The Impact of a Dietitian in the Implementation of Nutrition Recommendations During Intensive Care (NutriSave)
This study is not yet open for participant recruitment.
Verified May 2013 by Centre Hospitalier Universitaire de Nīmes
Sponsor:
Centre Hospitalier Universitaire de Nīmes
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01749488
First received: December 12, 2012
Last updated: May 14, 2013
Last verified: May 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
Resource links provided by NLM:
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: Day 7 ] [ Designated as safety issue: No ]
- Accumulated cost of enteral nutrition [ Time Frame: ICU discharge (maximum of 28 days) ] [ Designated as safety issue: No ]
- Accumulated cost of parenteral nutrition [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
- Accumulated cost of parenteral nutrition [ Time Frame: ICU discharge (maximum of 28 days) ] [ Designated as safety issue: No ]
- Accumulated cost of antibiotics [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
- Accumulated cost of antibiotics [ Time Frame: ICU discharge (maximum of 28 days) ] [ Designated as safety issue: No ]
- Accumulated cost of sedation [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
- Accumulated cost of sedation [ Time Frame: ICU discharge (maximum of 28 days) ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 392 |
| Study Start Date: | September 2013 |
| Estimated Study Completion Date: | February 2014 |
| Estimated Primary Completion Date: | February 2014 (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
- costs directly related to enteral and parenteral nutritional support, and costs related to infectious complications
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"
- 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
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 du Pays d'Aix | Not yet recruiting |
| Aix en Provence, France, 13616 | |
| Sub-Investigator: Bernard Garrigue, MD | |
| Sub-Investigator: Olivier Baldési, MD | |
| CH d'Avignon - Centre Hospitalier Henri Duffaut | Not yet recruiting |
| Avignon, France, 84902 | |
| Sub-Investigator: Pierre Courant, MD | |
| CH de Beziers | Not yet recruiting |
| Béziers, France, 34525 | |
| Sub-Investigator: Laurent Favier, 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 Saint-Eloi | Not yet recruiting |
| Montpellier, France, 34295 | |
| Sub-Investigator: Samir Jaber, MD, PhD | |
| CHU de Montpellier - Hôpital Lapeyronie | Active, not recruiting |
| Montpellier, France, 34295 | |
| 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 Nice - Hôpitaux L'Archet 1 et 2 | Not yet recruiting |
| Nice, France, 06202 | |
| Sub-Investigator: Jean Dellamonica, 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: | May 14, 2013 |
| Health Authority: | France: L’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 May 16, 2013