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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2014 by Centre Hospitalier Universitaire de Nīmes
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01749488
First received: December 12, 2012
Last updated: November 18, 2014
Last verified: November 2014
  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
Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: No ]
    Caloric deficit accumulated over 7 days (kcal/kg)


Secondary Outcome Measures:
  • Average per day caloric deficit [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
    Average per day caloric deficit (kcal/kg/day)

  • Caloric deficit accumulated during the ICU stay [ Time Frame: ICU discharge (maximum of 28 days) ] [ Designated as safety issue: No ]
    Caloric deficit accumulated during the ICU stay (kcal/kg)

  • Average per-day protein deficit [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
    Average per-day protein deficit (grams protein/kg/day)

  • Protein deficit accumulated over 7 days [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
    Protein deficit accumulated over 7 days (grams protein/kg)

  • Protein deficit accumulated during the ICU stay [ Time Frame: ICU discharge (maximum of 28 days) ] [ Designated as safety issue: No ]
    Protein deficit accumulated during the ICU stay (grams protein/kg)

  • Average per day amounts of vitamins received [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
  • Average per day amounts of trace elements received [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
  • Average per day amounts of pharmaco nutrients received [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
  • Percentage of calories received by enteral route [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
    daily average

  • Percentage of calories received by enteral route [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
    accumulated over 7 days

  • Percentage of calories received by enteral route [ Time Frame: ICU discharge (maximum of 28 days) ] [ Designated as safety issue: No ]
    accumulated over ICU stay

  • Percentage of proteins received by enteral route [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
    daily average

  • Percentage of proteins received by enteral route [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
    accumulated over 7 days

  • Percentage of proteins received by enteral route [ Time Frame: ICU discharge (maximum of 28 days) ] [ Designated as safety issue: No ]
    accumulated over ICU stay

  • length of time spent on ventilator (hours) [ Time Frame: ICU discharge (maximum of 28 days) ] [ Designated as safety issue: No ]
  • length of ICU stay (days) [ Time Frame: ICU discharge (maximum of 28 days) ] [ Designated as safety issue: No ]
  • Number of days spent with (any) organ failure [ Time Frame: ICU discharge (maximum of 28 days) ] [ Designated as safety issue: No ]
  • Number of days on antibiotics [ Time Frame: ICU discharge (maximum of 28 days) ] [ Designated as safety issue: No ]
  • Mortality (yes/no) [ Time Frame: Day 90 ] [ Designated as safety issue: Yes ]
  • Mortality (yes/no) [ Time Frame: Day 180 ] [ Designated as safety issue: Yes ]
  • Presence/absence of on-catheter bacteremia [ Time Frame: Day 7 ] [ Designated as safety issue: Yes ]
  • Presence/absence of on-catheter bacteremia [ Time Frame: Day 28 ] [ Designated as safety issue: Yes ]
  • Presence/absence of on-catheter bacteremia [ Time Frame: ICU discharge (maximum of 28 days) ] [ Designated as safety issue: Yes ]
  • Presence/absence of ventilator acquired pneumonia [ Time Frame: Day 7 ] [ Designated as safety issue: Yes ]
  • Presence/absence of ventilator acquired pneumonia [ Time Frame: Day 28 ] [ Designated as safety issue: Yes ]
  • Presence/absence of ventilator acquired pneumonia [ Time Frame: ICU discharge (maximum of 28 days) ] [ Designated as safety issue: Yes ]
  • Presence/absence of other infections [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
  • Presence/absence of other infections [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
  • Presence/absence of other infections [ Time Frame: ICU discharge (maximum of 28 days) ] [ Designated as safety issue: No ]
  • Presence/absence of bed sores [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
  • Presence/absence of bed sores [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
  • Presence/absence of bed sores [ Time Frame: ICU discharge (maximum of 28 days) ] [ Designated as safety issue: No ]
  • Composite score for complications [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Minimum observed glycemia [ Time Frame: ICU discharge (maximum of 28 days) ] [ Designated as safety issue: No ]
  • Maximum observed glycemia [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
  • Maximum observed glycemia [ Time Frame: ICU discharge (maximum of 28 days) ] [ Designated as safety issue: No ]
  • Average observed glycemia [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
  • Average observed glycemia [ Time Frame: ICU discharge (maximum of 28 days) ] [ Designated as safety issue: No ]
  • Presence/absence of a glycemia measure < 0.4 g/l [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
  • Presence/absence of a glycemia measure < 0.4 g/l [ Time Frame: ICU discharge (maximum of 28 days) ] [ Designated as safety issue: No ]
  • Presence/absence of a glycemia measure > 1.8 g/l [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
  • Presence/absence of a glycemia measure > 1.8 g/l [ Time Frame: ICU discharge (maximum of 28 days) ] [ Designated as safety issue: No ]
  • Presence/absence of hypertriglyceridemia [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
  • Presence/absence of hypertriglyceridemia [ Time Frame: ICU discharge (maximum of 28 days) ] [ Designated as safety issue: No ]
  • Accumulated cost of enteral nutrition [ Time Frame: Between Day 0 and ICU discharge (expected maximum of 28 days) ] [ Designated as safety issue: No ]
  • Accumulated cost of parenteral nutrition [ Time Frame: Between Day 0 and ICU discharge (expected maximum of 28 days) ] [ Designated as safety issue: No ]
  • Accumulated cost of antibiotics [ Time Frame: Between Day 0 and ICU discharge (expected maximum of 28 days) ] [ Designated as safety issue: No ]
  • Accumulated cost of sedation [ Time Frame: Between Day 0 and ICU discharge (expected maximum of 28 days) ] [ Designated as safety issue: No ]
  • Presence/absence of diarrhea [ Time Frame: Between Day 0 and ICU discharge (expected maximum of 28 days) ] [ Designated as safety issue: Yes ]
  • Accumulated cost of nutritional supplements [ Time Frame: Between Day 0 and ICU discharge (expected maximum of 28 days) ] [ Designated as safety issue: No ]
  • Accumulated cost of ICU stay [ Time Frame: Between Day 0 and ICU discharge (expected maximum of 28 days) ] [ Designated as safety issue: No ]

Estimated Enrollment: 392
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
Genders Eligible for Study:   Both
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

Contacts
Contact: Saber Davide Barbar, MD +33.(0)4.66.68.33.20 saber.barbar@chu-nimes.fr
Contact: Carey Suehs, PhD +33.(0)4.66.68.67.88 carey.suehs@chu-nimes.fr

Locations
Belgium
Hôpital Erasme Active, not recruiting
Bruxelles, Belgium, 1070
France
CH d'Avignon - Centre Hospitalier Henri Duffaut Not yet recruiting
Avignon, France, 84902
Sub-Investigator: Pierre Courant, MD         
CHU de Dijon Not yet recruiting
Dijon, France, 21079
Sub-Investigator: Jean Pierre Quenot, MD         
APHM - Hôpital Sainte-Marguerite Not yet recruiting
Marseille, France, 13274
Sub-Investigator: Laurent Papazian, MD, PhD         
APHM - Hôpital Nord Not yet recruiting
Marseille Cedex 20, France, 13915
Sub-Investigator: Marc Léone, MD, PhD         
CHU de Montpellier - Hôpital Lapeyronie Active, not recruiting
Montpellier, France, 34295
CHU de Montpellier - Hôpital Saint-Eloi Not yet recruiting
Montpellier, France, 34295
Sub-Investigator: Samir Jaber, MD, PhD         
CH de Narbonne Not yet recruiting
Narbonne cedex, France, 11108
Sub-Investigator: Jérôme Larché, MD         
CHU de Nice - Hôpital St-Roch Not yet recruiting
Nice, France, 06006
Sub-Investigator: Carole Ichai, MD, PhD         
CHU de Nîmes - Hôpital Universitaire Carémeau Not yet recruiting
Nîmes Cedex 9, France, 30029
Principal Investigator: Saber Davide Barbar, MD         
Sub-Investigator: Jean-Yves Lefrant, MD, PhD         
Switzerland
Centre Hospitalier Universitaire Vaudois Active, not recruiting
Lausanne, Switzerland, CH-1011
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

No publications provided

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
Study First Received: December 12, 2012
Last Updated: November 18, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
France: Committee for the Protection of Personnes

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

ClinicalTrials.gov processed this record on November 27, 2014