Background
Traumatic brain injury
Neuroinflammation in TBI
Nutrition support in TBI
Pycnogenol
Objectives
Main objective
Specific objectives
Trial deign
Methods/design
Patient selection
Inclusion criteria
Admission in ICU a due to TBI b | |
18 year ≤ age ≤ 65 year | |
GCS c score > 8 | |
Stable hemodynamic and metabolic status in the first 24 to 48 h | |
Having enteral nutritional support | |
Fill out the informed consent form by the patient or first-degree relatives of the patient |
Exclusion criteria
Pregnancy and lactation | |
Morbid obesity: BMI a ≥ 40 | |
Failure to start enteral nutrition in the first 24–48 h | |
Suffering from autoimmune disorders and HIV/AIDS | |
Suffering or having history of cancer and any liver failure | |
Receiving positive inotropic medications including dopamine, dobutamine, and epinephrine | |
Severe and active bleeding | |
Suffering from sepsis | |
Having a history of known food allergies |
Default criteria
Sample size
Study procedures
Randomization and masking
Intervention
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 |
Possible risk assessment of intervention
Data collection
Data management
Outcomes
Outcome | Time frame | Measurement method |
---|---|---|
Change of inflammatory markers: IL-6 a, IL-1β b | 5 and 10 days | ELISA kit |
Change of inflammatory marker: CRP c | 5 and 10 days | Auto analyzer |
Change of oxidative stress markers: MDA d, TAC e | 5 and 10 days | Calorimetry* |
Change of weight | 5 and 10 days | Portable scale “Balas” |
Change of body fat percentage | 5 and 10 days | Bio impedance device “Inbody” |
Change of body mass index | 5 and 10 days | Equation |
Change of APCHE ІІ f score | 5 and 10 days | APCHEІІ score questionnaire |
Change of SOFA g score | 3, 5, 7, 9, 10 day | SOFA score questionnaire |
Change of NUTRIC score | 5 and 10 days | NUTRIC score questionnaire |
28-day mortality | 28 days | Telephone follow-up |