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Omega-3 Fatty Acid for Critically Ill Patients.

Sponsor
Menoufia University (Other)
Overall Status
Completed
CT.gov ID
NCT03388450
Collaborator
(none)
110
Enrollment
2
Arms
34.5
Actual Duration (Months)

Study Details

Study Description

Brief Summary

Sepsis is the most common reason for intensive care unit (ICU) admission. Sepsis flares up the systemic inflammatory response with its mediators. Sepsis treatment protocols have been established in many centres with immune nutrient as adjuvant treatment. Omega-3 fatty acid and other anti-oxidants formulae have been found to improve sepsis outcome. In most of the studies, immune nutrients were giving parenterally, however, nowadays the preferable route of feeding in critically ill patients is enterally. The present study was done to investigate the effect of enteral Omega-3 fatty acid in septic critically ill patients.

Condition or Disease Intervention/Treatment Phase
  • Drug: Omega 3
  • Drug: Placebo
 N/A

Detailed Description

A hundred and ten critically ill septic patients were included in the study. Patients were divided into two groups fifty-five patients each. Group A received enteral nutrition supplemented with Omega-3 fatty acid and group B received enteral nutrition without Omega-3. Demographic data, sepsis characteristics, number of patients required invasive ventilation, ventilation days, ICU sequential organ failure assessment score (SOFA), organ failure free-days, haemodynamic failure free-days, ICU stay, ICU and hospital outcomes were recorded.

Study Design

Study Type:
Interventional
Actual Enrollment :
110 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Other
Official Title:
Effect of Enteral Nutrition With Omega-3 Fatty Acid in Critically Ill Septic Patients.
Actual Study Start Date :
Jan 15, 2015
Actual Primary Completion Date :
Oct 27, 2017
Actual Study Completion Date :
Nov 30, 2017

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Omega 3

Patients received enteral nutrition supplemented with 1000 mg omega-3.

Drug: Omega 3
Enteral 1000 mg omega 3 fatty acid.
Other Names:
  • Omega 3 fatty acid

    		•
    Placebo Comparator: Placebo

    Patients received enteral nutrition supplemented without 1000 mg omega-3.

    Drug: Placebo
    Enteral nutrition without omega 3 fatty acid.
    Other Names:
  • Placebo group

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Organs dysfunction free days. [25 days during ICU stay.]

      The number of organs dysfunction free days (haemodynamic failure and respiratory failure free days).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • All septic patients who could receive enteral nutrition were included in the study
    Exclusion Criteria:
    • Patients with end stage liver or renal disease, haemodynamic instability, immunosuppression, gastrointestinal comorbidity, allergic to omega-3, received omega-3 a week prior to ICU admission, patients who expected to live less than 24 hours, and patients who were mechanically ventilated on ICU admission were excluded from the study.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Menoufia University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr Ezzeldin Ibrahim, Assistant Professor in anaesthesia, intensive care, and pain medicine., Menoufia University
    ClinicalTrials.gov Identifier:
    NCT03388450
    Other Study ID Numbers:
    • MenoufiaU2015/1ICU
    First Posted:
    Jan 3, 2018
    Last Update Posted:
    Jan 3, 2018
    Last Verified:
    Dec 1, 2017
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Critical Illness

    Study Results

    No Results Posted as of Jan 3, 2018