Effect of Combined IV Bolus Amino Acid Supplementation and Mobilisation on Skeletal Muscle During the First 10 Days in the ICU: A RCT (ProMob-ICU)

Stellenbosch University (SU)

Status: Completed

Conditions: Critical Illness

Treatments: Combination Product: Combined cycle ergometry and bolus amino acid supplementation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04099108

VAMI-001-IP4 (Other Grant/Funding Number)

Details and patient eligibility

About

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 (an intravenous bolus amino acid supplement combined with in-bed cycling), while the other half will receive standard of care only.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patient (≥18 years) admitted to medical/surgical ICU 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 days
• Expected ICU length of stay of 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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Intervention

Experimental group

Description:

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

Treatment:

Combination Product: Combined cycle ergometry and bolus amino acid supplementation

Control

No Intervention group

Description:

Standard of care only (standard care nutrition guided by the ESPEN 2019 guidelines, and routine mobilisation performed as per the local unit's protocols and practice)