Omega-3 Fatty Acid for Critically Ill Patients.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-15

Study Completion Date

2017-11-30

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.

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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.

Conditions

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Sepsis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Omega 3

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

Group Type ACTIVE_COMPARATOR

Omega 3

Intervention Type DRUG

Enteral 1000 mg omega 3 fatty acid.

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Enteral nutrition without omega 3 fatty acid.

Interventions

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Omega 3

Enteral 1000 mg omega 3 fatty acid.

Intervention Type DRUG

Placebo

Enteral nutrition without omega 3 fatty acid.

Intervention Type DRUG

Other Intervention Names

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Omega 3 fatty acid Placebo group

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No