Omega3 PUFA in Head Trauam (SMOFbrain)

M

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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