Nutritional Status at the Release of ICU.FEEDINGNCT01750671
Influence Of Nutritional Status Of Patients In The Intensive Care Output On Long Term Fate
An observational study of Nutritional Status at the Release of ICU., run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
It is established that the surviving patients after a stay in the ICU are characterized by frequent malnutrition and morbidity and mortality. The main goal of this work is to study the relationship between nutritional statuses during ICU hospitalization, whatever its determinants, and quality of life, morbidity and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nutritional Status at the Release of ICU.
- How many people
- 680 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2012to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients malnourished and non-malnourished
Who may be able to join
- Patients of both sexes, age greater than or equal to 18 years
- Hospitalized more than 72 hours in the ICU
- Requiring at least one support organ failure:
- Ventilatory support (invasive or noninvasive)
- Administration of catecholamines
- Extrarenal purification whatever technique
- Affiliated to a social security system
- Having given free, informed written consent
Who cannot join
- Patients with end-stage disease or for which a limitation of care was decided
- Pregnant women
- Patients with minor or under guardianship
- Incapacitated adults and psychiatric inpatients
Trial locations and contacts
1 site in 1 country.
France1 site
Chu de Clermont-Ferrand
Clermont-Ferrand, 63003
Patrick LACARIN, 04 73 75 11 95, placarin@chu-clermontferrand.fr
Noël CANO
About this study
It is established that the surviving patients after a stay in the ICU are characterized by frequent malnutrition and morbidity and mortality. The main goal of this work is to study the relationship between nutritional statuses during ICU hospitalization, whatever its determinants, and quality of life, morbidity and mortality at one year.
The hypothesis of the study is that the presence of under nutrition is responsible for a 10% increase in crude mortality at one year (which would be respectively 30% for malnourished patients and 20% for non-malnourished patients).
Read the detailed description
This is a multicenter cohort study of a 30-month follow-up on patients after a stay in ICU.
Nutritional parameters and evaluation of the quality of life will be collected during hospitalization and output during a visit to the Clinical Research Associate at 6 months and one year. Survival will be also noted. These parameters will be studied in comparative patients malnourished and non-malnourished.
- Keywords
- ICU, Body composition, Nutrition, Survival, Morbidity
What is being measured
The primary outcome is the main question the study is designed to answer.
all-cause mortality
Measured: at one year
Secondary outcomes (10)
Anxiety and depression
Measured: at inclusion, M6 and M12
Post-traumatic stress
Measured: at inclusion, M6 and M12
Quality of life
Measured: at M6 and M12
Degree of activity (Karnofsky questionnaire)
Measured: At M6 and M12
Weight
Measured: at inclusion, M6 and M12
Body mass index
Measured: at inclusion, M6 and M12
Albumin
Measured: at inclusion, M6 and M12
Orosomucoid
Measured: at inclusion, M6 and M12
Transthyretin (prealbumin)
Measured: at inclusion, M6 and M12
Body composition
Measured: at inclusion, M6 and M12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionMay 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutritional Status at the Release of ICU.Studies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Enrolment
- 680 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Société des Produits Nestlé (SPN), Baxter S.A.S, University Hospital, Strasbourg, France, Hospices Civils de Lyon
- Responsible party
- Sponsor
- Investigators
- Noël CANO, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01750671
- Sponsor's protocol ID
- CHU-0127
- Acronym
- FEEDING
- Status last verified
- Dec 2012
- First submitted
- 16 Nov 2012
- Last updated
- 17 Dec 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence Of Nutritional Status Of Patients In The Intensive Care Output On Long Term Fate
- ClinicalTrials.gov ID
- NCT01750671
- Acronym / sponsor ID
- FEEDING / CHU-0127
- Keywords
- ICU, Body composition, Nutrition, Survival, Morbidity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 680 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Société des Produits Nestlé (SPN), Baxter S.A.S, University Hospital, Strasbourg, France, Hospices Civils de Lyon
- Study start
- Dec 2012
- Primary completion
- May 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 17 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It is established that the surviving patients after a stay in the ICU are characterized by frequent malnutrition and morbidity and mortality. The main goal of this work is to study the relationship between nutritional statuses during ICU hospitalization, whatever its determinants, and quality of life, morbidity and mortality at one year.
The hypothesis of the study is that the presence of under nutrition is responsible for a 10% increase in crude mortality at one year (which would be respectively 30% for malnourished patients and 20% for non-malnourished patients).
Detailed description
This is a multicenter cohort study of a 30-month follow-up on patients after a stay in ICU.
Nutritional parameters and evaluation of the quality of life will be collected during hospitalization and output during a visit to the Clinical Research Associate at 6 months and one year. Survival will be also noted. These parameters will be studied in comparative patients malnourished and non-malnourished.
Study design
- Observational model
- Cohort
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients malnourished and non-malnourished
Key inclusion criteria (8 listed)
- Patients of both sexes, age greater than or equal to 18 years
Key exclusion criteria (4 listed)
- Patients with end-stage disease or for which a limitation of care was decided
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
all-cause mortality
Time frame: at one year
10 secondary outcomes
Anxiety and depression
Time frame: at inclusion, M6 and M12
Post-traumatic stress
Time frame: at inclusion, M6 and M12
Quality of life
Time frame: at M6 and M12
Degree of activity (Karnofsky questionnaire)
Time frame: At M6 and M12
Weight
Time frame: at inclusion, M6 and M12
Body mass index
Time frame: at inclusion, M6 and M12
Albumin
Time frame: at inclusion, M6 and M12
Orosomucoid
Time frame: at inclusion, M6 and M12
Transthyretin (prealbumin)
Time frame: at inclusion, M6 and M12
Body composition
Time frame: at inclusion, M6 and M12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2012.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noël CANO principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nutritional Status at the Release of ICU., run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick LACARIN (04 73 75 11 95, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all-cause mortality (time frame: at one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2012.