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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Intensive Care
• Intervention / Treatment: Other: Designated dietitian for the ward

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

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control intensive care wards; 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; 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; 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.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Saber Davide Barbar, MD, Centre Hospitalier Universitaire de Nīmes

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Anticipated): October 1, 2017
• Study Completion (Anticipated): April 1, 2018

Study Registration Dates

• First Submitted: December 12, 2012
• First Submitted That Met QC Criteria: December 12, 2012
• First Posted (Estimate): December 13, 2012

Study Record Updates

• Last Update Posted (Estimate): August 3, 2016
• Last Update Submitted That Met QC Criteria: August 2, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: Dietitian; Nutritional recommendations; ICU nutrition
• Other Study ID Numbers: PHRC-I/2012/SB-01; 2012-A00626-37 (Other Identifier: RCB number)