Early personalized nutrition to reduce one-month mortality after acute stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, center-based intervention compares early, personalized nutritional management to usual care for adults hospitalized with acute ischemic or hemorrhagic stroke and NIHSS ≥ 5. In the intervention arm a dietitian evaluates patients within 48 hours, screens for swallowing problems, records food intake daily through day 7, and implements a two-level reinforced feeding strategy that attempts to meet energy needs orally or uses artificial nutrition if oral intake is insufficient. Intake and feeding plans are reassessed every 24–48 hours and adjusted to patient needs. The primary outcome is mortality at one month after the stroke.

Why it matters

Who can join: the full rules

Inclusion Criteria :

* Patients ≥ 18 years of age
* With an acute, ischaemic or haemorrhagic outpatient or inpatient stroke
* NIHSS score ≥ 5
* Hospitalised in a neurology department, or Neuro Vascular Unit (NVU), or in a department where beds are dedicated to receiving post-stroke patients
* Stroke less than 2 days old
* Anticipated length of hospital stay in a participating centre ≥ 5 days
* Patient affiliated to or benefiting from a social security scheme
* Patient or close relative having given written consent to participate in the study or patient included under the emergency procedure in the absence of contactable relatives or patients enrolled under the emergency protocol when no family members were present within 2 days of the stroke.

Exclusion Criteria:

* Patients treated with nutritional therapy at the time of admission (history of bariatric surgery or gastrectomy, malabsorptive pathologies such as short bowel, extensive intestinal resections, etc.).
* In a palliative situation where life expectancy is \< 3 months
* Patient taking part in another study with an impact on mortality or nutrition
* Previous inclusion in the trial
* Pregnant, breast-feeding or parturient woman
* Patient unable to follow the protocol for any reason
* Patient deprived of liberty by judicial or administrative decision
* Patient under compulsory psychiatric care
* Person under legal protection
* Poor understanding of the French language

Where it's running

• CH Versailles
  Chesnay, Yvelines, France Recruiting
• CHU Angers
  Angers, France Recruiting
• CHU Caen
  Caen, France Recruiting
• CH Cholet
  Cholet, France Recruiting
• CHD La Roche sur Yon
  La Roche-sur-Yon, France Recruiting
• CH La Rochelle
  La Rochelle, France Recruiting

Study contacts

• Principal investigator: Angélique CAMPION — University Hospital, Angers
• Study coordinator: Angélique CAMPION
• Email: Angelique.Campion@chu-angers.fr
• Phone: 02 41 35 36 37

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.