Effects of Feeding Schedule on the Development of ICU Delirium

ICU Delirium Clinical Trial

Official title:

Effects of Feeding Schedule on the Development of ICU Delirium

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04870554
• Other study ID #: Pro2018001273
• Status: Recruiting
• Phase: N/A
• Start date: April 26, 2021
• Est. completion date: April 26, 2024

Study information

• Verified date: April 2024
• Source: Rutgers, The State University of New Jersey
• Contact: Deepali Dixit, PharmD
• Phone: (848) 445-6825
• Email: ddixit[@]pharmacy.rutgers.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: April 26, 2024
• Est. primary completion date: April 26, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Delirium
• ICU Delirium

Intervention

Behavioral:
• Enteric feeding
All subjects will be given nutrition enterally, corresponding to their calculated nutritional needs.

Locations

Country	Name	City	State
United States	Robert Wood Johnson University Hospital	New Brunswick	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in sleep quality assessed using delta power.	Change in relative delta power on EEG will be assessed in each arm.	Measurement will be made from study enrollment to extubation, up to 1 week.
Secondary	Change in sleep quality assessed using theta power.	Change in relative theta power on EEG will be assessed in each arm.	Measurement will be made from study enrollment to extubation, up to 1 week.
Secondary	Change in sleep quality using beta power.	Change in relative beta power on EEG will be assessed in each arm.	Measurement will be made from study enrollment to extubation, up to 1 week.