Effects of Feeding Schedule on the Development of ICU Delirium

NCT04870554 | Terminated

• 1 other identifier: Pro2018001273
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

This study will investigate if enteric feeding schedules alter the development of delirium in Intensive Care Unit patients who have been placed on mechanical ventilation. Delirium is an altered state of consciousness, which can involve agitation, inattention, and decreased awareness. We will enroll Intensive Care Unit patients who have been placed on a ventilator and are being given tube feedings. We will randomize participants into two groups: one group will receive continuous feedings via feeding tube, and the other group will receive feedings on a schedule to mimic breakfast, lunch, a snack, and dinner. Subjects will be assessed for the development of delirium. Subjects will also be monitored for sleep quality.

Conditions

ICU Delirium

Keywords

Mechanical ventilation; Tube feeds

Outcome Measures

Primary Outcomes (1)

• Percent of patients developing delirium.

  The development of delirium as measured by the CAM-ICU (Confusion Assessment Method for the ICU) protocol. The percent of patients developing delirium will be assessed in each arm. Delirium will be assessed every 12 hours.

  48 hours after admission to the ICU.

Secondary Outcomes (3)

• Change in sleep quality assessed using delta power.

  Measurement will be made from study enrollment to extubation, up to 1 week.

• Change in sleep quality assessed using theta power.

  Measurement will be made from study enrollment to extubation, up to 1 week.

• Change in sleep quality using beta power.

  Measurement will be made from study enrollment to extubation, up to 1 week.

Study Arms (2)

Continuous Feeding

NO INTERVENTION

Enteric feeding will be given continuously.

Timed Feeding

EXPERIMENTAL

Enteric feeding will be given four times per day, approximating breakfast, lunch, a snack, and dinner.

Behavioral: Enteric feeding

Interventions

Enteric feeding BEHAVIORAL

All subjects will be given nutrition enterally, corresponding to their calculated nutritional needs.

Timed Feeding

Eligibility Criteria

• Age: 21 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Admitted to the ICU
• Mechanically ventilated
• Receiving enteric feedings for at least 48 hours

You may not qualify if:

• Pregnancy
• Previously diagnosed neurocognitive disorders,
• Alcohol withdrawal and history of alcohol dependence

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (1)

Robert Wood Johnson University Hospital

New Brunswick, New Jersey, 08901, United States

Location

Study Officials

• Deepali Dixit, PharmD

  Rutgers Ernest Mario School of Pharmacy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be under sedation. The outcome assessor for delirium (primary outcome) is not blinded. Assessors rating the sleep quality (secondary outcome) will be blinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Model Details: Patients will be randomly assigned to one of two treatment groups: standard continuous feeding or timed feeding.

Study Record Dates

• First Submitted: April 23, 2021
• First Posted: May 3, 2021
• Study Start: April 26, 2021
• Primary Completion: June 3, 2024
• Study Completion: June 3, 2024
• Last Updated: November 15, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)