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

Primary Purpose

Malnutrition

Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Algorithm for enteral nutrition support
Sponsored by
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Malnutrition focused on measuring Patients with Enteral Feeding

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control group

Algorithm for enteral nutrition support

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Adequacy of enteral nutrition
The percentage of energy and proteins received by the patient trough tube feeds in contrast with the prescription

Secondary Outcome Measures

Security variable
The rate of gastrointestinal complications: diarrhea (>500cc), abdominal distention, emesis.

Full Information

First Posted
April 12, 2016
Last Updated
March 31, 2022
Sponsor
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
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1. Study Identification

Unique Protocol Identification Number
NCT02740205
Brief Title
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

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
August 13, 2020 (Actual)
Study Completion Date
August 13, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition
Keywords
Patients with Enteral Feeding

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Arm Title
Algorithm for enteral nutrition support
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Algorithm for enteral nutrition support
Other Intervention Name(s)
Protocol for enteral nutrition support
Intervention Description
Enteral nutrition support prescribed by the Clinical Nutrition Service under the instructions of the algorithm based on evidence
Primary Outcome Measure Information:
Title
Adequacy of enteral nutrition
Description
The percentage of energy and proteins received by the patient trough tube feeds in contrast with the prescription
Time Frame
4 days
Secondary Outcome Measure Information:
Title
Security variable
Description
The rate of gastrointestinal complications: diarrhea (>500cc), abdominal distention, emesis.
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aurora E Serralde-Zúñiga, MD,PhD
Organizational Affiliation
Instituto Nacional de Ciencias Medicas y Nutrición Salvador Zubirán
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
City
México
State/Province
Ciudad De México
ZIP/Postal Code
14000
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
15772383
Citation
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Efficacy and Safety of the Implementation of an Algorithm for Enteral Nutrition Support.

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