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NCT07065929Recruiting

Impact of Early, Personalized Nutritional Management on 1-month Mortality After Acute Stroke

Impact of Early, Personalized Nutritional Management on 1-month Mortality After Acute Stroke Pragmatic, Controlled, Multicenter, Cluster-randomized Trial

Source: ClinicalTrials.gov · Last updated 1 Sept 2026

Brief summary (registry, in English)

This study evaluate the impact of early personalized nutritional management on 1-month mortality after acute stroke. In the randomised centres of the interventional group (early personalized nutritional management), each patient will be assessed by a dietician within 2 days of stroke. Any swallowing problems are screened, and any barriers to eating are identified before dietary support. Patient's food intakes are recorded until the 7th day post-acute to assess their energy intake. Depending on patient's nutritional objectives, a reinforced feeding strategy comprising 2 levels is put in place, in order to prevent malnutrition: in level 1, the dietician tries to meet nutritional requirements orally, while in level 2 he can recourse to artificial nutrition in the event of failure or inability to meet requirements with oral intake alone. This strategy is started immediately after the initial assessment. Intakes are reassessed every 24 to 48 hours by the dietician in order to adapt the nutritional strategy as quickly as possible in order to cover the patient's personnalized nutritional needs. No change in practice was required of the randomised centres in the control group. All patients will be contacted by telephone 30 days after stroke to collect parts of the assessment criteria, while the other criteria will be collected directly from the patient's computerised medical record. Three months after stroke, an evaluation of quality of life and modified Rankin test will be performed. Our hypothesis is that the implementation of an individualized management of early nutritional support, aimed at compensating for the decrease in intake associated with the disease, would reduce mortality at 30 days in patients hospitalised for stroke.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
3084 (estimated)
First submitted
27 May 2025
Start date
Sept 2025
Primary completion date
Sept 2027
Lead sponsor
University Hospital, Angers
Diseases
Stroke
NCT number
NCT07065929

What you commit to

  • Study type: Interventional
  • Planned participants: 3084
  • From Sept 2025 to the primary completion date, Sept 2027
  • 12 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.).
  • Previous inclusion in the trial

Other illness

  • Patient under compulsory psychiatric care

Other

  • In a palliative situation where life expectancy is \< 3 months
  • Patient taking part in another study with an impact on mortality or nutrition
  • Pregnant, breast-feeding or parturient woman
  • Patient unable to follow the protocol for any reason
  • Patient deprived of liberty by judicial or administrative decision
  • Person under legal protection
  • Poor understanding of the French language

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (12)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CHU Angers
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AngersFranceRecruiting
CHU Caen
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CaenFranceRecruiting
CH Versailles
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ChesnayFranceRecruiting
CH Cholet
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CholetFranceRecruiting
CH La Rochelle
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La RochelleFranceRecruiting
Chd La Roche Sur Yon
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La Roche-sur-YonFranceRecruiting
CH Chartres
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Le CoudrayFranceRecruiting
CHU Rouen
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RouenFranceRecruiting
CHU Nantes
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Saint-HerblainFranceNot yet recruiting
CH St Malo
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St-MaloFranceRecruiting
CHU Toulouse
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ToulouseFranceRecruiting
CHU Tours
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ToursFranceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.