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Omega-3 Fatty Acid for Critically Ill Patients.

M

Menoufia University

Status

Completed

Conditions

Sepsis

Treatments

Drug: Omega 3
Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT03388450
MenoufiaU2015/1ICU

Details and patient eligibility

About

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.

Full 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.

Enrollment

110 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No 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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

110 participants in 2 patient groups, including a placebo group

Omega 3
Active Comparator group
Description:
Patients received enteral nutrition supplemented with 1000 mg omega-3.
Treatment:
Drug: Omega 3
Placebo
Placebo Comparator group
Description:
Patients received enteral nutrition supplemented without 1000 mg omega-3.
Treatment:
Drug: Placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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