Critical Illness, Enteral Nutrition Therapy, TBI Traumatic Brain Injury
Conditions
Keywords
Trauma brain injury, Enteral nutrition, Critically ill, Muscle Loss
Brief summary
This randomized controlled clinical trial aims to determine whether there are differences in muscle mass (MM) in patients with traumatic brain injury who receive enteral nutrition based on polymeric formulas (homemade formula with blended natural foods versus commercial formulas).
Detailed description
Patients admitted to the intensive care unit (ICU) with traumatic brain injury (TBI) lose MM, especially during the first ten days because it's used for organic, immune and tissue repair functions; the patients with moderate or severe TBI are frequently unable to eat food by themselves, so they receive enteral nutrition support (NS) with polymeric formulas. This support has been shown to attenuate muscle loss. Polymeric formulas can be industrially formulated or made with natural food, but there is no information available on their effect on MM using indicators such as femoral muscle thickness (femoral thickness, rectus femoris and vastus intermedius) by ultrasound (US) and phase angle (PhA) obtained by bioimpedance (BIA), as well as gastrointestinal tolerance (GIT).
Interventions
OTHERHomemade formula
Patients will receive enteral feeding with a polymeric formula made from blended natural foods (apple, chayote, cookie, chicken and olive oil), adjusted to meet their nutritional requirements (energy: 25 kcal/kg, protein: 1.3 g/kg).
DIETARY_SUPPLEMENTCommercial formula
Patients will receive enteral feeding with a commercial polymeric formula, adjusted to meet their nutritional requirements (energy: 25 kcal/kg, protein: 1.3 g/kg).
Sponsors
Hospital General Dr. Miguel Silva de Morelia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Masking description
Both the patient and the principal investigator will be blinded to the assigned formula. A hospital nutritionist will be responsible for the prescription and progression according to the proposed requirements and the tolerance of the assigned formula.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age: ≥ 18 years - 65 years * Sex: Both sexes * Moderate/severe TBI (Glasgow \<13 points) admitted to the ICU * Invasive mechanical ventilation \>48 hours * Candidates for enteral nutrition via nasogastric/orogastric tube
Exclusion criteria
* Pregnant women * Patients with pacemakers * Food allergies: egg, chicken, fish, nuts, or lactose intolerance * Brain death * Limb amputation or presence of external limb fixators Elimination criteria: * Withdrawal of consent * Transfer to another healthcare institution.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Femoral muscle (total femoral thickness, rectus femoris vastus intermedius) ultrasound | Change from baseline to end of study, an average of 10 days, with three measurements during follow-up (baseline, 5 days, and 10 days) | Ultrasound-guided assessment of femoral muscle thickness. A certified intensivist physician accredited by the World Interactive Network Focused On Critical UltraSound, will perform duplicate measurements of muscle thicknesses (total femoral thickness, rectus femoris, and vastus intermedius) at the midpoint and one-third point of the distance between the superior border of the patella and the anterior superior iliac spine. The linear transducer will be positioned at a 90° angle to the thigh, without applying pressure (no compression). The average of the four measurements will then be calculated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Phase angle | Change from baseline to end of study, an average of 10 days, with three measurements during follow-up (baseline, 5 days, and 10 days) | PhA was assessed using a multifrequency BIA analyzer with 8 limb electrodes, two electrodes per limb. Measurements were taken either two hours before or two hours after the formula infusion. |
Countries
Mexico
Outcome results
None listed