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

Centre Hospitalier Universitaire de Nīmes

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Conditions

Intensive Care

Interventions

Designated dietitian for the wardOTHER

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Caloric deficit accumulated over 7 days

Caloric deficit accumulated over 7 days (kcal/kg)

Time frame: Day 7

Secondary Outcomes

Average per day caloric deficit

Average per day caloric deficit (kcal/kg/day)

Time frame: Day 7

Caloric deficit accumulated during the ICU stay

Caloric deficit accumulated during the ICU stay (kcal/kg)

Time frame: ICU discharge (maximum of 28 days)

Average per-day protein deficit

Average per-day protein deficit (grams protein/kg/day)

Time frame: Day 7

Protein deficit accumulated over 7 days

Protein deficit accumulated over 7 days (grams protein/kg)

Time frame: Day 7

Protein deficit accumulated during the ICU stay

Protein deficit accumulated during the ICU stay (grams protein/kg)

Time frame: ICU discharge (maximum of 28 days)

Average per day amounts of vitamins received

Time frame: Day 7

Average per day amounts of trace elements received

Time frame: Day 7

Average per day amounts of pharmaco nutrients received

Time frame: Day 7

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Percentage of calories received by enteral route

accumulated over 7 days

Time frame: Day 7

Percentage of calories received by enteral route

accumulated over ICU stay

Time frame: ICU discharge (maximum of 28 days)

Percentage of proteins received by enteral route

daily average

Time frame: Day 7

Percentage of proteins received by enteral route

accumulated over 7 days

Time frame: Day 7

Percentage of proteins received by enteral route

accumulated over ICU stay

Time frame: ICU discharge (maximum of 28 days)

length of time spent on ventilator (hours)

Time frame: ICU discharge (maximum of 28 days)

length of ICU stay (days)

Time frame: ICU discharge (maximum of 28 days)

Number of days spent with (any) organ failure

Time frame: ICU discharge (maximum of 28 days)

Number of days on antibiotics

Time frame: ICU discharge (maximum of 28 days)

Mortality (yes/no)

Time frame: Day 90

Mortality (yes/no)

Time frame: Day 180

Presence/absence of on-catheter bacteremia

Time frame: Day 7

Presence/absence of on-catheter bacteremia

Time frame: Day 28

Presence/absence of on-catheter bacteremia

Time frame: ICU discharge (maximum of 28 days)

Presence/absence of ventilator acquired pneumonia

Time frame: Day 7

Presence/absence of ventilator acquired pneumonia

Time frame: Day 28

Presence/absence of ventilator acquired pneumonia

Time frame: ICU discharge (maximum of 28 days)

Presence/absence of other infections

Time frame: Day 7

Presence/absence of other infections

Time frame: Day 28

Presence/absence of other infections

Time frame: ICU discharge (maximum of 28 days)

Presence/absence of bed sores

Time frame: Day 7

Presence/absence of bed sores

Time frame: Day 28

Presence/absence of bed sores

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: ICU discharge (maximum of 28 days)

Minimum observed glycemia

Time frame: Day 7

Minimum observed glycemia

Time frame: ICU discharge (maximum of 28 days)

Maximum observed glycemia

Time frame: Day 7

Maximum observed glycemia

Time frame: ICU discharge (maximum of 28 days)

Average observed glycemia

Time frame: Day 7

Average observed glycemia

Time frame: ICU discharge (maximum of 28 days)

Presence/absence of a glycemia measure < 0.4 g/l

Time frame: Day 7

Presence/absence of a glycemia measure < 0.4 g/l

Time frame: ICU discharge (maximum of 28 days)

Presence/absence of a glycemia measure > 1.8 g/l

Time frame: Day 7

Presence/absence of a glycemia measure > 1.8 g/l

Time frame: ICU discharge (maximum of 28 days)

Presence/absence of hypertriglyceridemia

Time frame: Day 7

Presence/absence of hypertriglyceridemia

Time frame: ICU discharge (maximum of 28 days)

Accumulated cost of enteral nutrition

Time frame: Between Day 0 and ICU discharge (expected maximum of 28 days)

Accumulated cost of parenteral nutrition

Time frame: Between Day 0 and ICU discharge (expected maximum of 28 days)

Accumulated cost of antibiotics

Time frame: Between Day 0 and ICU discharge (expected maximum of 28 days)

Accumulated cost of sedation

Time frame: Between Day 0 and ICU discharge (expected maximum of 28 days)

Presence/absence of diarrhea

Time frame: Between Day 0 and ICU discharge (expected maximum of 28 days)

Accumulated cost of nutritional supplements

Time frame: Between Day 0 and ICU discharge (expected maximum of 28 days)

Accumulated cost of ICU stay

Time frame: Between Day 0 and ICU discharge (expected maximum of 28 days)