Effects of Feeding Schedule on the Development of ICU Delirium

Study Overview
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Brief Summary
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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 and biomarkers of circadian rhythm.

Detailed Description
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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. For the circadian rhythm marker analysis, blood samples (15 mL) will be collected at two time points: a day sample will be collected between 6 and 7 AM and a night sample will be collected between 11 PM and 12 AM. Collection will start approximately 48 hours after ICU admission. The expressions of the genes PER2 and SIRT with their proteins will be analyzed. The samples will also be used to measure serum free cortisol and serum insulin levels.

Official Title
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Effects of Feeding Schedule on the Development of ICU Delirium

Conditions
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ICU Delirium

Intervention / Treatment
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* Behavioral: Enteric feeding


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients will be randomly assigned to one of two treatment groups: standard continuous feeding or timed feeding.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Continuous Feeding<br>Enteric feeding will be given continuously. | |
| Experimental: Timed Feeding<br>Enteric feeding will be given four times per day, approximating breakfast, lunch, a snack, and dinner. | Behavioral: Enteric feeding<br>* All subjects will be given nutrition enterally, corresponding to their calculated nutritional needs.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. | 
| 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. | 
| Changes in circadian rhythm assessed using expression of PER2. | The difference between day and night expression of PER2 in serum will be compared between the two arms. | 48 hours after study enrollment. | 
| Changes in circadian rhythm assessed using expression of SIRT. | The difference between day and night expression of SIRT in serum will be compared between the two arms. | 48 hours after study enrollment. | 
| Changes in circadian rhythm assessed using cortisol. | The difference between day and night concentrations of serum free cortisol will be compared between the two arms. | At least 48 hours after study enrollment. | 
| Changes in circadian rhythm assessed using insulin. | The difference between day and night concentrations of serum insulin will be compared between the two arms. | At least 48 hours after study enrollment. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mechanical ventilation, Tube feeds