Follow-up of Malnutrition Screening in USINV

Stroke Clinical Trial

— DENUTRITION  

Official title:

Follow-up of Malnutrition Screening in Neurovascular Intensive Care Unit

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03728400
• Other study ID #: DENUTRITION USINV
• Status: Active, not recruiting
• Start date: May 29, 2018
• Est. completion date: December 30, 2023

Study information

• Verified date: March 2023
• Source: Groupe Hospitalier Paris Saint Joseph
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This aim of the study is to set up a procedure for screening for undernutrition in the neurovascular intensive care unit. This screening procedure follows a specific work concerning undernutrition in thrombolyzed patients (NCT03303820). This work was motivated by the fact that, despite a high frequency of undernutrition in the hospital (at least 30% of patients), undernutrition in neurovascular unit is studied very little. A cohort of thrombolysed patients in 2014 was studied retrospectively. Patients malnourished at the entrance had a non-significant, less good recovery of their stroke (+ 1 Rankin score point at 3 months in malnourished patients at the entrance).

Description:

The main objective of this project is to assess, prospectively, the frequency of undernutrition at the entrance to the neurovascular intensive care unit and to evaluate the implementation of the undernutrition screening procedure.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 66
• Est. completion date: December 30, 2023
• Est. primary completion date: August 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

Inclusion Criteria:

• Patient whose age = 70 years
• Patient hospitalized in Neurovascular Intensive care Unit following a stroke (infarction or cerebral hematoma)
• Francophone patient

Exclusion Criteria:

• Patient hospitalized in Neurovascular Intensive care Unit following a transient ischemic attack
• Patient whose age = 70 years
• Patient hospitalized in Neurovascular Intensive care Unit for another reason than neurovascular disease
• Patient opposing the use of his data

Related Conditions & MeSH terms

• Malnutrition
• Stroke

Locations

Country	Name	City	State
France	Groupe Hospitalier Paris Saint-Joseph	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier Paris Saint Joseph

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	frequency of undernutrition at the entrance	The primary endpoint is the number of patients who have had an assessment of their nutritional status, that is, for whom undernutrition is detected according to the terms proposed in the undernutrition screening procedure: search for previous quantified weight loss, input BMI, albuminemia.	Day 1
Secondary	Modified Rankin scale	The Rankin score will be performed in post stroke consultation, 3 months after inclusion. Rankin scale: 0 no symptoms, 1 No significant disability. Able to carry out all usual activities, despite some symptoms, 2 Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities, 3 Moderate disability. Requires some help, but able to walk unassisted, 4 Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted, 5 Severe disability. Requires constant nursing care and attention, bedridden, incontinent	3 months
Secondary	Recurrence rate of ischemic or haemorrhagic stroke	The recurrence of stroke will be collected during the post stroke consultation, 3 months after inclusion.	3 months