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OpenTrials
Completed

NCT Number: NCT03388450

Omega-3 Fatty Acid for Critically Ill Patients.

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

OMega 3

Drug

Enteral 1000 mg omega 3 fatty acid.

Other names: Omega 3 fatty acid

Placebo

Drug

Enteral nutrition without omega 3 fatty acid.

Other names: Placebo group

Primary outcomes

  1. Organs dysfunction free days.

    Time frame: 25 days during ICU stay.

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

Sponsors and collaborators

Lead sponsor

Menoufia University

Other

Registry information

Official study title

Effect of Enteral Nutrition With Omega-3 Fatty Acid in Critically Ill Septic Patients.

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jan 3, 2018
Registry last updated
Jan 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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