Role of Nutrition in Patients Over 75 Years of Age With Stroke

Stroke Clinical Trial

— INFRA  

Official title:

Impact of Nutritional Status and Frailty on the Prognosis of Patients Over 75 Years Old Who Suffered a Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02856009
• Other study ID #: Béjot 2015
• Status: Completed
• Phase: N/A
• First received: August 2, 2016
• Last updated: October 9, 2017
• Start date: November 2015
• Est. completion date: December 2016

Study information

• Verified date: July 2016
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 177
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• completion of a quality of life questionnaire

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality rate		Day 28