Omega3 PUFA in Head Trauam
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Staatus
Sponsorid
Mansoura University
KLIINILISES UURINGUS: NCT02762539
BioSeek: NCT02762539
Märksõnad
Abstraktne
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
Kuupäevad
| Viimati kinnitatud: | 10/31/2017 |
| Esmalt esitatud: | 05/02/2016 |
| Hinnanguline registreerumine on esitatud: | 05/02/2016 |
| Esmalt postitatud: | 05/04/2016 |
| Viimane värskendus on esitatud: | 11/24/2017 |
| Viimati värskendus postitatud: | 11/27/2017 |
| Õppe tegelik alguskuupäev: | 05/31/2016 |
| Eeldatav esmane lõpetamise kuupäev: | 12/31/2017 |
| Eeldatav uuringu lõpetamise kuupäev: | 12/31/2017 |
Seisund või haigus
Traumatic Brain Injury
Sekkumine / ravi
Drug: SMOF group
Faas
-
Käerühmad
| Arm | Sekkumine / ravi |
|---|---|
| No Intervention: Control group Control group in which patients will follow our local protocol for TBI management without SMOF-lipid infusion | |
| Experimental: SMOF group 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. | Drug: SMOF group |
Abikõlblikkuse kriteeriumid
| Õppimiseks sobivad vanused | 20 Years To 20 Years |
| Uuringuks kõlblikud sood | All |
| Võtab vastu tervislikke vabatahtlikke | Jah |
| Kriteeriumid | Inclusion Criteria: - mild to moderate head trauma Exclusion Criteria: - sensitivity to SMOF lipid severe head trauama |
Tulemus
Esmased tulemusnäitajad
1. Glasgow coma scale after 48 hour of infusion [48 hours]
