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

This study has been withdrawn prior to enrollment.
(The intervention becomes obsolete for participating centres pending regulatories.)
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01749488
First received: December 12, 2012
Last updated: August 2, 2016
Last verified: August 2016
  Purpose

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.


Condition Intervention
Intensive Care
Other: Designated dietitian for the ward

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Impact of Involving a Dietitian in the Implementation of Expert Recommendations Concerning Nutrition During Intensive Care on Energy Balance

Further study details as provided by Centre Hospitalier Universitaire de Nīmes:

Primary Outcome Measures:
  • Caloric deficit accumulated over 7 days [ Time Frame: Day 7 ]
    Caloric deficit accumulated over 7 days (kcal/kg)


Secondary Outcome Measures:
  • Average per day caloric deficit [ Time Frame: Day 7 ]
    Average per day caloric deficit (kcal/kg/day)

  • Caloric deficit accumulated during the ICU stay [ Time Frame: ICU discharge (maximum of 28 days) ]
    Caloric deficit accumulated during the ICU stay (kcal/kg)

  • Average per-day protein deficit [ Time Frame: Day 7 ]
    Average per-day protein deficit (grams protein/kg/day)

  • Protein deficit accumulated over 7 days [ Time Frame: Day 7 ]
    Protein deficit accumulated over 7 days (grams protein/kg)

  • Protein deficit accumulated during the ICU stay [ Time Frame: ICU discharge (maximum of 28 days) ]
    Protein deficit accumulated during the ICU stay (grams protein/kg)

  • 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 ]
  • Percentage of calories received by enteral route [ Time Frame: Day 7 ]
    daily average

  • Percentage of calories received by enteral route [ Time Frame: Day 7 ]
    accumulated over 7 days

  • Percentage of calories received by enteral route [ Time Frame: ICU discharge (maximum of 28 days) ]
    accumulated over ICU stay

  • Percentage of proteins received by enteral route [ Time Frame: Day 7 ]
    daily average

  • Percentage of proteins received by enteral route [ Time Frame: Day 7 ]
    accumulated over 7 days

  • Percentage of proteins received by enteral route [ Time Frame: ICU discharge (maximum of 28 days) ]
    accumulated over ICU stay

  • 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 [ Time Frame: Day 7 ]
    Presence/absence of at least one of the following complications: on-catheter bacteremia, ventilator acquired pneumonia, other infections, bed sores

  • Composite score for complications [ Time Frame: Day 28 ]
    Presence/absence of at least one of the following complications: on-catheter bacteremia, ventilator acquired pneumonia, other infections, bed sores

  • Composite score for complications [ Time Frame: ICU discharge (maximum of 28 days) ]
    Presence/absence of at least one of the following complications: on-catheter bacteremia, ventilator acquired pneumonia, other infections, bed sores

  • 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) ]

Enrollment: 0
Study Start Date: October 2015
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01749488

Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Principal Investigator: Saber Davide Barbar, MD Centre Hospitalier Universitaire de Nîmes
Study Director: Jean-Yves Lefrant, MD, PhD Centre Hospitalier Universitaire de Nîmes
  More Information

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT01749488     History of Changes
Other Study ID Numbers: PHRC-I/2012/SB-01
2012-A00626-37 ( Other Identifier: RCB number )
Study First Received: December 12, 2012
Last Updated: August 2, 2016

Keywords provided by Centre Hospitalier Universitaire de Nīmes:
Dietitian
Nutritional recommendations
ICU nutrition

ClinicalTrials.gov processed this record on April 26, 2017