Omega-3 Fatty Acid for Critically Ill Patients.
Primary Purpose
Sepsis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Omega 3
Placebo
Sponsored by
About this trial
This is an interventional other trial for Sepsis
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Omega 3
Placebo
Arm Description
Patients received enteral nutrition supplemented with 1000 mg omega-3.
Patients received enteral nutrition supplemented without 1000 mg omega-3.
Outcomes
Primary Outcome Measures
Organs dysfunction free days.
The number of organs dysfunction free days (haemodynamic failure and respiratory failure free days).
Secondary Outcome Measures
Full Information
NCT ID
NCT03388450
First Posted
December 24, 2017
Last Updated
December 24, 2017
Sponsor
Menoufia University
1. Study Identification
Unique Protocol Identification Number
NCT03388450
Brief Title
Omega-3 Fatty Acid for Critically Ill Patients.
Official Title
Effect of Enteral Nutrition With Omega-3 Fatty Acid in Critically Ill Septic Patients.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
January 15, 2015 (Actual)
Primary Completion Date
October 27, 2017 (Actual)
Study Completion Date
November 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Menoufia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Omega 3
Arm Type
Active Comparator
Arm Description
Patients received enteral nutrition supplemented with 1000 mg omega-3.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients received enteral nutrition supplemented without 1000 mg omega-3.
Intervention Type
Drug
Intervention Name(s)
Omega 3
Other Intervention Name(s)
Omega 3 fatty acid
Intervention Description
Enteral 1000 mg omega 3 fatty acid.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo group
Intervention Description
Enteral nutrition without omega 3 fatty acid.
Primary Outcome Measure Information:
Title
Organs dysfunction free days.
Description
The number of organs dysfunction free days (haemodynamic failure and respiratory failure free days).
Time Frame
25 days during ICU stay.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
12. IPD Sharing Statement
Learn more about this trial
Omega-3 Fatty Acid for Critically Ill Patients.
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