Nocturnal Cyclic Enteral Nutrition Infusion Versus Continuous Infusion of Enteral Nutrition

NCT03727165 | Withdrawn DMC

• 1 other identifier: 2018/121
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Critical Illness; Enteral Feeding Intolerance; Nutrition Support

Keywords

enteral nutrition; critically ill; continous infusion; cyclic infusion

Outcome Measures

Primary Outcomes (1)

• Enteral nutrition delivered/Enteral nutrition prescribed x 100

  Enteral nutrition delivered/Enteral nutrition prescribed x 100

  24 hours

Secondary Outcomes (1)

• Enteral nutrition intolerance

  24 hours

Study Arms (2)

Continuous infusion

ACTIVE COMPARATOR

Patients with continuous infusion enteral nutrition in the intensive care unit at San Ignacio University Hospital

Other: Continuous enteral nutrition infusion

Cyclic infusion

EXPERIMENTAL

Patients formulated with cyclic enteral nutrition infusion, administrated at night hours, from 4pm until 7am.

Other: Cyclic enteral nutrition infusion

Interventions

Continuous enteral nutrition infusion OTHER

Enteral nutrition administration in continuous infusion during 24 hours per day

Continuous infusion

Cyclic enteral nutrition infusion OTHER

Enteral nutrition administration in continuous infusion during 16 hours per day

Cyclic infusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Hospital Universitario San Ignacio: lead

Study Sites (1)

Hospital Universitario San Ignacio

Bogotá, Bogota DC, 110111, Colombia

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Saul J Rugeles, MD

  Hospital Universitario San Ignacio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participants will be in the intensive care unit under sedative treatment and will not know about randomization Nurses in the intensive care unit (care providers of enteral nutrition infusion) will not know about the study Outcomes evaluation will be made by one independent clinical epidemiologist
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized clinical trial

Study Record Dates

• First Submitted: October 30, 2018
• First Posted: November 1, 2018
• Study Start: December 11, 2018
• Primary Completion: March 12, 2024
• Study Completion: March 12, 2024
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)