Early personalized nutrition to reduce one-month mortality after acute stroke
Impact of Early, Personalized Nutritional Management on 1-month Mortality After Acute Stroke Pragmatic, Controlled, Multicenter, Cluster-randomized Trial
This trial tests if giving personalized nutritional support within 2 days of an acute stroke can reduce the risk of dying within one month.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 3084 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Angers Government |
| Locations | 12 sites (Chesnay, Yvelines and 11 other locations) |
| Trial ID | NCT07065929 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18) with an acute ischemic or hemorrhagic stroke within 2 days, NIHSS ≥ 5, admitted to a neurology/Neuro Vascular Unit or designated post-stroke bed and expected to stay ≥5 days are ideal candidates.
Not a fit: Patients already receiving nutritional therapy on admission, those in palliative care with life expectancy under three months, or those discharged too quickly to receive dietitian-led follow-up are unlikely to benefit.
Why it matters
Potential benefit: If successful, this approach could lower one-month death rates and reduce early complications related to inadequate nutrition after stroke.
How similar studies have performed: Previous work shows early nutritional support can improve intake and some functional or complication outcomes, but effects on short-term mortality are mixed and personalized early strategies remain incompletely tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 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 this trial is running
Chesnay, Yvelines and 11 other locations
- 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 (Not_yet_recruiting)
- CH La Rochelle — La Rochelle, France (Recruiting)
- CH Chartres — Le Coudray, France (Recruiting)
- CHU Rouen — Rouen, France (Recruiting)
- CHU Nantes — Saint-Herblain, France (Not_yet_recruiting)
- CH St Malo — St-Malo, France (Recruiting)
- CHU Toulouse — Toulouse, France (Not_yet_recruiting)
- CHU Tours — Tours, France (Not_yet_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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.