WithdrawnNot Applicable

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

Stopped: The intervention becomes obsolete for participating centres pending regulatories.

0Started 2015-10

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Caloric deficit accumulated over 7 days

Timeframe: Day 7

Trial details

NCT IDNCT01749488

SponsorCentre Hospitalier Universitaire de Nīmes

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-10

View on ClinicalTrials.gov More Intensive Care trials