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ClinicalTrials.gov ID

NCT07065929

Lead Sponsor

University Hospital, AngersOTHER_GOV

Overall Status

Recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

3,084Estimated

Last Update Posted

Jan 8, 2026Actual

Start Date

Sep 19, 2025Actual

Primary Completion Date

Sep 2027Estimated

Completion Date

Dec 2027Estimated

Official Title

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

Brief Summary

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.

• Acute Stroke

• Early nutritional management

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility 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

Primary Purpose

Supportive Care

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

University Hospital, AngersOTHER_GOV

deleand-a@chu-caen.fr02 31 06 39 21 ext. +33

siriane.Landry@chu-rouen.fr02 32 88 89 90 ext. +33