Evaluation of the Effect of Immune Modulating Enteral Nutrition Formula Versus Regular Enteral Nutrition on the Outcome of Critically Ill Sepsis Patients. A Pilot Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Sepsis
- Sponsor
- NewGiza University
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- oxygen supply
- Last Updated
- 4 years ago
Overview
Brief Summary
The aim is to compare the efficacy and tolerability of an immune modulating enteral nutrition formula versus the regular formula on the outcomes of critically ill septic patients by assessment of clinical outcomes, immune profile, tolerability and enteral nutrition intolerance and laboratory markers
Detailed Description
Nutritional formulas are considered important sources of the dietary components that the body requires. They contain the sources of fats, proteins and carbohydrates and compensate any vitamin and mineral deficiency. There is a special type of formulas called the "immune-enhancing formulas", they supplement the body not only with the energy sources but also, they boost the body's immune system as they contain multiple types of amino and fatty acids. There is an ongoing debate around the efficacy of the immune-enhancing formulas, some studies show that they make a significant difference in enhancing the clinical outcomes compared to traditional formulas while other studies showed no significant difference between the traditional formulas and immune-enhancing formula. The immune-enhancing nutritional formula is used in enteral and oral feeding for critically ill patients. It's mainly indicated in cases of malnutrition, post surgeries and traumas and immunocompromised patients. Its composition: Composition in approximate %w/w Maltodextrin 42.44% Sodium caseinate 18.25% MCT oil 6.28% Arginine 5.21% Poly-dextrose 4.00% Corn oil 3.48% Glutamine 2.61% Fish oil 2.32% Minerals 1.96% Vitamins 0.86% Artificial flavor (vanilla) This study analyzed prospectively the clinical and laboratory outcomes of critically ill sepsis patients taking regular enteral nutrition versus immune modulating formulas.
Investigators
Rana Muhammed
Principle Investigator
NewGiza University
Eligibility Criteria
Inclusion Criteria
- •Diagnosed with sepsis according to guideline criteria AND
- •Age ≥18 years
Exclusion Criteria
- •Gastrointestinal tract complications or intestinal failure or any contraindications to receive enteral nutrition
- •Hemodynamic instability on admission
Outcomes
Primary Outcomes
oxygen supply
Time Frame: 28 days
arterial blood gases
inflammatory markers
Time Frame: 28 days
C-Reactive protein
severity of disease classification
Time Frame: 28 days
acute physiology and chronic health evaluation score
immune profile
Time Frame: 28 days
C-Reactive protein
critical care need
Time Frame: 28 days
days on oxygen supply
fluid status
Time Frame: 28 days
albumin
Intensive Care Unit mortality
Time Frame: 28 days
The Sequential Organ Failure Assessment score