Critical Illness, Sepsis
Conditions
Keywords
malnutrition, immune modulating formula
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.
Interventions
DIETARY_SUPPLEMENTNeo Mune
Neo-mune is a nutritional formula used in enteral feeding for critically ill patients. It's mainly indicated in cases of malnutrition, post surgeries and traumas and immunocompromisation. Its composition: Composition in approximate %w/w Maltodextrin 42.44% Sodium caseinate 18.25% MCT oil 6.28% Arginine 5.21% Polydextrose 4.00% Corn oil 3.48% Glutamine 2.61% Fish oil 2.32% Minerals 1.96% Vitamins 0.86% Artificial flavor (vanilla)
Sponsors
NewGiza University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intensive Care Unit mortality | 28 days | The Sequential Organ Failure Assessment score |
| severity of disease classification | 28 days | acute physiology and chronic health evaluation score |
| critical care need | 28 days | days on oxygen supply |
| inflammatory markers | 28 days | C-Reactive protein |
| immune profile | 28 days | C-Reactive protein |
| fluid status | 28 days | albumin |
| oxygen supply | 28 days | arterial blood gases |
Countries
Egypt
Contacts
Primary ContactNada Farrag, MSc
Backup ContactManal Maher, PhD
Outcome results
None listed