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

NCT01749488 | Withdrawn

• 2 other identifiers: PHRC-I/2012/SB-012012-A00626-37
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Intensive Care

Keywords

Dietitian; Nutritional recommendations; ICU nutrition

Outcome Measures

Primary Outcomes (1)

• Caloric deficit accumulated over 7 days

  Caloric deficit accumulated over 7 days (kcal/kg)

  Day 7

Secondary Outcomes (54)

• Average per day caloric deficit

  Day 7

• Caloric deficit accumulated during the ICU stay

  ICU discharge (maximum of 28 days)

• Average per-day protein deficit

  Day 7

• Protein deficit accumulated over 7 days

  Day 7

• Protein deficit accumulated during the ICU stay

  ICU discharge (maximum of 28 days)

Study Arms (2)

Control intensive care wards

NO INTERVENTION

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 intensive care wards

EXPERIMENTAL

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

Interventions

Designated dietitian for the ward 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.

Experimental intensive care wards

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Officials

• Saber Davide Barbar, MD

  Centre Hospitalier Universitaire de Nîmes

  PRINCIPAL INVESTIGATOR

• Jean-Yves Lefrant, MD, PhD

  Centre Hospitalier Universitaire de Nîmes

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2012
• First Posted: December 13, 2012
• Study Start: October 1, 2015
• Primary Completion: October 1, 2017
• Study Completion: April 1, 2018
• Last Updated: August 3, 2016

Record last verified: 2016-08