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Omega-3 Fatty Acid for Critically Ill Patients.

Primary Purpose

Sepsis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Omega 3
Placebo
Sponsored by
Menoufia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Sepsis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Omega 3

    Placebo

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    December 24, 2017
    Last Updated
    December 24, 2017
    Sponsor
    Menoufia University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03388450
    Brief Title
    Omega-3 Fatty Acid for Critically Ill Patients.
    Official Title
    Effect of Enteral Nutrition With Omega-3 Fatty Acid in Critically Ill Septic Patients.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    January 15, 2015 (Actual)
    Primary Completion Date
    October 27, 2017 (Actual)
    Study Completion Date
    November 30, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Menoufia University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sepsis

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    110 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Omega 3
    Arm Type
    Active Comparator
    Arm Description
    Patients received enteral nutrition supplemented with 1000 mg omega-3.
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Patients received enteral nutrition supplemented without 1000 mg omega-3.
    Intervention Type
    Drug
    Intervention Name(s)
    Omega 3
    Other Intervention Name(s)
    Omega 3 fatty acid
    Intervention Description
    Enteral 1000 mg omega 3 fatty acid.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Other Intervention Name(s)
    Placebo group
    Intervention Description
    Enteral nutrition without omega 3 fatty acid.
    Primary Outcome Measure Information:
    Title
    Organs dysfunction free days.
    Description
    The number of organs dysfunction free days (haemodynamic failure and respiratory failure free days).
    Time Frame
    25 days during ICU stay.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

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    Omega-3 Fatty Acid for Critically Ill Patients.

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