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

Intensive Care Clinical Trial

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Official title:

The Impact of Involving a Dietitian in the Implementation of Expert Recommendations Concerning Nutrition During Intensive Care on Energy Balance

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01749488
• Other study ID #: PHRC-I/2012/SB-01
• Secondary ID: 2012-A00626-37
• Status: Withdrawn
• Phase: N/A
• First received: December 12, 2012
• Last updated: August 2, 2016
• Start date: October 2015
• Est. completion date: April 2018

Study information

• Verified date: August 2016
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of PersonnesFrance: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2018
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Intensive Care

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Caloric deficit accumulated over 7 days	Caloric deficit accumulated over 7 days (kcal/kg)	Day 7	No
Secondary	Average per day caloric deficit	Average per day caloric deficit (kcal/kg/day)	Day 7	No
Secondary	Caloric deficit accumulated during the ICU stay	Caloric deficit accumulated during the ICU stay (kcal/kg)	ICU discharge (maximum of 28 days)	No
Secondary	Average per-day protein deficit	Average per-day protein deficit (grams protein/kg/day)	Day 7	No
Secondary	Protein deficit accumulated over 7 days	Protein deficit accumulated over 7 days (grams protein/kg)	Day 7	No
Secondary	Protein deficit accumulated during the ICU stay	Protein deficit accumulated during the ICU stay (grams protein/kg)	ICU discharge (maximum of 28 days)	No
Secondary	Average per day amounts of vitamins received		Day 7	No
Secondary	Average per day amounts of trace elements received		Day 7	No
Secondary	Average per day amounts of pharmaco nutrients received		Day 7	No
Secondary	Percentage of calories received by enteral route	daily average	Day 7	No
Secondary	Percentage of calories received by enteral route	accumulated over 7 days	Day 7	No
Secondary	Percentage of calories received by enteral route	accumulated over ICU stay	ICU discharge (maximum of 28 days)	No
Secondary	Percentage of proteins received by enteral route	daily average	Day 7	No
Secondary	Percentage of proteins received by enteral route	accumulated over 7 days	Day 7	No
Secondary	Percentage of proteins received by enteral route	accumulated over ICU stay	ICU discharge (maximum of 28 days)	No
Secondary	length of time spent on ventilator (hours)		ICU discharge (maximum of 28 days)	No
Secondary	length of ICU stay (days)		ICU discharge (maximum of 28 days)	No
Secondary	Number of days spent with (any) organ failure		ICU discharge (maximum of 28 days)	No
Secondary	Number of days on antibiotics		ICU discharge (maximum of 28 days)	No
Secondary	Mortality (yes/no)		Day 90	Yes
Secondary	Mortality (yes/no)		Day 180	Yes
Secondary	Presence/absence of on-catheter bacteremia		Day 7	Yes
Secondary	Presence/absence of on-catheter bacteremia		Day 28	Yes
Secondary	Presence/absence of on-catheter bacteremia		ICU discharge (maximum of 28 days)	Yes
Secondary	Presence/absence of ventilator acquired pneumonia		Day 7	Yes
Secondary	Presence/absence of ventilator acquired pneumonia		Day 28	Yes
Secondary	Presence/absence of ventilator acquired pneumonia		ICU discharge (maximum of 28 days)	Yes
Secondary	Presence/absence of other infections		Day 7	No
Secondary	Presence/absence of other infections		Day 28	No
Secondary	Presence/absence of other infections		ICU discharge (maximum of 28 days)	No
Secondary	Presence/absence of bed sores		Day 7	No
Secondary	Presence/absence of bed sores		Day 28	No
Secondary	Presence/absence of bed sores		ICU discharge (maximum of 28 days)	No
Secondary	Composite score for complications	Presence/absence of at least one of the following complications: on-catheter bacteremia, ventilator acquired pneumonia, other infections, bed sores	Day 7	No
Secondary	Composite score for complications	Presence/absence of at least one of the following complications: on-catheter bacteremia, ventilator acquired pneumonia, other infections, bed sores	Day 28	No
Secondary	Composite score for complications	Presence/absence of at least one of the following complications: on-catheter bacteremia, ventilator acquired pneumonia, other infections, bed sores	ICU discharge (maximum of 28 days)	No
Secondary	Minimum observed glycemia		Day 7	No
Secondary	Minimum observed glycemia		ICU discharge (maximum of 28 days)	No
Secondary	Maximum observed glycemia		Day 7	No
Secondary	Maximum observed glycemia		ICU discharge (maximum of 28 days)	No
Secondary	Average observed glycemia		Day 7	No
Secondary	Average observed glycemia		ICU discharge (maximum of 28 days)	No
Secondary	Presence/absence of a glycemia measure < 0.4 g/l		Day 7	No
Secondary	Presence/absence of a glycemia measure < 0.4 g/l		ICU discharge (maximum of 28 days)	No
Secondary	Presence/absence of a glycemia measure > 1.8 g/l		Day 7	No
Secondary	Presence/absence of a glycemia measure > 1.8 g/l		ICU discharge (maximum of 28 days)	No
Secondary	Presence/absence of hypertriglyceridemia		Day 7	No
Secondary	Presence/absence of hypertriglyceridemia		ICU discharge (maximum of 28 days)	No
Secondary	Accumulated cost of enteral nutrition		Between Day 0 and ICU discharge (expected maximum of 28 days)	No
Secondary	Accumulated cost of parenteral nutrition		Between Day 0 and ICU discharge (expected maximum of 28 days)	No
Secondary	Accumulated cost of antibiotics		Between Day 0 and ICU discharge (expected maximum of 28 days)	No
Secondary	Accumulated cost of sedation		Between Day 0 and ICU discharge (expected maximum of 28 days)	No
Secondary	Presence/absence of diarrhea		Between Day 0 and ICU discharge (expected maximum of 28 days)	Yes
Secondary	Accumulated cost of nutritional supplements		Between Day 0 and ICU discharge (expected maximum of 28 days)	No
Secondary	Accumulated cost of ICU stay		Between Day 0 and ICU discharge (expected maximum of 28 days)	No