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The Effect of Higher Protein Dosing in Critically Ill Patients: A Multicenter Randomized Trial (EFFORTcombo)

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ClinicalTrials.gov Identifier: NCT04012333
Recruitment Status : Not yet recruiting
First Posted : July 9, 2019
Last Update Posted : July 9, 2019
Sponsor:
Collaborator:
Clinical Evaluation Research Unit at Kingston General Hospital
Information provided by (Responsible Party):
RWTH Aachen University

Brief Summary:
The primary research question: In critically ill patients with nutrition 'risk factors', what is the effect of providing combined EN/PN to the group prescribed a higher dose (≥2.2 grams/kg/day) of protein/amino acid administration compared to a low group prescribed ≤1.2 gram/kg/day (EN only) on patient's functional recovery as measured by 6-minute walk distance just prior to hospital discharge? The hypothesis: Compared to a control group reflective of usual care prescribing practices and an EN only approach, the administration of a higher dose protein/amino acids using EN and PN to nutritionally high-risk critically ill patients will be associated with improved functional outcome.

Condition or disease Intervention/treatment Phase
Nutritional Disorder Critical Illness Malnutrition Frailty Sarcopenia Drug: OLIMEL 7,6%E / PeriOLIMEL 2,5%E Phase 3

Detailed Description:

Positive, neutral, or negative, the results of the EFFORTcombo study will inform the clinical practice in ICU settings around the world. If positive, because of the pragmatic, multicentre nature of this trial, results will be broadly applicable to all critically ill patients worldwide. If the results are negative, it will be ensured that patients no longer receive high-dose protein/amino acid admixtures or possibly, combined EN/PN.

As it relates to critical care nutrition practice in general, there is a long history of practice-changing initiatives. A process of synthesizing (in the form of evidence-based clinical practice guidelines) and disseminating best practice ideas (in the form of web-based repository of tools and information [see www.criticalcarenutrition.com]) was established.

Over the past several years, this program of research with leaders of the American Society of Parenteral and Enteral Nutrition (ASPEN) and this specific protocol at the annual Clinical Nutrition Week with society leaders, researchers, and the clinical nutrition community at large has been discussed. Partnership with ASPEN will further facilitate both, recruitment initiatives and, importantly, the knowledge translation initiatives. These efforts will increase the likelihood of the uptake of EFFORT results across the world.

This study has both the potential to answer a high-priority clinical question and also transform the new approach in clinical nutrition research. It further represents a unique collaboration between ASPEN, its global partners, and the Clinical Evaluation Research Unit, a methodological support center based in Kingston, Ontario, Canada and managed by Dr. Daren Heyland. If successful, this type of collaboration sets an important precedent for how this community may approach additional research questions related to clinical nutrition. Nested within this larger volunteer-driven registry trial, the aim is to complete a significant sub-study that will establish the role of combined EN/PN in these nutritionally high-risk patients. This protocol pertains to the specifics of this sub-study of combined EN/PN. At the end of the trial, the data from this sub-study will be merged into the results of the overall parent EFFORT Trial (where data points are similar).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 142 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Intervention: enteral and parenteral nutrition to reach protein target of 2.2g/kg/day Control: only enteral nutrition to stay below protein target of 1.2g/kg/day
Masking: Single (Outcomes Assessor)
Masking Description: Study staff performing the functional outcome measurements will be blinded to study treatment group
Primary Purpose: Prevention
Official Title: The Effect of Higher Protein Dosing in Critically Ill Patients: A Multicenter Randomized Trial
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2022

Arm Intervention/treatment
Experimental: Intervention
Patients will receive standard care plus OLIMEL 7,6%E or if no central venous access available PeriOLIMEL 2,5%E to reach protein targets: >2.2g/kg/day
Drug: OLIMEL 7,6%E / PeriOLIMEL 2,5%E
OLIMEL 7,6%E will be administered via a central access whereas PeriOLIMEL 2,5%E will be administered peripherally.

No Intervention: Standard Care
Patients will receive standard care (enteral nutrition only) to stay below the protein level: <1.2g/kg/day



Primary Outcome Measures :
  1. 6-minute walking distance [ Time Frame: at hospital discharge, up to 12 weeks ]
    measured by performing a 6-minute walking test


Secondary Outcome Measures :
  1. Overall strength-upper and lower extremity [ Time Frame: at hospital discharge, up to 12 weeks ]
    MRC sum-score

  2. Quadriceps force-lower extremity strength [ Time Frame: ICU and at hospital discharge, up to 12 weeks ]
    Hand held dynamometry

  3. Distal strength-hand grip strength [ Time Frame: ICU and at hospital discharge, up to 12 weeks ]
    Hand grip dynamometry

  4. Overall Physical Functional status [ Time Frame: Baseline (questionnaire only) and SPPB & FSS- ICU at ICU and at hospital discharge, up to 12 weeks ]
    Walking Impairment Questionnaire

  5. Overall Physical Functional status [ Time Frame: Baseline (questionnaire only) and SPPB & FSS- ICU at ICU and at hospital discharge, up to 12 weeks ]
    FSS-ICU

  6. Overall Physical Functional status [ Time Frame: Baseline (questionnaire only) and SPPB & FSS- ICU at ICU and at hospital discharge, up to 12 weeks ]
    SPPB

  7. Discharge location [ Time Frame: at hospital discharge, up to 12 weeks ]
    Discharge location

  8. Body composition [ Time Frame: Enrollment, ICU day 10 and at hospital discharge, up to 12 weeks ]
    Ultrasound of quadriceps

  9. Body composition (when clinically available) [ Time Frame: Only when clinically available, from 2 weeks before enrolment until 2 weeks after enrolment ]
    Abdominal CT scan at 3rd lumbar vertebra

  10. Health-related quality of life [ Time Frame: (Telephone) survey at baseline and 6 months ]
    SF-36

  11. Physical functioning [ Time Frame: (Telephone) survey at hospital discharge, up to 12 weeks and 6 months ]
    Katz ADL

  12. Health-related quality of life [ Time Frame: (Telephone) survey at 6 months ]
    EQ-5D-5L

  13. Physical functioning [ Time Frame: (Telephone) survey at 6 months ]
    Lawton IADL



Information from the National Library of Medicine

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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. Expected to remain mechanically ventilated for an additional 48 hours from screening;
  3. And have one or more of the following risk factors that make them at high nutritional risk:

    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

Exclusion Criteria:

  1. >96 continuous hours of mechanical ventilation before enrollment
  2. Expected death or withdrawal of life-sustaining treatments within 7 days from screening
  3. Pregnancy
  4. The responsible clinician feels that the patient either needs low or high protein
  5. Absolute contraindication to EN
  6. Severe metabolic disorders including electrolyte disorders, uncontrolled hyperglycemia, hyperlipidemia, hypophosphatemia.
  7. Severe chronic liver disease (MELD-score >20) or acute fulminant hepatitis.
  8. Metabolic disorders involving impaired nitrogen utilization
  9. Not ambulating independently prior to illness that lead to ICU admission (use of gait aid permitted)
  10. Lower extremity injury or impairments that prevents them walking prior to hospital discharge (e.g. amputation, knee/hip injury)
  11. Pre-existing cognitive impairment or language barrier that prohibits outcomes assessment
  12. Pre-existing primary severe systemic neuromuscular disease resulting in severe weakness pre-ICU (e.g., Guillain Barre)
  13. Intracranial or spinal process affecting motor function
  14. Patients in hospital >5 days prior to ICU admission

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): NCT04012333


Contacts
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Contact: Jennifer Kistermann, M.Sc. 0049241 80 35768 jkistermann@ukaachen.de
Contact: Elena Laaf, M.Sc. 0049241 80 89021 elaaf@ukaachen.de

Locations
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Germany
University Hospital RWTH Aachen Not yet recruiting
Aachen, NRW, Germany, 52074
Contact: Jennifer Kistermann, M.Sc.    0049 241 8035768    jkistermann@ukaachen.de   
Contact: Elena Laaf, M.Sc.    0049 241 8089021    elaaf@ukaachen.de   
Principal Investigator: Christian Stoppe, MD         
Sponsors and Collaborators
RWTH Aachen University
Clinical Evaluation Research Unit at Kingston General Hospital
Investigators
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Principal Investigator: Christian Stoppe, MD University Hospital RWTH Aachen

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Responsible Party: RWTH Aachen University
ClinicalTrials.gov Identifier: NCT04012333     History of Changes
Other Study ID Numbers: 18-108
First Posted: July 9, 2019    Key Record Dates
Last Update Posted: July 9, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sarcopenia
Malnutrition
Nutrition Disorders
Critical Illness
Frailty
Disease Attributes
Pathologic Processes
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms