The Impact of a Dietitian in the Implementation of Nutrition Recommendations During Intensive Care

Study Overview
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Brief Summary
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The main objective of this study is to evaluate the impact of the intervention of a dietician on the energy balance accumulated over seven days of intensive care. Energy balance is defined as the difference between the target recommended energy and total calorie intake actually received. This is a randomized-cluster study; participating centers are randomized into experimental and control groups.

Detailed Description
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The secondary objectives of this study are to compare the impact of the intervention of a dietician on: daily and accumulated energy balance at the end of the intensive care unit (ICU) stay deficits in protein intake per day, accumulated over 7 days, and accumulated for the ICU stay intake of vitamins, trace elements and pharmaco-nutrients per day predominant route of nutrition administration (enteral / parenteral / mixed) the course of the stay: duration of mechanical ventilation, organ failure, the ICU stay, number of days on antibiotics the presence / absence of complications: mortality, on catheter bacteremia, ventilator acquired pneumonia, other infections, bedsores, episodes of hyper-or hypoglycemia presence/absence of diarrhea costs related to the management of malnourished patients in terms of enteral and parenteral nutritional therapy, dietary supplements, antibiotics and sedatives as well as the costs of ICU stay and those related to diarrhea and sores

Official Title
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The Impact of Involving a Dietitian in the Implementation of Expert Recommendations Concerning Nutrition During Intensive Care on Energy Balance

Conditions
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Intensive Care

Intervention / Treatment
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* Other: Designated dietitian for the ward


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient must be insured or beneficiary of a health insurance plan Patients hospitalized in intensive care for an expected period greater than 72 hours, and for whom sufficient eating after 72 hours of hospitalization is deemed unlikely upon admission. Patients receiving mechanical ventilation and having at least one organ failure other than respiratory failure, defined by a SOFA score greater than 2. Exclusion Criteria: The patient is under judicial protection The patient (or his/her legal representative or trusted-person) indicates they do not wish to participate in the study It is impossible to correctly inform either the patient or his/her trusted person The patient is participating in another study, or is in an exclusion period determined by another study Moribund patients or those for whom death appears imminent (within 24 hours) Survival to Day 28 unlikely due to uncontrollable comorbidities Patients with advanced directives issued expressing the wish to not be resuscitated

Ages Eligible for Study
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Minimum Age: 18 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control intensive care wards<br>This is a randomized cluster trial. The centers randomized into this arm will serve as controls. No interventions will be implemented for these centers. | |
| Experimental: Experimental intensive care wards<br>This is a randomized cluster trial. The centers randomized into this arm will designate a dietitian who will help the ward implement current recommendations for the nutrition of patients undergoing intensive care. Intervention: Designated dietitian for the ward | Other: Designated dietitian for the ward<br>* This is a randomized cluster trial. The centers randomized into this arm will designate a dietitian who will help the ward implement current recommendations for the nutrition of patients undergoing intensive care.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Caloric deficit accumulated over 7 days | Caloric deficit accumulated over 7 days (kcal/kg) | Day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average per day caloric deficit | Average per day caloric deficit (kcal/kg/day) | Day 7 | 
| Caloric deficit accumulated during the ICU stay | Caloric deficit accumulated during the ICU stay (kcal/kg) | ICU discharge (maximum of 28 days) | 
| Average per-day protein deficit | Average per-day protein deficit (grams protein/kg/day) | Day 7 | 
| Protein deficit accumulated over 7 days | Protein deficit accumulated over 7 days (grams protein/kg) | Day 7 | 
| Protein deficit accumulated during the ICU stay | Protein deficit accumulated during the ICU stay (grams protein/kg) | ICU discharge (maximum of 28 days) | 
| Average per day amounts of vitamins received |  | Day 7 | 
| Average per day amounts of trace elements received |  | Day 7 | 
| Average per day amounts of pharmaco nutrients received |  | Day 7 | 
| Percentage of calories received by enteral route | daily average | Day 7 | 
| Percentage of calories received by enteral route | accumulated over 7 days | Day 7 | 
| Percentage of calories received by enteral route | accumulated over ICU stay | ICU discharge (maximum of 28 days) | 
| Percentage of proteins received by enteral route | daily average | Day 7 | 
| Percentage of proteins received by enteral route | accumulated over 7 days | Day 7 | 
| Percentage of proteins received by enteral route | accumulated over ICU stay | ICU discharge (maximum of 28 days) | 
| length of time spent on ventilator (hours) |  | ICU discharge (maximum of 28 days) | 
| length of ICU stay (days) |  | ICU discharge (maximum of 28 days) | 
| Number of days spent with (any) organ failure |  | ICU discharge (maximum of 28 days) | 
| Number of days on antibiotics |  | ICU discharge (maximum of 28 days) | 
| Mortality (yes/no) |  | Day 90 | 
| Mortality (yes/no) |  | Day 180 | 
| Presence/absence of on-catheter bacteremia |  | Day 7 | 
| Presence/absence of on-catheter bacteremia |  | Day 28 | 
| Presence/absence of on-catheter bacteremia |  | ICU discharge (maximum of 28 days) | 
| Presence/absence of ventilator acquired pneumonia |  | Day 7 | 
| Presence/absence of ventilator acquired pneumonia |  | Day 28 | 
| Presence/absence of ventilator acquired pneumonia |  | ICU discharge (maximum of 28 days) | 
| Presence/absence of other infections |  | Day 7 | 
| Presence/absence of other infections |  | Day 28 | 
| Presence/absence of other infections |  | ICU discharge (maximum of 28 days) | 
| Presence/absence of bed sores |  | Day 7 | 
| Presence/absence of bed sores |  | Day 28 | 
| Presence/absence of bed sores |  | ICU discharge (maximum of 28 days) | 
| Composite score for complications | Presence/absence of at least one of the following complications: on-catheter bacteremia, ventilator acquired pneumonia, other infections, bed sores | Day 7 | 
| Composite score for complications | Presence/absence of at least one of the following complications: on-catheter bacteremia, ventilator acquired pneumonia, other infections, bed sores | Day 28 | 
| Composite score for complications | Presence/absence of at least one of the following complications: on-catheter bacteremia, ventilator acquired pneumonia, other infections, bed sores | ICU discharge (maximum of 28 days) | 
| Minimum observed glycemia |  | Day 7 | 
| Minimum observed glycemia |  | ICU discharge (maximum of 28 days) | 
| Maximum observed glycemia |  | Day 7 | 
| Maximum observed glycemia |  | ICU discharge (maximum of 28 days) | 
| Average observed glycemia |  | Day 7 | 
| Average observed glycemia |  | ICU discharge (maximum of 28 days) | 
| Presence/absence of a glycemia measure < 0.4 g/l |  | Day 7 | 
| Presence/absence of a glycemia measure < 0.4 g/l |  | ICU discharge (maximum of 28 days) | 
| Presence/absence of a glycemia measure > 1.8 g/l |  | Day 7 | 
| Presence/absence of a glycemia measure > 1.8 g/l |  | ICU discharge (maximum of 28 days) | 
| Presence/absence of hypertriglyceridemia |  | Day 7 | 
| Presence/absence of hypertriglyceridemia |  | ICU discharge (maximum of 28 days) | 
| Accumulated cost of enteral nutrition |  | Between Day 0 and ICU discharge (expected maximum of 28 days) | 
| Accumulated cost of parenteral nutrition |  | Between Day 0 and ICU discharge (expected maximum of 28 days) | 
| Accumulated cost of antibiotics |  | Between Day 0 and ICU discharge (expected maximum of 28 days) | 
| Accumulated cost of sedation |  | Between Day 0 and ICU discharge (expected maximum of 28 days) | 
| Presence/absence of diarrhea |  | Between Day 0 and ICU discharge (expected maximum of 28 days) | 
| Accumulated cost of nutritional supplements |  | Between Day 0 and ICU discharge (expected maximum of 28 days) | 
| Accumulated cost of ICU stay |  | Between Day 0 and ICU discharge (expected maximum of 28 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dietitian, Nutritional recommendations, ICU nutrition