Intensive Care
Conditions
Keywords
Dietitian, Nutritional recommendations, ICU nutrition
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
Interventions
OTHERDesignated dietitian for the ward
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.
Sponsors
Centre Hospitalier Universitaire de Nīmes
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Caloric deficit accumulated over 7 days | Day 7 | Caloric deficit accumulated over 7 days (kcal/kg) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average per day caloric deficit | Day 7 | Average per day caloric deficit (kcal/kg/day) |
| Caloric deficit accumulated during the ICU stay | ICU discharge (maximum of 28 days) | Caloric deficit accumulated during the ICU stay (kcal/kg) |
| Average per-day protein deficit | Day 7 | Average per-day protein deficit (grams protein/kg/day) |
| Protein deficit accumulated over 7 days | Day 7 | Protein deficit accumulated over 7 days (grams protein/kg) |
| Protein deficit accumulated during the ICU stay | ICU discharge (maximum of 28 days) | Protein deficit accumulated during the ICU stay (grams protein/kg) |
| 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 | Day 7 | daily average |
| Percentage of proteins received by enteral route | Day 7 | daily average |
| 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 | — |
| Presence/absence of on-catheter bacteremia | Day 7 | — |
| Presence/absence of ventilator acquired pneumonia | Day 7 | — |
| Presence/absence of other infections | Day 7 | — |
| Presence/absence of bed sores | Day 7 | — |
| Composite score for complications | Day 7 | Presence/absence of at least one of the following complications: on-catheter bacteremia, ventilator acquired pneumonia, other infections, bed sores |
| Minimum observed glycemia | Day 7 | — |
| Maximum observed glycemia | Day 7 | — |
| Average observed glycemia | Day 7 | — |
| Presence/absence of a glycemia measure < 0.4 g/l | Day 7 | — |
| Presence/absence of a glycemia measure > 1.8 g/l | Day 7 | — |
| Presence/absence of hypertriglyceridemia | Day 7 | — |
| 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) | — |
Contacts
PRINCIPAL_INVESTIGATORSaber Davide Barbar, MD
Centre Hospitalier Universitaire de Nīmes
STUDY_DIRECTORJean-Yves Lefrant, MD, PhD
Centre Hospitalier Universitaire de Nīmes
Outcome results
None listed