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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

Primary Purpose

Critical Illness

Status
Recruiting
Phase
Not Applicable
Locations
South Africa
Study Type
Interventional
Intervention
Combined cycle ergometry and bolus amino acid supplementation
Sponsored by
University of Stellenbosch
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Critical Illness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Tygerberg HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

Combined cycle ergometry and bolus amino acid supplementation, along with standard of care

Standard of care only

Outcomes

Primary Outcome Measures

Change in myofibre cross-sectional area
Obtained from muscle biopsy of the musculus vastus lateralis of the quadriceps
Change in muscle fibre cross-sectional area
Bases on ultrasound of the quadriceps femoris muscle

Secondary Outcome Measures

Signalling pathways for muscle protein synthesis and breakdown
Key proteins regulating muscle protein synthesis and breakdown, including markers of autophagy
Change in muscle quality
Muscle echogenicity from ultrasound of quadriceps femoris muscle and phase angle obtained from bio-electrical impedance
Muscle strength
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)
Physical capability
Based on 6-minute walking test
Change in protein to DNA ratio
Obtained from muscle biopsy of the musculus vastus lateralis of the quadriceps
Change in plasma amino acid levels
Based on blood samples obtained on ICU day 5

Full Information

First Posted
September 18, 2019
Last Updated
January 12, 2022
Sponsor
University of Stellenbosch
Collaborators
Fresenius Kabi
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1. Study Identification

Unique Protocol Identification Number
NCT04099108
Brief Title
Effect of Combined IV Bolus Amino Acid Supplementation and Mobilisation on Muscle Mass in Patients Over the First Week of ICU Care: RCT
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.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 26, 2021 (Actual)
Primary Completion Date
August 30, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Stellenbosch
Collaborators
Fresenius Kabi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Combined cycle ergometry and bolus amino acid supplementation, along with standard of care
Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard of care only
Intervention Type
Combination Product
Intervention Name(s)
Combined cycle ergometry and bolus amino acid supplementation
Intervention Description
A 4-hour bolus amino acid supplement administered within 30 minutes after a 30-minute in-bed cycling session.
Primary Outcome Measure Information:
Title
Change in myofibre cross-sectional area
Description
Obtained from muscle biopsy of the musculus vastus lateralis of the quadriceps
Time Frame
Over first week in ICU
Title
Change in muscle fibre cross-sectional area
Description
Bases on ultrasound of the quadriceps femoris muscle
Time Frame
Over first week in ICU
Secondary Outcome Measure Information:
Title
Signalling pathways for muscle protein synthesis and breakdown
Description
Key proteins regulating muscle protein synthesis and breakdown, including markers of autophagy
Time Frame
Over first week in ICU
Title
Change in muscle quality
Description
Muscle echogenicity from ultrasound of quadriceps femoris muscle and phase angle obtained from bio-electrical impedance
Time Frame
Over first week in ICU, and if possible, upon hospital discharge or maximum day 28 of hospital stay
Title
Muscle strength
Description
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)
Time Frame
Performed between day 7 - 10, and repeated on day 28 of hospital stay, if possible
Title
Physical capability
Description
Based on 6-minute walking test
Time Frame
Performed between day 7 - 10, and repeated on day 28 of hospital stay, if possible
Title
Change in protein to DNA ratio
Description
Obtained from muscle biopsy of the musculus vastus lateralis of the quadriceps
Time Frame
Over first week in ICU
Title
Change in plasma amino acid levels
Description
Based on blood samples obtained on ICU day 5
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lizl Veldsman
Phone
27795202568
Email
rb@sun.ac.za
First Name & Middle Initial & Last Name or Official Title & Degree
Renee Blaauw, PhD
Phone
27832250277
Email
rb@sun.ac.za
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lizl Veldsman, M Nutr
Organizational Affiliation
University of Stellenbosch
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tygerberg Hospital
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7505
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Renee Blaauw, PhD
Phone
+27 21 9389690
Email
rb@sun.ac.za

12. IPD Sharing Statement

Plan to Share IPD
No

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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

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