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Table 3 Study schedule

From: Protein delivery in intermittent and continuous enteral nutrition with a protein-rich formula in critically ill patients—a protocol for the prospective randomized controlled proof-of-concept Protein Bolus Nutrition (Pro BoNo) study

 

Screening

Allocation

Observation time

Closeout

Time

t−1

t0

t1

t2

t3

t4

t5

t6

Day

0

1

2

3

4

5

6

7

Eligibility criteria

x

       

Informed consent

x

       

Randomisation

x

       

Baseline data

x

       

Muscle biopsy and ultrasound

x1

      

x

Start feeding

 

x2

      

Vital parameters

x

x

x

x

x

x

x

x

Primary variables

 

x

x

x

x

x

x

x

Secondary variables3

x

x

x

x

x

x

x

x

SAEs

 

x

x

x

x

x

x

x

  1. 1Performance of muscle ultrasound and biopsy on inclusion day until 3:00 pm will allow enteral feeding starting the next day at 6:00 am. Whenever the study team is not able to perform both before 3:00 pm, these study procedures will be postponed to the next day and study feeding will start the day after at 6:00 am
  2. 26:00 am
  3. 3Including laboratory parameters, documentation of side effects of enteral feeding and assessment of SOFA score