Impact of Early, Personalized Nutritional Management on 1-month Mortality After Acute Stroke
AVC-NUT2
2 other identifiers
interventional
3,084
1 country
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2025
Typical duration for not_applicable
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 27, 2025
CompletedFirst Posted
Study publicly available on registry
July 15, 2025
CompletedStudy Start
First participant enrolled
September 19, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
January 8, 2026
January 1, 2026
2 years
May 27, 2025
January 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
mortality at 30 days after stroke (main criterion)
Recording patient status at 30 days after stroke
At 30 days of the day of the stroke
Secondary Outcomes (7)
Proportion of patients with modified Rankin score ≤ 2, 3 months after stroke
At 90 days of the day of the stroke
Nutritional status at 30 days defined by BMI, weight change over 30 days and albumin rate, used to classify patients as severely undernourished, moderately undernourished or not undernourished.
At 30 days of the day of the stroke
Time to occurrence of inhalation pneumonia related to the presence of a feeding tube recorded within 30 days of the day of the stroke
Within 30 days of the day of the stroke
Time to occurrence of infection related to a catheter dedicated to parenteral nutrition recorded within 30 days of the day of the stroke
Within 30 days of the day of the stroke
Time to occurrence of death recorded within 30 days of the day of the stroke:
Within 30 days of the day of the stroke
- +2 more secondary outcomes
Study Arms (2)
Interventional Group
EXPERIMENTALearly nutritional management
Control Group
NO INTERVENTIONInterventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
CH Versailles
Chesnay, Yvelines, 78150, France
CHU Angers
Angers, 49933, France
CHU Caen
Caen, 14033, France
CH Cholet
Cholet, 49300, France
CHD La Roche sur Yon
La Roche-sur-Yon, 85925, France
CH La Rochelle
La Rochelle, 17000, France
CH Chartres
Le Coudray, 28630, France
CHU Rouen
Rouen, 76000, France
CHU Nantes
Saint-Herblain, 44800, France
CH St Malo
St-Malo, 35043, France
CHU Toulouse
Toulouse, 31059, France
CHU Tours
Tours, 37000, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Angélique CAMPION
University Hospital, Angers
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 27, 2025
First Posted
July 15, 2025
Study Start
September 19, 2025
Primary Completion (Estimated)
September 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
January 8, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- The data will be shared after signing a negotiated data transfer agreement ( data access agreement), for the duration specified in the agreement.
- Access Criteria
- The data will be made available via secure transfer (sharing platform approved by the university hospital: BlueFiles or Oodrive).
Data will be shared upon reasonable request. Only de-identified data will be shared. Any data collected during the study may be shared. The protocol will be shared initially. Other documents may be shared at a later date upon request (e.g., the CRF to allow a collaborator to select the data they wish to access). The recipients of the data will be researchers. The data will be available for any purpose deemed relevant by the study investigator, based on a protocol provided by the requester, after verification of the obtaining of regulatory approvals, including the favorable opinion of an ethics committee.