Study period | Screening | Intervention period | Evaluation | Follow-up | ||||
---|---|---|---|---|---|---|---|---|
Visit | 1 | 2 | 3 | 4 | 5 | 6 | Â | Â |
Day | 0 | 1 | 8 | 15 | 22 | 29 | * | ** |
NRS 2002 total score | x | Â | Â | Â | Â | Â | Â | Â |
NRS 2002 subscore nutritional status | x | Â | Â | Â | Â | Â | Â | Â |
Inclusion and exclusion criteria | x | Â | Â | Â | Â | Â | Â | Â |
Information, informed consent | x | Â | Â | Â | Â | Â | Â | Â |
Assignment to study group | Â | x | Â | Â | Â | Â | Â | Â |
Baseline patient characteristics | Â | x | Â | Â | Â | Â | Â | Â |
Energy intake/day (kcal)** | Â | Continuous assessment | Â | Â | ||||
Protein intake/day (g)** | Â | Â | Â | |||||
ONS intake/day (ml)** | Â | Â | Â | |||||
Serious adverse events (SAE)** | Â | Â | Â | |||||
Handgrip strength (kg) | Â | x | x*** | x*** | x*** | x*** | Â | Â |
Body weight (kg) | Â | x | x*** | x*** | x*** | x*** | Â | Â |
Body height (cm) | Â | x | Â | Â | Â | Â | Â | Â |
BMI (kg/m2) | Â | x | Â | Â | Â | Â | Â | Â |
Appetite (VAS) | Â | x | x*** | x*** | x*** | x*** | Â | Â |
Nausea (VAS) | Â | x | x*** | x*** | x*** | x*** | Â | Â |
Procedural variables | Â | Â | Â | Â | Â | Â | x | Â |
Hospital LOS (d) | Â | Â | Â | Â | Â | Â | x | Â |
30-day mortality (y/n) | Â | Â | Â | Â | Â | Â | Â | x |