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RECRUITING
NCT07065929
NA

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

Sponsor: University Hospital, Angers

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

3084

Start Date

2025-09-19

Completion Date

2027-12

Last Updated

2026-01-08

Healthy Volunteers

No

Conditions

Interventions

DIETARY_SUPPLEMENT

Early nutritional management

The food ingested by patients is collected until the day 7 of the stroke so that dieticians can calculate their needs and provide a suitable diet. If this is not sufficient, a reinforced nutrition strategy (meal enrichment) is implemented. On day 5 of the stroke, if energy intake is less than 2/3 of the energy objectives, the strategy is switched to level 2, unless it is possible to increase intake within 48 hours.

Locations (12)

CH Versailles

Chesnay, Yvelines, France

CHU Angers

Angers, France

CHU Caen

Caen, France

CH Cholet

Cholet, France

CHD La Roche sur Yon

La Roche-sur-Yon, France

CH La Rochelle

La Rochelle, France

CH Chartres

Le Coudray, France

CHU Rouen

Rouen, France

CHU Nantes

Saint-Herblain, France

CH St Malo

St-Malo, France

CHU Toulouse

Toulouse, France

CHU Tours

Tours, France