Clinical trial NCT04099108: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Critical Illness
Lead sponsor: University of Stellenbosch
Sponsor class: OTHER
Collaborators: name: Fresenius Kabi
First posted: 2019-09-23
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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)

Primary outcomes:
measure: Change in myofibre cross-sectional area
timeFrame: Over first week in ICU
measure: Change in muscle fibre cross-sectional area
timeFrame: Over first week in ICU
Secondary outcomes:
measure: Signalling pathways for muscle protein synthesis and breakdown
timeFrame: Over first week in ICU
measure: Change in muscle quality
timeFrame: Over first week in ICU, and if possible, upon hospital discharge or maximum day 28 of hospital stay
measure: Muscle strength
timeFrame: Performed between day 7 - 10, and repeated on day 28 of hospital stay, if possible
measure: Physical capability
timeFrame: Performed between day 7 - 10, and repeated on day 28 of hospital stay, if possible
measure: Change in protein to DNA ratio
timeFrame: Over first week in ICU
measure: Change in plasma amino acid levels
timeFrame: 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)
Other outcomes:
Locations:
city: Cape Town
country: South Africa
facility: Tygerberg Hospital
state: Western Cape
Study officials:
affiliation: University of Stellenbosch
name: Lizl Veldsman, M Nutr
role: PRINCIPAL_INVESTIGATOR
References: