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Clinical Trials/NCT05186480
NCT05186480
Unknown
Not Applicable

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

NewGiza University1 site in 1 country40 target enrollmentOctober 3, 2021

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.

Registry
clinicaltrials.gov
Start Date
October 3, 2021
End Date
March 28, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

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

Study Sites (1)

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