Omega3 PUFA in Head Trauam

NCT02762539 | Unknown DMC

• 1 other identifier: Omega 3 head injury
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Conditions

Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

• Glasgow coma scale after 48 hour of infusion

  48 hours

Study Arms (2)

Control group

NO INTERVENTION

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

SMOF group

EXPERIMENTAL

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: omega-3 enriched SMOF lipid emusion

Interventions

omega-3 enriched SMOF lipid emusion DRUG

SMOF group

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• mild to moderate head trauma

You may not qualify if:

• sensitivity to SMOF lipid severe head trauama

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura university

Al Manşūrah, Dkahleya, Egypt

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: May 3, 2016
• First Posted: May 5, 2016
• Study Start: June 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: November 28, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)