Clinical trial NCT01749488: The Impact of a Dietitian in the Implementation of Nutrition Recommendations During Intensive Care
Official title: The Impact of Involving a Dietitian in the Implementation of Expert Recommendations Concerning Nutrition During Intensive Care on Energy Balance
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Intensive Care
Keywords: Dietitian
Nutritional recommendations
ICU nutrition
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2012-12-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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

Eligibility criteria: 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

Primary outcomes:
measure: Caloric deficit accumulated over 7 days
timeFrame: Day 7
Secondary outcomes:
measure: Average per day caloric deficit
timeFrame: Day 7
measure: Caloric deficit accumulated during the ICU stay
timeFrame: ICU discharge (maximum of 28 days)
measure: Average per-day protein deficit
timeFrame: Day 7
measure: Protein deficit accumulated over 7 days
timeFrame: Day 7
measure: Protein deficit accumulated during the ICU stay
timeFrame: ICU discharge (maximum of 28 days)
measure: Average per day amounts of vitamins received
timeFrame: Day 7
measure: Average per day amounts of trace elements received
timeFrame: Day 7
measure: Average per day amounts of pharmaco nutrients received
timeFrame: Day 7
measure: Percentage of calories received by enteral route
timeFrame: Day 7
measure: Percentage of calories received by enteral route
timeFrame: Day 7
measure: Percentage of calories received by enteral route
timeFrame: ICU discharge (maximum of 28 days)
measure: Percentage of proteins received by enteral route
timeFrame: Day 7
measure: Percentage of proteins received by enteral route
timeFrame: Day 7
measure: Percentage of proteins received by enteral route
timeFrame: ICU discharge (maximum of 28 days)
measure: length of time spent on ventilator (hours)
timeFrame: ICU discharge (maximum of 28 days)
measure: length of ICU stay (days)
timeFrame: ICU discharge (maximum of 28 days)
measure: Number of days spent with (any) organ failure
timeFrame: ICU discharge (maximum of 28 days)
measure: Number of days on antibiotics
timeFrame: ICU discharge (maximum of 28 days)
measure: Mortality (yes/no)
timeFrame: Day 90
measure: Mortality (yes/no)
timeFrame: Day 180
measure: Presence/absence of on-catheter bacteremia
timeFrame: Day 7
measure: Presence/absence of on-catheter bacteremia
timeFrame: Day 28
measure: Presence/absence of on-catheter bacteremia
timeFrame: ICU discharge (maximum of 28 days)
measure: Presence/absence of ventilator acquired pneumonia
timeFrame: Day 7
measure: Presence/absence of ventilator acquired pneumonia
timeFrame: Day 28
measure: Presence/absence of ventilator acquired pneumonia
timeFrame: ICU discharge (maximum of 28 days)
measure: Presence/absence of other infections
timeFrame: Day 7
measure: Presence/absence of other infections
timeFrame: Day 28
measure: Presence/absence of other infections
timeFrame: ICU discharge (maximum of 28 days)
measure: Presence/absence of bed sores
timeFrame: Day 7
measure: Presence/absence of bed sores
timeFrame: Day 28
measure: Presence/absence of bed sores
timeFrame: ICU discharge (maximum of 28 days)
measure: Composite score for complications
timeFrame: Day 7
measure: Composite score for complications
timeFrame: Day 28
measure: Composite score for complications
timeFrame: ICU discharge (maximum of 28 days)
measure: Minimum observed glycemia
timeFrame: Day 7
measure: Minimum observed glycemia
timeFrame: ICU discharge (maximum of 28 days)
measure: Maximum observed glycemia
timeFrame: Day 7
measure: Maximum observed glycemia
timeFrame: ICU discharge (maximum of 28 days)
measure: Average observed glycemia
timeFrame: Day 7
measure: Average observed glycemia
timeFrame: ICU discharge (maximum of 28 days)
measure: Presence/absence of a glycemia measure < 0.4 g/l
timeFrame: Day 7
measure: Presence/absence of a glycemia measure < 0.4 g/l
timeFrame: ICU discharge (maximum of 28 days)
measure: Presence/absence of a glycemia measure > 1.8 g/l
timeFrame: Day 7
measure: Presence/absence of a glycemia measure > 1.8 g/l
timeFrame: ICU discharge (maximum of 28 days)
measure: Presence/absence of hypertriglyceridemia
timeFrame: Day 7
measure: Presence/absence of hypertriglyceridemia
timeFrame: ICU discharge (maximum of 28 days)
measure: Accumulated cost of enteral nutrition
timeFrame: Between Day 0 and ICU discharge (expected maximum of 28 days)
measure: Accumulated cost of parenteral nutrition
timeFrame: Between Day 0 and ICU discharge (expected maximum of 28 days)
measure: Accumulated cost of antibiotics
timeFrame: Between Day 0 and ICU discharge (expected maximum of 28 days)
measure: Accumulated cost of sedation
timeFrame: Between Day 0 and ICU discharge (expected maximum of 28 days)
measure: Presence/absence of diarrhea
timeFrame: Between Day 0 and ICU discharge (expected maximum of 28 days)
measure: Accumulated cost of nutritional supplements
timeFrame: Between Day 0 and ICU discharge (expected maximum of 28 days)
measure: Accumulated cost of ICU stay
timeFrame: Between Day 0 and ICU discharge (expected maximum of 28 days)
Other outcomes:
Locations:
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Saber Davide Barbar, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Jean-Yves Lefrant, MD, PhD
role: STUDY_DIRECTOR
References: