Status:
COMPLETED
Effect of Combined IV Bolus Amino Acid Supplementation and Mobilisation on Skeletal Muscle During the First 10 Days in the ICU: A RCT
Lead Sponsor:
University of Stellenbosch
Collaborating Sponsors:
Fresenius Kabi
University of the Western Cape
Conditions:
Critical Illness
Eligibility:
All Genders
18+ years
Phase:
NA
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 ch...
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 redu...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
May 24 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04099108
Start Date
May 24 2021
End Date
December 31 2022
Last Update
December 3 2025
Active Locations (1)
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1
Tygerberg Hospital
Cape Town, Western Cape, South Africa, 7505