Omega3 PUFA in Head Trauam (SMOFbrain)

Mansoura University

Status: Unknown

Conditions: Traumatic Brain Injury

Treatments: Drug: omega-3 enriched SMOF lipid emusion

Study type: Interventional

Funder types: Other

Identifiers

NCT02762539

Omega 3 head injury

Details and patient eligibility

About

Traumatic brain injury (TBI) is major health problem that stands as a significant cause of death and permanent disability. TBI is considered as global public health epidemic. On pathophysiologic basis, TBI is described as occurring in two phases, primary and secondary. Once a primary insult occurs like trauma or ischemia, the secondary injury begins though main four mechanisms; ischemia, brain edema, axonal injury and neuro-inflammation. Omega-3 PUFAs (Polyunsaturated fatty acids) are postulated to have neuroregenerative properties with the ability to impact all four main mechanisms of the secondary injury Patients will be allocated into one of two groups through a random table generation; Control group in which patients will follow our local protocol for TBI management without SMOF-lipid infusion. SMOF-lipid group in which patients will receive 0.5 g/Kg SMOF lipid 10% emulsion (Lipid emulsion for intravenous nutrition containing; 6% soybean oil / 6% medium chain triglycerides / 5% olive oil / 3%fish oil) daily over 12 hours starting once admitted to ICU for 7 days

Enrollment: 70 estimated patients

Sex: All

Ages: 20 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• mild to moderate head trauma

Exclusion criteria

• sensitivity to SMOF lipid severe head trauama

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Control group

No Intervention group

Description:

Control group in which patients will follow our local protocol for TBI management without SMOF-lipid infusion

SMOF group

Experimental group

Description:

SMOF-lipid group in which patients will receive 0.5 g/Kg SMOF lipid 10% emulsion (Lipid emulsion for intravenous nutrition containing; 6% soybean oil / 6% medium chain triglycerides / 5% olive oil / 3%fish oil) daily over 12 hours starting once admitted to ICU for 7 days.

Treatment:

Drug: omega-3 enriched SMOF lipid emusion