Nocturnal Cyclic Enteral Nutrition Infusion Versus Continuous Infusion of Enteral Nutrition

March 12, 2024 updated by: Hospital Universitario San Ignacio

Cyclic Enteral Nutrition Versus Continuous Infusion of Enteral Nutrition in Achieving Caloric Goals: Randomized Clinical Trial

Enteral nutrition is considered the best way to feed those who can´t be fed orally. the standard protocol of administration includes continuous infusion for 24 hours; nonetheless this support is constantly suspended which causes a decrease in the nutrition administered vs the one formulated.

Therefore this randomized clinical trial attempts to compare de standard administration vs. cyclic infusion during night hours measuring the formulated vs the administered volume of enteral nutrition given to the patient.

The control group will be assigned standard 24 hour infusion of enteral nutrition while the experimental group will be assigned cyclic infusion during night hours. The variables include volume formulated, volume given in 24 hours, hours and reasons why the enteral nutrition was suspended, and related complications (abdominal distension, vomiting, and diarrhea).

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

The trial will be carried at San Ignacio University Hospital intensive care unit. Patients included will be over 18 years old who require enteral nutrition according to their attending or to the nutritional and metabolic support team.

260 envelopes with the specific intervention were created. 130 of them are identified with number 0 which corresponds to no intervention, meaning continuous enteral nutrition infusion during 24 hours. The other 130 are assigned with the number 1 which corresponds to intervention, meaning nocturnal cyclic nocturnal enteral nutrition infusion.

Envelopes will be randomly assigned sequentially from number 1 to 260, in which envelope number 1 will be assigned for the first patient. Each patient´s envelope will be labeled with its name and identification number. According to the information contained in the envelope the specific scheme assigned will be formulated.

Envelopes will be kept at the Nutritional and metabolic support´s office; only research assistant will have access to this information.

After 50% of the sample be achieved, there will be a data analysis to review the rate of intolerance to enteral nutrition in both groups.

Principal investigators will review the entire data after completion of the clinical trial, measuring percentage of enteral nutrition delivered and intolerance to enteral nutrition feeding.

Study Type

Interventional

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

  • Colombia
    • Bogota DC
      • Bogota, Bogota DC, Colombia, 110111
        • Hospital Universitario San Ignacio

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

Description

Inclusion Criteria:

  • Patients over 18 years old, hospitalized in San Ignacio University Hospital intensive care unit.
  • Patients with indication on enteral nutrition defined by its attending or by the Nutritional and Metabolic support team.

Exclusion Criteria:

-If patient or legal advocate denies to sign consent to participate in this study.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Continuous infusion
Patients with continuous infusion enteral nutrition in the intensive care unit at San Ignacio University Hospital
Other: Continuous enteral nutrition infusion
Enteral nutrition administration in continuous infusion during 24 hours per day
Experimental: Cyclic infusion
Patients formulated with cyclic enteral nutrition infusion, administrated at night hours, from 4pm until 7am.
Other: Cyclic enteral nutrition infusion
Enteral nutrition administration in continuous infusion during 16 hours per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Enteral nutrition delivered/Enteral nutrition prescribed x 100
Time Frame: 24 hours
Enteral nutrition delivered/Enteral nutrition prescribed x 100
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Enteral nutrition intolerance
Time Frame: 24 hours
number of patients with intolerance/total number of patients
24 hours

Collaborators and Investigators

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

Sponsor

Hospital Universitario San Ignacio

Investigators

  • Principal Investigator: Saul J Rugeles, MD, Hospital Universitario San Ignacio

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)

December 11, 2018

Primary Completion (Actual)

March 12, 2024

Study Completion (Actual)

March 12, 2024

Study Registration Dates

First Submitted

October 30, 2018

First Submitted That Met QC Criteria

October 30, 2018

First Posted (Actual)

November 1, 2018

Study Record Updates

Last Update Posted (Actual)

March 13, 2024

Last Update Submitted That Met QC Criteria

March 12, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018/121

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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