Omega-3 Fatty Acid for Critically Ill Patients.

Not Applicable

Completed

• Conditions: Sepsis
• Interventions: Drug: Placebo; Drug: Omega 3

• Registration Number: NCT03388450
• Lead Sponsor: Menoufia University

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.

Study Timeline

• Study Start: 2015-01-15
• Primary Completion: 2017-10-27
• Study Completion: 2017-11-30
• Status Verified: 2017-12
• Study First Submitted: 2017-12-24
• Study First Submitted QC: 2017-12-24
• Last Update Submitted: 2017-12-24
• Study First Posted: 2018-01-03
• Last Update Posted: 2018-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Patients received enteral nutrition supplemented without 1000 mg omega-3.
Omega 3	Omega 3	Patients received enteral nutrition supplemented with 1000 mg omega-3.

Primary Outcome Measures

Name	Time	Method
Organs dysfunction free days.	25 days during ICU stay.	The number of organs dysfunction free days (haemodynamic failure and respiratory failure free days).