Follow-up of Malnutrition Screening in USINV (DENUTRITION)

Follow-up of Malnutrition Screening in Neurovascular Intensive Care Unit

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Stroke

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 Type: Observational
• Enrollment (Actual): 66

Contacts and Locations

Study Locations

• France
  • Paris, France, 75014
    • Groupe Hospitalier Paris Saint-Joseph

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients hospitalized in Neurovascular Intensive care Unit following a stroke

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients in neurovascular intensive care; During the patient's hospitalization in neurovascular intensive care unit, the doctor will propose to the patient to take part in this study. If the patient agree, this search will not change the patient's usual support and will not involve any further review.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Groupe Hospitalier Paris Saint Joseph
• Investigators: Principal Investigator: Marie P BRUANDET, MD, Groupe hospitalier Paris saint Joseph

Study record dates

Study Major Dates

• Study Start (Actual): May 29, 2018
• Primary Completion (Actual): August 30, 2019
• Study Completion (Anticipated): December 30, 2023

Study Registration Dates

• First Submitted: October 31, 2018
• First Submitted That Met QC Criteria: October 31, 2018
• First Posted (Actual): November 2, 2018

Study Record Updates

• Last Update Posted (Estimate): March 7, 2023
• Last Update Submitted That Met QC Criteria: March 6, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition
• Other Study ID Numbers: DENUTRITION USINV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No