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

NCT ID: NCT01749488

Last Updated: 2016-08-03

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2018-04-30

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

Conditions

Intensive Care

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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

Group Type: EXPERIMENTAL

Designated dietitian for the ward

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Saber Davide Barbar, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nîmes

Jean-Yves Lefrant, MD, PhD

Role: STUDY_DIRECTOR

Centre Hospitalier Universitaire de Nîmes

Other Identifiers

2012-A00626-37

Identifier Type: OTHER

Identifier Source: secondary_id

PHRC-I/2012/SB-01

Identifier Type: -

Identifier Source: org_study_id