Clinical trial NCT02740205: Efficacy and Safety of the Implementation of an Algorithm for Enteral Nutrition Support.
Official title: Efficacy and Safety of the Implementation of an Algorithm for Enteral Nutrition Support Compared With Traditional Practice in Non-critical Patients: Randomized Clinical Trial, Simple Blind.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition
Keywords: Patients with Enteral Feeding
Lead sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Sponsor class: OTHER
First posted: 2016-04-15
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this trial is to evaluate the efficacy and safety of the implementation of an Algorithm for enteral nutrition support compared with usual standard practice in non-critical hospitalized patients: ASNET algorithm.

Detailed description: The algorithms for the enteral nutrition support also called protocols had been developed and implemented in the intensive care units (ICU) across the world to enhance the provision of calories and proteins via enteral nutrition (EN), increasing the proportion of patients that received an optimal amount (80-85% of their energy and protein requirements), and decreasing the caloric and protein debt. The algorithm includes different designs and interventions, the variability of the design is because the algorithm is adapted to the local necessities.

The principal reason for the algorithm implementation is the rate of underfed (receiving \<80% of prescribed of energy and protein requirements) as a result of numerous causes 26% considered avoidable events, and the variation of the clinical practice. There's a universal consensus that the EN is the principal artificial way for the macro-micro nutrients delivery, it comes with the novelty "if the gut works, use it or prepare to lose it". The evidence shows that the EN is more physiological and when the patients received the optimal amount of EN the clinical outcomes (length of hospital stay, mortality and infection rates) can decrease significantly. In average 74% of the patients in the ICU that received EN are underfed, in Mexico 71% of the hospitalized patients with EN in non-critical areas are underfed, receiving only 61% of their energy requirements during their hospitalization.

The investigators propose an algorithm for the EN support based on evidence, in order to avoid the variability in the prescription that include a prediction equation according to the BMI to calculate the energy and protein requirements. The algorithm propose the range for the initial infusion for the gastric and post-pyloric feeding in continuous infusion and evaluated the tolerability, if there is no signs and symptoms of intolerance then the infusion can be increased. If the subject present intolerability to the EN (diarrhea, abdominal distention), an action in the algorithm indicate options rather than the suspension. Moreover when the EN is interrupt for a reason that is not intolerance and only if the patient already reach the goal rate the compensatory feed table can be use it. As a part of the intervention, several educational sessions for the medical, nutritionist and nurse staff were performed during the period of the study.

The investigators hypothesize that the implementation of the algorithm for EN support will increase the amount of energy and protein safely and effectively to the patients compared with the usual practice.

The purpose of this study is to evaluate the efficacy and safety of the implementation of an algorithm for EN support (ASNET).

Eligibility criteria: Inclusion Criteria:

* Candidate to receive exclusively enteral nutrition
* Consent form signed

Exclusion Criteria:

* Patients in critical areas
* Carcinomatosis
* ICU admission
* Intestinal failure
* Receiving tube feeding prior to hospitalization

Primary outcomes:
measure: Adequacy of enteral nutrition
timeFrame: 4 days
Secondary outcomes:
measure: Security variable
timeFrame: 30 days
Other outcomes:
Locations:
city: México
country: Mexico
facility: Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
state: Ciudad De México
Study officials:
affiliation: Instituto Nacional de Ciencias Medicas y Nutrición Salvador Zubirán
name: Aurora E Serralde-Zúñiga, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
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