Acute muscle wasting in critically ill adults Nutritional, Metabolic, Endocrine
Conditions
Interventions
Randomisation:
Randomisation will use a 1:1 allocation ratio between arms and be stratified by site. Random permuted blocks of sizes 4 and 6 will be used within strata.
Patients will be randomised by
Sponsors
Barts Health NHS Trust
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Adults (=18 years) admitted to Critical Care who are: EITHER: • Hospitalised with acute respiratory failure (PaO2/FiO2 ratio of =39.9 KPa) AND • Expected to require advanced respiratory support (High-Flow Nasal Oxygen, non-invasive or invasive ventilation for >48 hours) AND • C-reactive Protein =75 mg/l indicating systemic inflammation AND • Nasogastric feeding planned for >48 hours OR • In multi-organ failure (Sequential Organ Failure Assessment Score [SOFA] Score =2 in two or more domains) AND • Nasogastric feeding planned for >48 hours
Exclusion criteria
Exclusion criteria: Current key exclusion criteria as of 26/06/2026: 1. Pre-existing inability to perform a sit-to-stand test (e.g., significant cognitive impairments that would impact their ability to engage in physical activity testing, Clinical Frailty score of > = 6, amputations, acute or chronic disability expected to preclude the sit-to-stand test at 30 days. amongst others) 2. New (pre-randomisation) inability to perform a sit-to-stand test. e.g., Primary neuromyopathy, acute intracerebral pathology, new or existing weight bearing restrictions or new neurological impairment amongst others) 3. Deemed unlikely to survive to 30 days OR presence of a treatment limitation 4. Contraindications to nasogastric feeding 5. Clinical need for specialist feeds 6. Patients with known inborn errors of metabolism 7. Pregnancy _____ Previous key exclusion criteria: 1. Pre-existing inability to perform a sit-to-stand test (e.g., significant cognitive impairments that would impact their ability to engage in physical activity testing, Clinical Frailty score of > = 6, amputations, acute or chronic disability expected to preclude the sit-to-stand test at 30 days. amongst others) 2. New (pre-randomisation) inability to perform a sit-to-stand test. e.g., Primary neuromyopathy, acute intracerebral pathology, new or existing weight bearing restrictions or new neurological impairment amongst others) 3. Deemed unlikely to survive to 30 days OR presence of a treatment limitation 4. Contraindications to nasogastric feeding 5. Clinical need for specialist feeds 6. Patients with known inborn errors of metabolism
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of sit-to-stand repetitions performed in 30 seconds 30 days after randomisation. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. All-cause mortality within 30 days of randomisation 2. All-cause mortality within 90 days of randomisation 3. Barthel Index at 30 days after randomisation 4. Short Form 36 quality of life questionnaire at 90 days after randomisation 5. PICUPS or PICUPS community questionnaire Index at 30 days after randomisation Safety outcome measures: 1. New (post initiation of intervention) metabolic acidosis (Base Excess of >4 mEq/l) not in keeping with the clinical condition, in the opinion of the treating clinician within 10 days of randomisation. 2. Hypoglycaemia episodes not in keeping with the clinical condition (normoglycaemia defined as 4.0-10.0 mmol/l), assessed from routine blood monitoring within 10 days from randomisation. 3. Hyperglycaemia episodes not in keeping with the clinical condition (normoglycaemia defined as 4.0-10.0 mmol/l) assessed from routine blood monitoring within 10 days from randomisation. 4. Days when an episode of diarrhoea (defined as a Bristol School Score =5) is recorded on nursing observation charts during the first 10 days from randomisation. 5. Days where an episode of vomiting is recorded on nursing observation charts during the first 10 days from randomisation. 6. Nausea defined as when an anti-emetic is given for patient-reported nausea assessed daily during the first 10 days from randomisation. Mechanistic outcome measures: 1. Daily serum urea and creatinine concentrations, for the first 10 days after randomisation. 2. Plasma metabolomic profiling at day one and day seven after randomisation. 3. Ketone body generation at day one and day seven after randomisation. | — |
Countries
England, United Kingdom
Contacts
Public ContactZudin Puthucheary
Outcome results
None listed