Impact of Early, Personalized Nutritional Management on 1-month Mortality After Acute Stroke (NCT07065929) | Clinical Trial Compass
RecruitingNot Applicable
Impact of Early, Personalized Nutritional Management on 1-month Mortality After Acute Stroke
France3,084 participantsStarted 2025-09-19
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria :
* 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
Exclusion Criteria:
* 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
* Previous inclusion in the trial
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
mortality at 30 days after stroke (main criterion)