Follow-up of Malnutrition Screening in USINV

Active, not recruiting

• Conditions: Stroke

• Registration Number: NCT03728400
• Lead Sponsor: Fondation Hôpital Saint-Joseph

Brief 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).

Detailed 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.

Study Timeline

• Study Start: 2018-05-29
• Study First Submitted: 2018-10-31
• Study First Submitted QC: 2018-10-31
• Study First Posted: 2018-11-02
• Primary Completion: 2019-08-30
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-06
• Last Update Posted: 2023-03-07
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
frequency of undernutrition at the entrance	Day 1	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.

Secondary Outcome Measures

Name	Time	Method
Recurrence rate of ischemic or haemorrhagic stroke	3 months	The recurrence of stroke will be collected during the post stroke consultation, 3 months after inclusion.
Modified Rankin scale	3 months	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

Trial Locations

Locations (1)

Groupe Hospitalier Paris Saint-Joseph; 🇫🇷 Paris, France