Inclusion and exclusion criteria for study entry
Inclusion criteria | Exclusion criteria | Rationale for exclusion |
| 1. >96 continuous hours of mechanical ventilation before enrolment | Intervention most effective delivered early85 |
2. Expected death or withdrawal of life-sustaining treatments within this hospitalisation | Patients unlikely to receive benefit | |
3. No expectation for any nutritional intake within the subsequent 72 hours | Intervention intended to occur in addition to standard clinical nutritional intake | |
4. Severe chronic liver disease (MELD score ≥20) or acute hepatic failure | Amino acid supplementation may be harmful in patients with severe liver disease | |
5. Documented allergy to the amino acid intervention | Unable to receive proposed intervention | |
6. Metabolic disorders involving impaired nitrogen utilisation | Unable to receive amino acid infusion | |
7. Not ambulating independently prior to illness that leads to ICU admission (use of gait aid permitted) | Unable to perform outcome assessments | |
8. Pre-existing primary systemic neuromuscular disease (eg, Guillain Barre) | May not benefit from proposed intervention (ie, different mechanism of muscle weakness) | |
9. Neuromuscular blocker infusion (eligible once infusion discontinued if other inclusion criteria met) | Do not meet safety criteria for cycling intervention | |
10. Intracranial or spinal process affecting motor function | May not benefit from proposed intervention (ie, different mechanism of muscle weakness) | |
11. Pre-existing cognitive impairment or language barrier that prohibits outcomes assessment | Unable to perform outcome assessments | |
12. Patients in hospital >5 days prior to ICU admission | Muscle weakness likely already established | |
13. Lower extremity impairments that prevent cycling (eg, amputation, knee/hip injury) | Unable to receive proposed cycling intervention | |
14. Remaining intubated for airway protection only | Less likely to have muscle weakness and benefit from the interventions | |
15. Weight ≥150 kg | Exceeds maximum weight permitted for use of the cycle device | |
16. Physician declines patient enrolment | Not appropriate to conduct trial | |
17. Insufficient intravenous access | Need dedicated access for nutrition intervention for several hours a day | |
18. Pregnant | Unknown effects in fetus | |
19. Incarcerated | Vulnerable population |
ICU, intensive care unit.