Omega-3 Fatty Acid for Critically Ill Patients.

NCT03388450 | Completed

• 1 other identifier: MenoufiaU2015/1ICU
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Sepsis

Outcome Measures

Primary Outcomes (1)

• Organs dysfunction free days.

  The number of organs dysfunction free days (haemodynamic failure and respiratory failure free days).

  25 days during ICU stay.

Study Arms (2)

Omega 3

ACTIVE COMPARATOR

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

Drug: Omega 3

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Omega 3 DRUG

Enteral 1000 mg omega 3 fatty acid.

Also known as: Omega 3 fatty acid

Omega 3

Placebo DRUG

Enteral nutrition without omega 3 fatty acid.

Also known as: Placebo group

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All septic patients who could receive enteral nutrition were included in the study

You may not qualify if:

• 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.

Sponsors & Collaborators

• Menoufia University: lead

MeSH Terms

Conditions

Sepsis

Interventions

Docosahexaenoic Acids; Fatty Acids, Omega-3

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor in anaesthesia, intensive care, and pain medicine.

Study Record Dates

• First Submitted: December 24, 2017
• First Posted: January 3, 2018
• Study Start: January 15, 2015
• Primary Completion: October 27, 2017
• Study Completion: November 30, 2017
• Last Updated: January 3, 2018

Record last verified: 2017-12