"Efficacy of Intermittent Enteral Nutrition Versus Continuous Administration in Intensive Care" (ENINCO)

May 25, 2023 updated by: Maria Dolores Saiz Vinuesa, Complejo Hospitalario Universitario de Albacete

"Efficacy of Intermittent Enteral Nutrition Versus Continuous Administration in Intensive Care Patients for the Reduction of Complications. Randomized Clinical Trial"

The goal of this clinical trial is to Determine efficacy of intermittent enteral nutrition vs continuous enteral nutrition in adults patients with a nasogastric tube in a intensive care unit.

The main question[s] it aims to answer are:

  • Reduction of gastrointestinal and respiratory complications
  • Evaluate the achievement of the caloric objective Informed consent will be requested from participants who meet the inclusion criteria.

The participants will be randomized into two groups: control group (continuous enteral nutrition) or experimental group (intermittent enteral nutrition) Researchers will compare intermittent enteral nutrition vs continuous to see if there is a reduction in gastrointestinal and respiratory complications.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

190

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 Contact

Study Contact Backup

  • Name: M.Pilar Córcoles-Jimenez, NURSE
  • Phone Number: 37169 0034967597169
  • Email: pcorcoles@sescam.org

Study Locations

  • Spain
      • Albacete, Spain, 02008
        • Recruiting
        • Maria Dolores Saiz Vinuesa
        • Contact:
        • Sub-Investigator:
          • FRANCISCA F CALERO YÁNEZ, NURSE
        • Sub-Investigator:
          • ANA MARIA AM PIQUERAS CARRIÓN, CERTIFIED NURSING ASSISTANT
        • Sub-Investigator:
          • ISABEL I MURCIA SAEZ, CRITICAL CARE PHYSICIAN
        • Sub-Investigator:
          • ELOINA E RODRIGUEZ MORENO, NURSE
        • Sub-Investigator:
          • CARMEN C CARRILERO LÓPEZ, NURSE

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients admitted to ICU of University General Hospital of Albacete
  • Need for enteral nutrition by nasogastric tube in the first 48 hours
  • Signed informed consent

Exclusion Criteria:

  • Insulin dependent diabetic patients
  • Abdominal surgery
  • Dire prognosis

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: INTERMITTENT ENTERAL NUTRITITION (IEN)
Administration of Enteral Nutriton (EN) by nasogastric tube in 4 bolus (24h): Duration of the infusion 1hour each shot, using an infusion pump.
Other: INTERMITTENT ENTERAL NUTRITITION (IEN)
Administration of Enteral Nutriton (EN) by nasogastric tube in 4 bolus (24h): Duration of the infusion 1hour each shot, using an infusion pump.
Active Comparator: CONTINUOUS ENTERAL NUTRITION (CEN)
Administration of Enteral Nutriton (EN) by nasogastric tube during 24 hours, using an infusion pump.
Other: CONTINUOS ENTERAL NUTRITITION (CEN)
Administration of Enteral Nutriton (EN) by nasogastric tube during 24 hours, using an infusion pump.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Respiratory Complications
Time Frame: during ICU stay (maximum 15 days)
Respiratory aspiration of gastric content
during ICU stay (maximum 15 days)
Gastrointestinal Complications
Time Frame: during ICU stay (maximum 15 days)
Digestive intolerance: Diarrhea, vomiting, increased gastric residual volume(GRV)
during ICU stay (maximum 15 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Achievement of the caloric objective
Time Frame: during ICU stay (up to 15 days)
Time in hours to reach caloric goal
during ICU stay (up to 15 days)
Nutritional status: MNA
Time Frame: up to two days after admission to the ICU
Measure with:Mini Nutritional Assessment,(MNA) 12-14 points: Normal nutritional status 8-11 points: risk of malnutrition 0-7 points: Malnutrition
up to two days after admission to the ICU
Changes in blood glucose
Time Frame: during ICU stay (maximum 15 days)
Episodes of hypoglycemia or hyperglycemia
during ICU stay (maximum 15 days)
ICU Stay
Time Frame: From date of randomization until 100 months
Days of stay in ICU
From date of randomization until 100 months
Mortality
Time Frame: until the date of death from any cause until 100 months
Percentage of deaths in ICU
until the date of death from any cause until 100 months
Change of type of EN administration
Time Frame: during ICU stay (maximum 15 days)
Change of EN administration modality
during ICU stay (maximum 15 days)
Nutritional status:Glim Criteria
Time Frame: up to two days after admission to the ICU

Measure with: Glim criteria: Phenotypic criteria:Non-volitional weight loss (%) Low BMI (kg/m2)Reduced muscle mass(calf circumference (cm)) Etiologic criteria: Reduced food intake or assimilation. Inflammation

*Requires at least one phenotypic criterion and one etiologic criterion for the diagnosis of malnutrition
up to two days after admission to the ICU
Nutritional status: Biochemical values
Time Frame: up to two days after admission to the ICU
Measure with:biochemical values: albumin, prealbumin, total protein
up to two days after admission to the ICU

Collaborators and Investigators

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

Sponsor

Complejo Hospitalario Universitario de Albacete

Collaborators

University of Castilla-La Mancha

Investigators

  • Principal Investigator: M.Dolores Saiz-Vinuesa, NURSE, Gerencia de Atención Integrada de Albacete

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

Helpful Links

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 (Actual)

February 10, 2022

Primary Completion (Estimated)

February 29, 2024

Study Completion (Estimated)

April 30, 2024

Study Registration Dates

First Submitted

May 3, 2023

First Submitted That Met QC Criteria

May 25, 2023

First Posted (Actual)

May 30, 2023

Study Record Updates

Last Update Posted (Actual)

May 30, 2023

Last Update Submitted That Met QC Criteria

May 25, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CHUA_59_07_2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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