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Effect of Combined IV Bolus Amino Acid Supplementation and Mobilisation on Muscle Mass in Patients Over the First Week of ICU Care: RCT

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04099108
Recruitment Status : Not yet recruiting
First Posted : September 23, 2019
Last Update Posted : September 30, 2019
Sponsor:
Collaborator:
Fresenius Kabi
Information provided by (Responsible Party):
Prof Renee Blaauw, University of Stellenbosch

Brief Summary:
A single-centre, two-arm, parallel randomised controlled trial (RCT) to compare the combined effect of early intravenous bolus amino acid supplementation and mobilisation versus standard of care on changes in muscle mass over the first week in ICU. Half of study participants will receive the study intervention (in-bed cycling followed by an intravenous bolus amino acid supplement), while the other half will receive standard of care only.

Condition or disease Intervention/treatment Phase
Critical Illness Combination Product: Combined cycle ergometry and bolus amino acid supplementation Not Applicable

Detailed Description:
Critical illness survivors often suffer from severe muscle mass depletion and a profound long-term functional impairment. Hence effective strategies, or a combination of strategies, are needed to reduce skeletal muscle wasting during critical illness. Although amino acids and mobilisation are both known to stimulate the mechanistic target of rapamycin pathway (MTOR) pathway for muscle protein synthesis in healthy adults, there are no trials to date investigating the combined approach of combined cycle ergometry and bolus amino acid supplementation on muscle accretion in the ICU.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: The Effect of Combined Intravenous Bolus Amino Acid Supplementation and Mobilisation on Muscle Mass in Critically Ill Patients Over the First Week of ICU Care: a Randomised Controlled Trial.
Estimated Study Start Date : July 1, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
Combined cycle ergometry and bolus amino acid supplementation, along with standard of care
Combination Product: Combined cycle ergometry and bolus amino acid supplementation
A 4-hour bolus amino acid supplement administered within 30 minutes after a 30-minute in-bed cycling session.

No Intervention: Control
Standard of care only



Primary Outcome Measures :
  1. Change in myofibre cross-sectional area [ Time Frame: Over first week in ICU ]
    Obtained from muscle biopsy of the musculus vastus lateralis of the quadriceps

  2. Change in muscle fibre cross-sectional area [ Time Frame: Over first week in ICU ]
    Bases on ultrasound of the quadriceps femoris muscle


Secondary Outcome Measures :
  1. Signalling pathways for muscle protein synthesis and breakdown [ Time Frame: Over first week in ICU ]
    Key proteins regulating muscle protein synthesis and breakdown, including markers of autophagy

  2. Change in muscle quality [ Time Frame: Over first week in ICU, and if possible, upon hospital discharge or maximum day 28 of hospital stay ]
    Muscle echogenicity from ultrasound of quadriceps femoris muscle and phase angle obtained from bio-electrical impedance

  3. Muscle strength [ Time Frame: Performed between day 7 - 10, and repeated on day 28 of hospital stay, if possible ]
    Overall muscle strength will be evaluated using the Medical Research Council (MRC) sum-score via standardised "manual muscle testing" with each of 12 muscle groups assessed using a 6-point MRC scale and summed to a total score (range: 0 - 60)

  4. Physical capability [ Time Frame: Performed between day 7 - 10, and repeated on day 28 of hospital stay, if possible ]
    Based on 6-minute walking test

  5. Change in protein to DNA ratio [ Time Frame: Over first week in ICU ]
    Obtained from muscle biopsy of the musculus vastus lateralis of the quadriceps

  6. Change in plasma amino acid levels [ Time Frame: Blood samples will be obtained at 3 time intervals, (1) prior to amino acid infusion (T0), (2) 4 hours post amino acid infusion (T1), and (3) 24 hours post amino acid infusion (T2) ]
    Based on blood samples obtained on ICU day 5



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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:

  • Adult patient (≥18 years) admitted to medical/surgical ICUs of Tygerberg Academic Hospital (TBH)
  • Expected length of mechanical- or non-invasive ventilation > 48 hours
  • Receiving enteral (EN) and/or parenteral nutrition (PN) as per standard care and for a minimum of 5 - 7 days
  • Expected ICU length of stay of 5 - 7 days

Exclusion Criteria:

  • Spinal cord lesion or intracranial process associated with muscle weakness
  • Acute/chronic degenerative neuromuscular condition
  • Fulminant hepatic failure/severe chronic liver disease (MELD score ≥20) or renal failure (based on KDIGO) not on Renal Replacement Therapy
  • Untreated thrombosis, or thrombosis where therapeutic levels of anticoagulants have not been reached at the time of inclusion
  • Any condition deemed inappropriate by the overseeing doctor- such as precautions or contraindications related to the movement as a result of trauma and/or surgery to the spine, pelvis or lower limbs, or haemodynamic instability.
  • Other: imminent death or withdrawal of treatment, pregnancy, lower limb amputation/s or fractures, readmission after previous randomisation, long-term corticosteroid therapy, morbidly obese (BMI ≥ 40kg/m2)

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): NCT04099108


Contacts
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Contact: Lizl Veldsman 27795202568 rb@sun.ac.za
Contact: Renee Blaauw, PhD 27832250277 rb@sun.ac.za

Sponsors and Collaborators
University of Stellenbosch
Fresenius Kabi
Investigators
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Principal Investigator: Lizl Veldsman, M Nutr University of Stellenbosch

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Responsible Party: Prof Renee Blaauw, Professor, University of Stellenbosch
ClinicalTrials.gov Identifier: NCT04099108    
Other Study ID Numbers: 001
First Posted: September 23, 2019    Key Record Dates
Last Update Posted: September 30, 2019
Last Verified: September 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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Critical Illness
Disease Attributes
Pathologic Processes