Omega3 PUFA in Head Trauam

Not Applicable

• Conditions: Traumatic Brain Injury
• Interventions: Drug: omega-3 enriched SMOF lipid emusion

• Registration Number: NCT02762539
• Lead Sponsor: Mansoura University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-05-03
• Study First Submitted QC: 2016-05-03
• Study First Posted: 2016-05-05
• Study Start: 2016-06
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-25
• Last Update Posted: 2017-11-28
• Primary Completion: 2018-01
• Study Completion: 2018-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• mild to moderate head trauma

Exclusion Criteria

• sensitivity to SMOF lipid severe head trauama

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SMOF group	omega-3 enriched SMOF lipid emusion	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.

Primary Outcome Measures

Name	Time	Method
Glasgow coma scale after 48 hour of infusion	48 hours

Trial Locations

Locations (1)

Mansoura university; 🇪🇬 Al Manşūrah, Dkahleya, Egypt