MalnutritionEPIDENUT_PSLNCT06317402
Epidemiology and Management of Malnutrition of Patients Hospitalized at the Pitié-Salpêtrière Hospital: a One-day Survey Combined With Focus Groups (Mixed Methods)
An observational study of Malnutrition, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
According to the literature, malnutrition affects between 30% and 50% of hospitalized patients. The most recent survey on the prevalence of malnutrition in hospitals in France dates back to 2003, and at the Pitié Salpêtrière Hospital to 2015. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malnutrition
- What is being tested?
- malnutrition questionary
- How many people
- 385 participants
- Where
- 1 siteFrance
- Study dates
- 15 May 2024to 9 Sep 2025
- How long will I take part?
- 2 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Adult patients hospitalized at Pitié Salpêtrière in conventional hospitalization wards (medical and surgical wards)
Who may be able to join
- Age ≥ 18 years
- Hospitalized for at least 2 days in a Pitié Salpêtrière department of the 8 selected DMUs.
- Patient informed and not objecting to participation in the study.
Who cannot join
- Be hospitalized in a PRM, SMR, radiotherapy or adult psychiatry department
- Be hospitalized in an intensive care or resuscitation unit of the 8 selected DMU
- Be at the end of life, as determined by the referring clinician
- Have a communication barrier preventing the collection of declarative data
- Pregnancy in progress; 6. Patient under guardianship.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Service de nutrition, Hôpital Pitié-Salpêtrière
Paris, France, 75013
Pauline Faucher, Dr, 01 42 17 57 71 ext. 33, pauline.faucher@aphp.fr
About this study
Official title: Evaluate the Prevalence of Undernutrition in Adult Patients Hospitalized on a Given Day at the Pitié-Salpêtrière Hospital (PSL) According to HAS Criteria in 2019 (if Age <70 Years) and 2021 (if Age ≥ 70 Years)
According to the literature, malnutrition affects between 30% and 50% of hospitalized patients. The most recent survey on the prevalence of malnutrition in hospitals in France dates back to 2003, and at the Pitié Salpêtrière Hospital to 2015. Malnutrition is a pathological process that can lead to complications for patients and prolong their length of stay.
Main objective: Evaluate the prevalence of malnutrition in adult patients hospitalized on a given day at Pitié-Salpêtrière Hospital (PSL) according to HAS ( High Authority for Health) criteria for 2019 (if age <70 years) and 2021 (if age ≥ 70 years).
Read the detailed description
According to the literature, malnutrition affects between 30% and 50% of hospitalized patients. The most recent survey on the prevalence of malnutrition in hospitals in France dates back to 2003, and at the Pitié Salpêtrière Hospital to 2015. Malnutrition is a pathological process that can lead to complications for patients and prolong their length of stay.
Main objective: Evaluate the prevalence of malnutrition in adult patients hospitalized on a given day at Pitié-Salpêtrière Hospital (PSL) according to HAS (High Authority for Health) criteria for 2019 (if age <70 years) and 2021 (if age ≥ 70 years).
- Conditions
- Malnutrition
- Being tested
- malnutrition questionary
- Keywords
- malnutrition
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
malnutrition questionaryOther
At the patient's bed, using a questionnaire, evaluators take anthropometric measurements (weight, height, muscle strength) and collect biological data (albumin, pre-albumin, CRP, if available in the medical record) to establish nutritional status according to HAS criteria for undernutrition 2019-2021 and 2003-2007.
| Study group | Role | What they receive |
|---|---|---|
| patient | Adult patients hospitalized at Pitié Salpêtrière in conventional hospitalization wards Receives: Other: malnutrition questionary |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of undernutrition diagnosed according to HAS 2019 and 2021 criteria on a given day in hospitalized PSL patients.
The survey is conducted over 3 days due to : - The mobilization of medical and paramedical staff for the undernutrition screening phase is only possible over a limited period of time. - The patients to be assessed will be drawn at random from a list provided by the Admissions department ; the draw will then be carried out by the Public Health department (excluding the ORIGYNE DMU, the PRM and respiratory and neurorespiratory SSR departments, and the radiotherapy department (few hospitalizations lasting more than 24-48 hours)). In addition, it is important to specify that, if at the end of phase 1 of the survey, the auditor (dietician and/or doctor) finds that a patient is undernourished, the auditor will inform the department's referring doctor within 24 hours. The resulting treatment will be carried out by the referring dietician on the basis of a medical prescription.
Measured: 3 days
Secondary outcomes (2)
Compare the prevalence and the severity of undernutrition in hospitalized PSL patients according to the HAS criteria of 2019 (if age <70 years) and 2021 (if age ≥ 70 years) versus those of 2003 (if age <70 years) and 2007 (if age ≥ 70 years).
Phase 1 : HAS malnutrition criteria 2019-2021 and 2003-2007.
Measured: 6 months
Evaluate the quality of nutritional management for malnourished patients hospitalized at PSL. Using PMSI coding, assess the value of activities associated with undernutrition in undernourished patients hospitalized at PSL.
Phase 2 : The quality of nutritional management of malnourished patients will be assessed using several judgment criteria extracted from patient records in Orbis, for the sub-group of patients hospitalized on the given day and diagnosed as malnourished during the 1st evaluation phase. Phase 3: Transmission of the list of NIP.IPP codes for patients diagnosed as undernourished to the DIM (Département d'Information Médicale) team for extraction of codes for diagnosis of undernutrition and procedures associated with its management.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start15 May 2024
- Primary completion9 Sep 2025 (estimated)
- Study completion9 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Time perspective
- Prospective
- Enrolment
- 385 participants (estimated)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pauline Faucher, Dr, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06317402
- Sponsor's protocol ID
- APHP240133
- Acronym
- EPIDENUT_PSL
- Status last verified
- Jun 2025
- First submitted
- 12 Mar 2024
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate the Prevalence of Undernutrition in Adult Patients Hospitalized on a Given Day at the Pitié-Salpêtrière Hospital (PSL) According to HAS Criteria in 2019 (if Age <70 Years) and 2021 (if Age ≥ 70 Years)
- ClinicalTrials.gov ID
- NCT06317402
- Acronym / sponsor ID
- EPIDENUT_PSL / APHP240133
- Conditions
- Malnutrition
- Keywords
- malnutrition
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 385 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 15 May 2024 (actual)
- Primary completion
- 9 Sep 2025 (estimated)
- Study completion
- 9 Sep 2025 (estimated)
- First posted
- 19 Mar 2024 (actual)
- 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.
According to the literature, malnutrition affects between 30% and 50% of hospitalized patients. The most recent survey on the prevalence of malnutrition in hospitals in France dates back to 2003, and at the Pitié Salpêtrière Hospital to 2015. Malnutrition is a pathological process that can lead to complications for patients and prolong their length of stay.
Main objective: Evaluate the prevalence of malnutrition in adult patients hospitalized on a given day at Pitié-Salpêtrière Hospital (PSL) according to HAS ( High Authority for Health) criteria for 2019 (if age <70 years) and 2021 (if age ≥ 70 years).
Detailed description
According to the literature, malnutrition affects between 30% and 50% of hospitalized patients. The most recent survey on the prevalence of malnutrition in hospitals in France dates back to 2003, and at the Pitié Salpêtrière Hospital to 2015. Malnutrition is a pathological process that can lead to complications for patients and prolong their length of stay.
Main objective: Evaluate the prevalence of malnutrition in adult patients hospitalized on a given day at Pitié-Salpêtrière Hospital (PSL) according to HAS (High Authority for Health) criteria for 2019 (if age <70 years) and 2021 (if age ≥ 70 years).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patient | – | Other: malnutrition questionaryAdult patients hospitalized at Pitié Salpêtrière in conventional hospitalization wards |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients hospitalized at Pitié Salpêtrière in conventional hospitalization wards (medical and surgical wards)
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Hospitalized for at least 2 days in a Pitié Salpêtrière department of the 8 selected DMUs.
- Patient informed and not objecting to participation in the study.
Key exclusion criteria (5 listed)
- Be hospitalized in a PRM, SMR, radiotherapy or adult psychiatry department
- Be hospitalized in an intensive care or resuscitation unit of the 8 selected DMU
- Be at the end of life, as determined by the referring clinician
- Have a communication barrier preventing the collection of declarative data
- Pregnancy in progress; 6. Patient under guardianship.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| malnutrition questionaryAt the patient's bed, using a questionnaire, evaluators take anthropometric measurements (weight, height, muscle strength) and collect biological data (albumin, pre-albumin, CRP, if available in the medical record) to establish nutritional status according to HAS criteria for undernutrition 2019-2021 and 2003-2007. | Other | patient |
Primary outcome
Prevalence of undernutrition diagnosed according to HAS 2019 and 2021 criteria on a given day in hospitalized PSL patients.
Time frame: 3 days
The survey is conducted over 3 days due to : - The mobilization of medical and paramedical staff for the undernutrition screening phase is only possible over a limited period of time. - The patients to be assessed will be drawn at random from a list provided by the Admissions department ; the draw will then be carried out by the Public Health department (excluding the ORIGYNE DMU, the PRM and respiratory and neurorespiratory SSR departments, and the radiotherapy department (few hospitalizations lasting more than 24-48 hours)). In addition, it is important to specify that, if at the end of phase 1 of the survey, the auditor (dietician and/or doctor) finds that a patient is undernourished, the auditor will inform the department's referring doctor within 24 hours. The resulting treatment will be carried out by the referring dietician on the basis of a medical prescription.
2 secondary outcomes
Compare the prevalence and the severity of undernutrition in hospitalized PSL patients according to the HAS criteria of 2019 (if age <70 years) and 2021 (if age ≥ 70 years) versus those of 2003 (if age <70 years) and 2007 (if age ≥ 70 years).
Time frame: 6 months
Evaluate the quality of nutritional management for malnourished patients hospitalized at PSL. Using PMSI coding, assess the value of activities associated with undernutrition in undernourished patients hospitalized at PSL.
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
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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.
Pauline Faucher, Dr principal investigator
Assistance Publique - Hôpitaux de Paris
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 Malnutrition, run by Assistance Publique - Hôpitaux de Paris 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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 3 Jul 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pauline Faucher, Dr (01 42 17 57 71 ext. 33, pauline.faucher@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of undernutrition diagnosed according to HAS 2019 and 2021 criteria on a given day in hospitalized PSL patients. (time frame: 3 days). 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 3 Jul 2025.