NCT07065929

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 3,084 (estimated)
• Sponsor: University Hospital, Angers · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Stroke

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-09-19
• Primary completion: 2027-09-01
• Completion: 2027-12-01
• First posted: 2025-07-15
• Last updated: 2026-01-08

Locations

12 sites across 1 country: France