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Trial record 8 of 25 for:    Heyland

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 : May 23, 2018
Sponsor:
Information provided by (Responsible Party):
Daren K. Heyland, Clinical Evaluation Research Unit at Kingston General Hospital

Brief Summary:
The investigator will investigate the effects of higher protein/amino acid dosing (≥2.2 g/kg/d) vs lower protein/amino acid dosing (≤1.2 g/kg/d) on clinical outcomes in nutritionally high risk ill patients.

Condition or disease Intervention/treatment Phase
Critical Illness Malnutrition Other: Lower Protein/Amino Acid Group Other: Higher Protein/Amino Acid Group Phase 3

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 lower 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 low group 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 lower 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 : Interventional  (Clinical Trial)
Estimated Enrollment : 4000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Effect of Higher Protein Dosing in Critically Ill Patients: A Multicenter Registry-based Randomized Trial
Actual Study Start Date : January 17, 2018
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : January 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Lower Protein/Amino Acid Group
Patients will receive a lower protein/amino acid dose (≤1.2 g/kg/d)
Other: Lower 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.




Primary Outcome Measures :
  1. 60-day mortality [ Time Frame: 60 day ]
    Mortality 60 days post randomization


Secondary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. Nutritional Adequacy [ Time Frame: 60 day ]
    To be evaluated up to 60 days post randomization

  2. Hospital mortality [ Time Frame: 60 day ]
    To be evaluated up to 60 days post randomization

  3. Readmission to ICU and Hospital [ Time Frame: 60 day ]
    To be evaluated up to 60 days post randomization

  4. Duration of Mechanical Ventilation [ Time Frame: 60 day ]
    To be evaluated up to 60 days post randomization

  5. ICU length of stay [ Time Frame: 60 day ]
    To be evaluated up to 60 days post randomization

  6. Hospital length of stay [ Time Frame: 60 day ]
    To be evaluated up to 60 days post randomization



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03160547


Contacts
Contact: Daren K Heyland, MD 1 403 915-5573 dkh2@queensu.ca
Contact: Janet Overvelde 613-549-6666 ext 6241 Janet.Overvelde@kingstonhsc.ca

Locations
United States, Oklahoma
OU Medical Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Karen Allen, MD       karen-allen@ouhsc.edu   
Contact: Leah Hoffman, RD       Leah-hoffman@ouhsc.edu   
United States, Pennsylvania
Hospital of the University of Pennsylvania - MICU Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Charlene Compher, PhD    215-898-3619    compherc@nursing.upenn.edu   
Principal Investigator: Charlene Compher, PhD         
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Todd Rice, MD       todd.rice@Vanderbilt.Edu   
Principal Investigator: Todd Rice, MD         
Argentina
Hospital Britanico de Buenos Aires Recruiting
Buenos Aires, Argentina, C1280AEB CABA
Contact: Sebastian Chapela, MD       spchapela@hotmail.com   
Contact: Facundo Gutierrez, MD       facundo_gutierrez@yahoo.com.ar   
Canada, Ontario
Grey Bruce Health Services Recruiting
Owen Sound, Ontario, Canada, N4K 6M9
Contact: Linda Mailhot-Hall, RD       lmailhothall@gbhs.on.ca   
Contact: Andrew Kuhl, MD       akuhl@gbhs.on.ca   
Mexico
Hospital San Javier Recruiting
Guadalajara, Jalisco, Mexico, 44670
Contact: Roberto Miranda, MD       ackerman1976@hotmail.com   
Contact: Francisco Barbosa, MD       efebeka_@hotmail.com   
Sponsors and Collaborators
Clinical Evaluation Research Unit at Kingston General Hospital
Investigators
Principal Investigator: Daren K Heyland, MD Clinical Evaluation Research Unit

Publications:

Responsible Party: Daren K. Heyland, Director, Clinical Evaluation Research Unit at Kingston General Hospital
ClinicalTrials.gov Identifier: NCT03160547     History of Changes
Other Study ID Numbers: The EFFORT Trial
First Posted: May 19, 2017    Key Record Dates
Last Update Posted: May 23, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Critical Illness
Malnutrition
Disease Attributes
Pathologic Processes
Nutrition Disorders