Back to resultsRole of Nutrition in Patients Over 75 Years of Age With Stroke (INFRA)
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
completion of a quality of life questionnaire
Sponsored by
About this trial
This is an interventional other trial for Stroke
Eligibility Criteria
Inclusion Criteria:
- Patients with symptomatic stroke defined according to WHO criteria (including cerebral infarction and intracerebral haemorrhage) managed at the stroke ICU, Neurology 1, Neurology 2, Internal Medicine 2 or Geriatrics at Dijon CHU during the period from 1st November 2015 to 30th September 2016.
- Patients aged 75 years and older.
- Patients who have provided informed consent to take part in the study.
Exclusion Criteria:
- Patients with meningeal haemorrhage or TIA.
- Patients who refuse to take part in the study.
- Patients with hypo-albuminemia not related to malnutrition: chronic infectious or inflammatory syndrome, nephrotic syndrome, exudative enteropathy, hydration disorders.
- Subjects in custody.
- Patients (or person of trust) who cannot be contacted by telephone during the follow-up.
Sites / Locations
- Centre Hospitalier Universitaire
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
patient
Arm Description
Outcomes
Primary Outcome Measures
Mortality rate
Secondary Outcome Measures
Full Information
NCT ID
NCT02856009
First Posted
August 2, 2016
Last Updated
October 9, 2017
Sponsor
Centre Hospitalier Universitaire Dijon
1. Study Identification
Unique Protocol Identification Number
NCT02856009
Brief Title
Role of Nutrition in Patients Over 75 Years of Age With Stroke
Acronym
INFRA
Official Title
Impact of Nutritional Status and Frailty on the Prognosis of Patients Over 75 Years Old Who Suffered a Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
November 2015 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire Dijon
4. Oversight
5. Study Description
Brief Summary
Stroke in elderly subjects has a more severe clinical presentation (in terms of frequency of aphasia, hemiplegia or consciousness disorders), and a worse functional and vital prognosis. Patients older than 75 years also show excess mortality. One of the hypotheses to explain this situation is the high level of frailty in this population. Many tools to measure the concept of frailty have been developed. One important dimension of these tools is the nutritional status. Indeed, protein-energy malnutrition in the elderly, though a frequent situation, is also a complex phenomenon.
The aim of this study is therefore to analyse the impact of protein-energy malnutrition, as a marker of frailty, on the early prognosis (at 28 days) in the aftermath of stroke in subjects older than 75 years hospitalized in Dijon CHU.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
177 (Actual)
8. Arms, Groups, and Interventions
Arm Title
patient
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
completion of a quality of life questionnaire
Primary Outcome Measure Information:
Title
Mortality rate
Time Frame
Day 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with symptomatic stroke defined according to WHO criteria (including cerebral infarction and intracerebral haemorrhage) managed at the stroke ICU, Neurology 1, Neurology 2, Internal Medicine 2 or Geriatrics at Dijon CHU during the period from 1st November 2015 to 30th September 2016.
Patients aged 75 years and older.
Patients who have provided informed consent to take part in the study.
Exclusion Criteria:
Patients with meningeal haemorrhage or TIA.
Patients who refuse to take part in the study.
Patients with hypo-albuminemia not related to malnutrition: chronic infectious or inflammatory syndrome, nephrotic syndrome, exudative enteropathy, hydration disorders.
Subjects in custody.
Patients (or person of trust) who cannot be contacted by telephone during the follow-up.
Facility Information:
Facility Name
Centre Hospitalier Universitaire
City
Dijon
ZIP/Postal Code
21079
Country
France
12. IPD Sharing Statement
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Role of Nutrition in Patients Over 75 Years of Age With Stroke
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