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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

3084 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-19

Study Completion Date

2027-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Acute Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

cluster randomisation in parallel arms

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Interventional Group

early nutritional management

Group Type EXPERIMENTAL

Early nutritional management

Intervention Type DIETARY_SUPPLEMENT

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.

Control Group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No