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Oxepa in Multiple Trauma

NCT01099501 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2013-11-25

No results posted yet for this study

Summary

This is a single-center, prospective, randomized, comparative, double-blind controlled clinical study mend to assess the effect of enteral feeding with Oxepa (a fish oil-based nutrition), compared to an isocaloric control, on oxygenation and clinical outcomes in mechanically ventilated trauma patients.

The study population will be adults admitted to the ICU due to multiple-trauma or head trauma as a result of a gun shut, motor vehicle accidents, fall, workplace accident etc.

Conditions

  • Multiple Trauma
  • Head Trauma

Interventions

DIETARY_SUPPLEMENT

Oxepa (enteral nutrition formula, ABBOTT), at a dose determined by a patient's energy expenditure and tolerance of enteral feeding.

Oxepa will be administered(enteral nutrition formula, ABBOTT), at a dose determined by a patient's energy expenditure and tolerance of enteral feeding

DIETARY_SUPPLEMENT

oxepa

A dose determined by a patient's energy expenditure and tolerance of enteral feeding.

DIETARY_SUPPLEMENT

Control group

Pulmocare or Jevity (enteral nutrition formula, ABBOTT)will be administered at a dose determined by a patient's energy expenditure and tolerance of enteral feeding.

Sponsors & Collaborators

  • Israeli Ministry of Security

    collaborator UNKNOWN

  • Rabin Medical Center

    lead OTHER

Principal Investigators

  • Pierre Singer, MD, Professor · Rabin Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2014-05-31
Completion
2014-08-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01099501 on ClinicalTrials.gov