Higher versus standard protein targets in post-intensive care unit patients: a randomised, unblinded parallell group feasibility trial
The effect of post-intensive care unit nutrition support on recovery after critical illness.
Patients expected to be discharged from ICU within 72 hours are screened for inclusion. After obtaining informed consent, study subjects are randomised to one of the two treatment arms: - Intervention: Daily protein target of 2.0 g/kg for up to 90 days after ICU discharge. - Control: Daily protein target of 1.2 g/kg for up to 90 days after ICU discharge. The trial assignment is open label. Guidelines for energy targets are equivalent between groups. All participants will be assessed by a study dietitian to determine the optimal route and composition of feeding to achieve nutritional targets. Within 72 hours from ICU discharge, body composition will be determined by weight (kg), an ultrasonographic measurement of quadriceps muscle layer thickness (cm) and bioimpedance analysis. Medical Research Council Sum Score and grip strength by hand dynamometry will also be tested at baseline. During hospitalization, nutritional intake (oral, enteral and parenteral) will be documented daily and reviewed by the study dietitian two to three times weekly to determine the adequacy of current feeding strategies, with revised recommendations as appropriate. Biochemical markers of inflammation and renal function will be monitored at a frequency consistent with usual care on the admitting ward and documented in the eCRF. After hospital discharge, participants will receive telephone consultations with the study dietitian every 1-2 weeks to review the adequacy of protein and energy intake. Participants in the high-protein group will also receive home deliveries of high protein oral nutrition supplements corresponding to a daily intake of 0.8 g/kg. A more extensive review of home intake is performed 2-3 times during outpatient follow-up with a 3-day food diary.
1. 18 years or older 2. ICU length of stay >72 hours 3. Received invasive mechanical ventilation for 48 hours or more 4. Received enteral or parenteral nutrition during ICU stay 5. Discharged or expected to be discharged alive from ICU within 72 hours of enrollment
1. Inability to provide informed consent 2. > 72 hours between ICU discharge and enrollment 3. Inherited or acquired disorders of amino acid metabolism where high protein intake is contraindicated 4. Central nervous system injury (prior to or during hospitalisation) with impaired lower limb motor function expected to interfere with outcome assessment 5. Pre-existing cognitive impairment or language barrier expected to prevent outcome assessment or informed consent 6. Primary neuromuscular disease (e.g. myasthenia gravis, Guillanne Barré, multiple sclerosis with impaired lower limb motor function) 7. Severe lower limb arterial insufficiency expected to prevent outcome assessment 8. Lower extremity impairments (e.g. amputation, fractures, arthritis) preventing outcome assessment 9. Morbid obesity where subcutaneous adipose tissue prevents visualisation on muscle ultrasound 10. Expected dealth during hospitalisation or limitations in treatment to best supportive care 11. CAM-ICU positive on screening (patient can be screened again if delirium resolves) 12. Milk protein allergy 13. Unable to walk independently prior to acute illness resulting in ICU admission (walking aid permitted) 14. Renal insufficiency with eGFR < 45ml/min/1.73m2 15. Decompensated cirrhosis with hepatic encephalopathy 16. Treating physician at receiving ward does not consider randomisation to treatment targets to be in the best interest of the patient 17. Acute or chronic macronutrient malabsorption (i.e. high output ileostomy, intestinal failure) where the physician responsible for the patient's short or long-term care does not consider randomisation to treatment targets to be in the best interest of the patient 18. Pregnancy