Omega-3 Fatty Acid for Critically Ill Patients.

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03388450
• Other study ID #: MenoufiaU2015/1ICU
• Status: Completed
• Phase: N/A
• First received: December 24, 2017
• Last updated: December 24, 2017
• Start date: January 15, 2015
• Est. completion date: November 30, 2017

Study information

• Verified date: December 2017
• Source: Menoufia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: November 30, 2017
• Est. primary completion date: October 27, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Critical Illness
• Sepsis

Intervention

Drug:
• Omega 3
Enteral 1000 mg omega 3 fatty acid.
• Placebo
Enteral nutrition without omega 3 fatty acid.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Menoufia University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Organs dysfunction free days.	The number of organs dysfunction free days (haemodynamic failure and respiratory failure free days).	25 days during ICU stay.