The effect of bromelain supplementation on oxidative stress, inflammatory markers and clinical outcomes in patients with traumatic brain injury admitted to the intensive care unit of Besat hospital

Determining the effect of bromelain supplementation on oxidative stress, inflammatory markers, and clinical outcomes in patients with traumatic brain injury admitted to the intensive care unit

a randomized, double-blind, placebo-controlled trial with a parallel design, phase 3, on 58 patients. A stratified block will be used for randomization.

In this study, 58 adult patients aged 18 to 65 with moderate to severe traumatic brain injury hospitalized in the intensive care unit of Besat Hospital were selected based on the inclusion criteria and randomly entered into the study groups.

Inclusion criteria: moderate to severe traumatic brain injury with GCS between 7 and 12, age range 18 to 65 years, stability of hemodynamic and metabolic status in the first 24 to 48 hours, having nutritional support through gavage, and willingness to cooperate in the study. Exclusion criteria: Having an underlying cancer disease, autoimmune diseases, congenital metabolic diseases, acute or chronic liver failure, chronic kidney failure and acute kidney failure if the patient needs dialysis, pregnancy and breastfeeding, history of known food allergy, Unwillingness to participate in the study, suffering from sepsis or any acute or chronic infection, allergy to supplements

Intervention group: People will receive 200 mg of bromelain 3 times a day for 14 days. Control group: Subjects will receive a placebo daily for 14 days.

C reactive protein; erythrocyte sedimentation rate; Malondialdehyde; Total antioxidant capacity; 28 days and 60-day mortality; Interleukin-6.

Patients are categorized and randomly assigned to the bromelain or placebo group. In order to randomly assign the patients to two groups, the classified block randomization method will be used using the website www.sealedenvelope.com. People were classified based on age (18 to 40 years and 40 to 65 years), gender (male/female) and Apache score (0 to 35 and 35 to 71) and divide into the intervention or placebo group based on blocks of four. In order to randomly allocate and based on blocks, patients who are in each of the age, gender, and APACHE II score classes, are entered into the intervention or placebo group. Randomization is concealed in sequentially numbered, sealed, opaque envelopes.

Before starting the study, all boxes containing bromelain or placebo for double-blind implementation are coded as A and B to blind the researcher and participants.