Effects of Feeding Schedule on the Development of ICU Delirium

NCT ID: NCT04870554

Last Updated: 2024-11-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-26
• Study Completion Date: 2024-06-03

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.

Detailed Description

Patients will need to have at least 48 hours of enteric feedings to be included, and will be stratified by their APACHE IV score. Patients will be randomized into time restricted feeding vs continuous feeding by investigators, with no change in caloric intake nor nutrient content from orders. Patients will be assessed for delirium using the CAM-ICU (Confusion Assessment Method in the Intensive Care Unit) screening tool every twelve hours. At the time of the CAM ICU assessment, as part of the experimental design, the patient's sleep will be monitored by X8 Sleep Profiler device, placed and secured to their forehead, and the Sleep Profiler device will collect information regarding sleep quality as assessed by relative delta power, relative theta power and relative beta power.

Conditions

ICU Delirium

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Continuous Feeding

Enteric feeding will be given continuously.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Timed Feeding

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

Group Type: EXPERIMENTAL

Enteric feeding

Intervention Type: BEHAVIORAL

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

Interventions

Enteric feeding

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rutgers, The State University of New Jersey

OTHER

Sponsor Role: lead

Responsible Party

Deepali Dixit, Pharm.D., BCPS, BCCCP, FCCM

Clinical Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Deepali Dixit, PharmD

Role: PRINCIPAL_INVESTIGATOR

Rutgers Ernest Mario School of Pharmacy

Locations

Robert Wood Johnson University Hospital

New Brunswick, New Jersey, United States

Countries

United States

Other Identifiers

Pro2018001273

Identifier Type: -

Identifier Source: org_study_id