The EFFORT Trial and EFFORT Outcomes Sub-study (EFFORT-Outcomes)

NCT04931940 | Unknown DMC

• 1 other identifier: The EFFORT Outcomes sub-study
• Study Type: interventional
• Target: 142
• Locations: 2 countries
• Sites: 2

Brief Summary

The investigators will evaluate the effects 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

Conditions

Critical Illness; Malnutrition

Outcome Measures

Primary Outcomes (1)

• 6-minute walk test (6MWT)

  walking distance achieved during a 6-minute walk test (6MWT) measured at hospital discharge

  Within 72 hours before discharge from the hospital

Secondary Outcomes (6)

• Quadriceps Muscle Mass

  Day 1 and Day 10 of randomization, and within 72 hours before discharge from the hospital

• Functional Status Score for ICU (FSS-ICU)

  Day 1 of randomization (surrogate interview), within 72 hours before discharge from the ICU and hospital (by trained physiotherapist)

• Handgrip strength

  Within 72 hours before discharge from the ICU and hospital

• Short Physical Performance Battery (SPPB)

  Within 72 hours before discharge from the ICU and hospital

• Quadriceps force

  Within 72 hours before discharge from the hospital

Other Outcomes (2)

• Health related quality of life by Short-Form 36 version 2 (SF-36 v2)

  6 months post-randomization

• Health-related Quality of life by Euro Quality of Life 5 Dimension 5 level (EQ-5D-5L)

  6 months post-randomization

Study Arms (2)

Usual Care

ACTIVE COMPARATOR

Patients will receive a usual protein/amino acid dose (≤1.2 g/kg/d)

Dietary Supplement: Usual Care

Higher Protein/Amino Acid Group

ACTIVE COMPARATOR

Patients will receive a higher protein/amino acid dose (≥2.2 g/kg/d).

Dietary Supplement: Higher Protein/Amino Acid Group

Interventions

Usual Care DIETARY_SUPPLEMENT

Patients will receive the usual protein dosage at ≤1.2 g/kg/day for up to 28 days in the ICU

Usual Care

Higher Protein/Amino Acid Group DIETARY_SUPPLEMENT

Patients will receive high protein dosage at ≥2.2 g/kg/day for up to 28 days in the ICU

Higher Protein/Amino Acid Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- ≥18 years old
• \- Nutritionally 'high-risk' (meeting one of the below criteria)
• Low (≤25) or High BMI (≥35)
• 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.).
• Frailty (Clinical Frailty Scale 5 or more from proxy)
• Sarcopenia- (SARC-F score of 4 or more from proxy)
• From point of screening, projected duration of mechanical ventilation \>4 days
• \- Requiring mechanical ventilation with actual or expected total duration of mechanical ventilation \>48 hours

You may not qualify if:

• \>96 continuous hours of mechanical ventilation before screening
• Expected death or withdrawal of life-sustaining treatments within 7 days from screening
• Pregnant
• The responsible clinician feels that the patient either needs low or high protein
• Patient requires parenteral nutrition only and site does not have products to reach the high protein dose group.
• Not ambulating independently prior to illness that leads to ICU admission (use of gait aid permitted)
• Lower extremity injury or impairments that prevents them from walking prior to hospital discharge (e.g. amputation, knee/hip injury)
• Pre-existing cognitive impairment or language barrier that prohibits outcomes assessment
• Pre-existing primary severe systemic neuromuscular disease resulting in severe weakness pre-ICU (e.g., Guillain Barre) 10 Intracranial or spinal process affecting motor function
• \. Patients in hospital \>5 days prior to ICU admission 12. Not expected to stay ≥4 days after enrollment

Sponsors & Collaborators

• Clinical Evaluation Research Unit at Kingston General Hospital: lead

Study Sites (2)

Gold Coast Hospital and Health Service

Gold Coast, Australia

RECRUITING

University of Malaya Medical Centre

Kuala Lumpur, 59100, Malaysia

RECRUITING

MeSH Terms

Conditions

Critical Illness; Malnutrition

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Daren K Heyland, DM

  Clinical Evaluation Research Unit

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daren K Heyland, DM

CONTACT

1 403 915-5573; dkh2@queensu.ca

Jennifer Korol, PL

CONTACT

613-549-6666; Jennifer.Korol@kingstonhsc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: May 31, 2021
• First Posted: June 18, 2021
• Study Start: December 1, 2019
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: September 1, 2021

Record last verified: 2021-08

Locations

MY (1); AU (1)