drugset / Trial / NCT02762539

Omega3 PUFA in Head Trauam

NCT02762539 ↗

Unknown 70 enrolled Mansoura University
RandomizedParallel-groupOpen-labelTreatment

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

Timeline

Start
2016-06
Primary completion
2018-01
Completion
2018-01

Drugs

EvaluationDrugModalityDoseRoute
Subject omega-3 enriched SMOF lipid emusion Unknown 0.5 g/kg Intravenous