Nocturnal Cyclic Enteral Nutrition Infusion Versus Continuous Infusion of Enteral Nutrition

Not Applicable

Withdrawn

• Conditions: Critical Illness; Enteral Feeding Intolerance; Nutrition Support
• Interventions: Other: Continuous enteral nutrition infusion; Other: Cyclic enteral nutrition infusion

• Registration Number: NCT03727165
• Lead Sponsor: Hospital Universitario San Ignacio

Brief Summary

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).

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 Timeline

• Study First Submitted: 2018-10-30
• Study First Submitted QC: 2018-10-30
• Study First Posted: 2018-11-01
• Study Start: 2018-12-11
• Status Verified: 2024-03
• Primary Completion: 2024-03-12
• Study Completion: 2024-03-12
• Last Update Submitted: 2024-03-12
• Last Update Posted: 2024-03-13

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Continuous infusion	Continuous enteral nutrition infusion	Patients with continuous infusion enteral nutrition in the intensive care unit at San Ignacio University Hospital
Cyclic infusion	Cyclic enteral nutrition infusion	Patients formulated with cyclic enteral nutrition infusion, administrated at night hours, from 4pm until 7am.

Primary Outcome Measures

Name	Time	Method
Enteral nutrition delivered/Enteral nutrition prescribed x 100	24 hours	Enteral nutrition delivered/Enteral nutrition prescribed x 100

Secondary Outcome Measures

Name	Time	Method
Enteral nutrition intolerance	24 hours	number of patients with intolerance/total number of patients

Trial Locations

Locations (1)

Hospital Universitario San Ignacio; 🇨🇴 Bogota, Bogota DC, Colombia