Here is the design of a clinical trial:

Official Title: Intensive Nutrition Therapy Compared to Usual Care in Critically Ill Adults: A Randomised Pilot Trial

Included conditions:
- Critical Illness
- Critically Ill

Study Armgroups:
- {'label': 'Standard Nutrition Arm', 'type': 'NO_INTERVENTION', 'description': 'In ICU:\n\n1. After enrolment, patients allocated to the standard nutrition therapy (control) group will commence or continue nutrition via an enteral tube to a target rate according to unit protocol including the use of promotility agents and the placement of nasojejunal feeding tubes if required.\n2. PN will only be used if the above methods have been attempted, or an absolute contraindication to EN develops.\n3. Unless there is specific indication for a compounded PN solution, the PN used in the standard care group will be the same as used in the intervention arm.\n\nAfter ICU:\n\n1. Nutrition management will be as per usual site management at that hospital.\n2. Nutrition intake amounts will be recorded 3 times per week using provided study documents and assessment tools.'}
- {'label': 'Intensive Arm', 'type': 'EXPERIMENTAL', 'description': 'Intervention\n\nIn ICU:\n\n1. Supplemental PN will be commenced within 2 hours of randomisation. The starting dose of PN will be determined by the amount of energy received in the 24 hours prior to randomisation\n2. The need for the intervention will be based on the adequacy of nutrition provision from both PN and EN and assessed daily until ICU discharge\n3. If there is an actual or anticipated interruption of EN for greater than 2 hours the PN must be run at 20 kcal/kg calculated body weight until EN is recommenced. After the interruption, EN should be recommenced as per local protocol.\n\nAfter ICU:\n\nAn intensive nutrition intervention will be provided on the ward in the intervention group. This will include daily review from dedicated study dietitians and a clearly protocolized hierarchical management plan which reflects best practice clinical management.', 'interventionNames': ['Dietary Supplement: Supplemental parenteral nutrition']}

Interventions:
- {'type': 'DIETARY_SUPPLEMENT', 'name': 'Supplemental parenteral nutrition', 'description': 'Supplemental parenteral nutrition OLIMEL N12E (Baxter Healthcare Corporation)', 'armGroupLabels': ['Intensive Arm']}

Primary Outcomes:
- {'measure': 'Daily energy delivered from nutrition therapy', 'description': 'Daily energy delivered from nutrition therapy', 'timeFrame': 'Day 28'}

Please estimate the sample size based on the assumption: 
95% power with a two-sided p value of 0.05, and a potential loss to follow-up of 20%.
Sample size and power
        A recent study conducted in six ICUs in Australia and New Zealand enrolling 100 patients using a similar inclusion and exclusion criteria and coordinated by the Australian and New Zealand Intensive Care Research Centre (ANZIC-RC) found that the mean (SD) energy delivered to the standard nutrition arm throughout their hospital stay (median 22 days) was 1540 (410) kcal/day.17 Based on a minimum acceptable clinical difference of 15% (215 kcal/day), with 190 subjects, this study will have a 95% power (two-sided p value of 0.05). To account for a potential loss to follow-up of 20% due to the longitudinal nature of the study intervention, the sample size has been inflated to recruit a total of 240 participants (120 in each group). This loss to follow-up rate is based on previous work conducted by the investigators and has been observed in other studies with longitudinal follow-up.14 17 19