Omega-3 Fatty Acid for Critically Ill Patients.

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Sepsis

Intervention / Treatment
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* Drug: Omega 3
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Omega 3<br>Patients received enteral nutrition supplemented with 1000 mg omega-3. | Drug: Omega 3<br>* Enteral 1000 mg omega 3 fatty acid.<br>* Other names: Omega 3 fatty acid;|
| Placebo Comparator: Placebo<br>Patients received enteral nutrition supplemented without 1000 mg omega-3. | Drug: Placebo<br>* Enteral nutrition without omega 3 fatty acid.<br>* Other names: Placebo group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Organs dysfunction free days. | The number of organs dysfunction free days (haemodynamic failure and respiratory failure free days). | 25 days during ICU stay. |