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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06317402
Other study ID # APHP240133
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 9, 2024
Est. completion date September 9, 2025

Study information

Verified date April 2024
Source Assistance Publique - Hôpitaux de Paris
Contact Pauline Faucher, Dr
Phone 01 42 17 57 71
Email pauline.faucher@aphp.fr
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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. 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).


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).


Recruitment information / eligibility

Status Recruiting
Enrollment 385
Est. completion date September 9, 2025
Est. primary completion date September 9, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
malnutrition questionary
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.

Locations

Country Name City State
France Service de nutrition, Hôpital Pitié-Salpêtrière Paris

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 3 days
Secondary 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. 6 months
Secondary 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. 6 months
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