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

Status: Recruiting
Location: See all (12) locations...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
CHU Angers
RECRUITING
Angers
CHU Caen
NOT_YET_RECRUITING
Caen
CH Versailles
NOT_YET_RECRUITING
Chesnay
CH Cholet
NOT_YET_RECRUITING
Cholet
CHD La Roche sur Yon
NOT_YET_RECRUITING
La Roche-sur-yon
CH La Rochelle
NOT_YET_RECRUITING
La Rochelle
CH Chartres
NOT_YET_RECRUITING
Le Coudray
CHU Rouen
NOT_YET_RECRUITING
Rouen
CHU Nantes
NOT_YET_RECRUITING
Saint-herblain
CH St Malo
NOT_YET_RECRUITING
St-malo
CHU Toulouse
NOT_YET_RECRUITING
Toulouse
CHU Tours
NOT_YET_RECRUITING
Tours
Contact Information
Primary
Angélique CAMPION
Angelique.Campion@chu-angers.fr
02 41 35 36 37
Backup
Anthéa LOIEZ
DRCI-Promotion-Interne@chu-angers.fr
02 41 35 36 37
Time Frame
Start Date: 2025-09-19
Estimated Completion Date: 2027-12
Participants
Target number of participants: 3084
Treatments
Experimental: Interventional Group
early nutritional management
No_intervention: Control Group
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Angers

This content was sourced from clinicaltrials.gov