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

Study acronym: AVC-NUT2
StatusRecruiting
PhaseNot applicable
Started2025-09-19
View on ClinicalTrials.gov ↗

Amendment history

2026-08-27
minor
Study Status, Outcome Measures, Eligibility, Contacts/Locations v4
Eligibility criteria+115 characters
[...] emergency procedure in the absence of contactable relatives or patients enrolled under the emergency protocol when no family members were present within 2 days of the stroke. Exclusion Criteria: Patients treated with nutritional thera [...]
Secondary endpoints7 to 8 entries
Time to occurrence of inhalation pneumonia associated with swallowing disorders recorded within 30 days of the day of the stroke
Study sitesdetails revised at 3 of 12 sites
2026-01-06
minor
Study Status, Contacts/Locations, IPDSharing v3
Study sitesdetails revised at 7 of 12 sites
2025-09-24
minor
Study Status v2
Start date2025-09-17→2025-09-19
2025-09-17
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2027-08→2027-09
Completion date2027-11→2027-12
Start dateestimated 2025-08→confirmed 2025-09-17
Study sitesdetails revised at 12 of 12 sites
2025-07-11
minor
Original filing
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 Details
NCT Number NCT07065929
Lead Sponsor University Hospital, Angers
Conditions Acute Stroke
Enrollment 3,084 participants
Start Date 2025-09-19
Primary Completion 2027-09 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2026-09-01