Table 3 Nine PRECIS-2 domains for trial designing characteristics
Domain | Considerations |
|---|---|
Eligibility | All eligible TBI a patients admitted directly or transferred to the ICU b of participating hospital will take PYC c along with their routine treatment |
Recruitment path | Pragmatic recruitment through usual visit of patients in ICU |
Setting | All tests and evaluation status of patients in this trials are performed routinely as a part of usual care, except specialized test including: IL-6 d, IL-1β e, MDA f, and TAC g |
Organization | ICU that has intensivist and its trained stuff |
Flexibility in delivery | PYC will be prescribed with gavage |
Flexibility in adherence | After the written consent of the patient or his/her companion, PYC will be prescribed by the intensivist and will be gavaged by the nurse. PYC is a dietary supplement and it does not interfere with other medications and will be given as part of the patient’s nutritional formula |
Follow-up | Usual follow-up that is performed for critically ill patients will be done in this trial; also, a 28-day follow-up for mortality will be performed |
Primary outcome | All outcome directly are related to clinical status of patients |
Primary analysis | Intention-to-treat with all available data will be used for analysis |