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Omega3 PUFA in Head Trauam

NCT ID: NCT02762539

Last Updated: 2017-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2018-01-31

Brief Summary

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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

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Conditions

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Traumatic Brain Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

omega-3 enriched SMOF lipid emusion

Intervention Type DRUG

Interventions

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omega-3 enriched SMOF lipid emusion

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* mild to moderate head trauma

Exclusion Criteria

* sensitivity to SMOF lipid severe head trauama
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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AlRefaey Kandeel

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mansoura university

Al Manşūrah, Dkahleya, Egypt

Site Status RECRUITING

Countries

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Egypt

Facility Contacts

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Alreafey Kandeel, MD

Role: primary

Other Identifiers

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Omega 3 head injury

Identifier Type: -

Identifier Source: org_study_id