICMJE The Effect of Higher Protein Dosing in Critically Ill Patients: A Multicenter Registry-based Randomized Trial: The EFFORT Ultrasound a Sub-study
Brief Summary The investigators will evaluate the effects of of higher protein/amino acid dosing (≥2.2 g/kg/d) vs usual care of protein/amino acid dosing (≤1.2 g/kg/d) over muscle mass in nutritionally high risk ill patients.
Detailed Description

The EFFORT Ultrasound (US) is a sub study of the parent EFFORT trial; a multi-center, pragmatic, volunteer-driven, registry-based, randomized, clinical trial of 4000 nutritionally high-risk critically ill patients in the intensive care unit. Patients will be randomized to 1 of 2 treatment groups: a usual care 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.

Patients in the US sub-study will undergo the US measures at baseline (within 24 hours of randomization, 10 days post randomization (if still in hospital) and just prior to hospital discharge. In the event that hospital discharge is prior to day 10, the day 10 measure will not be done. To ensure standardization and quality in the measures, we have created high quality training materials and will have US films sent centrally to abstract all measurements. In the first 10 patients enrolled in the US sub-study, participating sites will conduct a run-in phase where their submitted data will be evaluated for quality and reliability (both intra and inter-rater reliability) to ensure subsequent measures are of high quality. Nutritional and clinical data for these patients will be included in the parent EFFORT trial but the US measures may be omitted if quality is poor.

The investigator has posed the following research question:

Primary Sub Study 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 the usual care prescription (≤1.2 gram/kg/day) on muscle mass and quality, and 60 day mortality?

The proposed hypothesis:

Compared to receiving the usual care 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 greater muscle mass, 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 Care
    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.
  • Other: Ultrasound measure
    Patients will undergo the ultrasound measures at baseline (within 24 hours of randomization, day 10 days post randomization (if still in hospital) and just prior to hospital discharge. In the event that hospital discharge is prior to day 10, the day 10 measure will not be done.
Study Arms  ICMJE
  • Active Comparator: Usual Care
    Patients will receive a usual protein/amino acid dose (≤1.2 g/kg/d)
    Interventions:
    • Other: Usual Care
    • Other: Ultrasound measure
  • Active Comparator: Higher Protein/Amino Acid Group
    Patients will receive a higher protein/amino acid dose (≥2.2 g/kg/d).
    Interventions:
    • Other: Higher Protein/Amino Acid Group
    • Other: Ultrasound measure
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 Withdrawn
Actual Enrollment  ICMJE
 (submitted: June 16, 2020)
0
Original Estimated Enrollment  ICMJE
 (submitted: January 24, 2020)
200
Estimated Study Completion Date  ICMJE December 1, 2022
Estimated Primary Completion Date December 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 information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04242966
Other Study ID Numbers  ICMJE The EFFORT Ultrasound
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 June 2020

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