Efficacy and Safety of the Implementation of an Algorithm for Enteral Nutrition Support.

March 31, 2022 updated by: Aurora Elizabeth Serralde Zúñiga, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Ciudad De México
      • México, Ciudad De México, Mexico, 14000
        • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Hospital's standard EN support at the discretion of the Clinical Nutrition Service that is composed by physicians, dietitians, and students, provides nutritional assessments, recommendations and consultations for the in-patients that required nutrition support during their hospitalization stay. There is no protocols or algorithms for the nutritional support in our institution, the currently clinical practice of the EN is prescribed by the physician, dietitians and students during the morning rounds each 24h, the kind of EN formulas prescribed depends of the clinical status of the patient, when the patients required protein supplements modular protein supplements are added.
Experimental: Algorithm for enteral nutrition support
Initial infusion of 20 to 40 ml/h, evaluated the tolerability in the next 8-12h, then the infusion can be increased 25 ml/ 8-12h for gastric infusion and 10-20 ml/h for the post-pyloric feeding, for bolus infusion an initial infusion of 125 ml each 4-5hrs and evaluated the tolerability in the next 8-12h. If the subject present intolerability to the EN, the action in the algorithm indicate hold the infusion 4h then restarted at 10 ml/h with prokinetics agents rather than the suspension. As a part of the intervention, several educational sessions for the medical, nutritionist and nurse staff were performed during the period of the study.
Other: Algorithm for enteral nutrition support
Enteral nutrition support prescribed by the Clinical Nutrition Service under the instructions of the algorithm based on evidence
Other Names:
  • Protocol for enteral nutrition support

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adequacy of enteral nutrition
Time Frame: 4 days
The percentage of energy and proteins received by the patient trough tube feeds in contrast with the prescription
4 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Security variable
Time Frame: 30 days

The rate of gastrointestinal complications:

diarrhea (>500cc), abdominal distention, emesis.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Investigators

  • Principal Investigator: Aurora E Serralde-Zúñiga, MD,PhD, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

August 13, 2020

Study Completion (Actual)

August 13, 2020

Study Registration Dates

First Submitted

April 12, 2016

First Submitted That Met QC Criteria

April 12, 2016

First Posted (Estimate)

April 15, 2016

Study Record Updates

Last Update Posted (Actual)

April 4, 2022

Last Update Submitted That Met QC Criteria

March 31, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1390

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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