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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-A00234-45 | Other Identifier | ANSM |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional Group | Experimental | early nutritional management |
|
| Control Group | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early nutritional management | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with modified Rankin score ≤ 2, 3 months after stroke | Modified Rankin score is evaluated at 3 months after stroke and a percentage of patients with a score < 2 will be calculated | 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. |
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Inclusion Criteria :
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Angélique CAMPION | Contact | 02 41 35 36 37 | +33 | Angelique.Campion@chu-angers.fr |
| Anthéa LOIEZ | Contact | 02 41 35 36 37 | +33 | DRCI-Promotion-Interne@chu-angers.fr |
| Name | Affiliation | Role |
|---|---|---|
| Angélique CAMPION | University Hospital, Angers | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH Versailles | Recruiting | Chesnay | Yvelines | 78150 | France |
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.
The data will be shared after signing a negotiated data transfer agreement ( data access agreement), for the duration specified in the agreement.
The data will be made available via secure transfer (sharing platform approved by the university hospital: BlueFiles or Oodrive).
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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cluster randomisation in parallel arms
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|
| 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 | Recording of inhalation pneumonia related to the presence of a feeding tube | 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 | Recording of infection related to a catheter dedicated to parenteral nutrition | Within 30 days of the day of the stroke |
| Time to occurrence of death recorded within 30 days of the day of the stroke: | Recording of death | Within 30 days of the day of the stroke |
| Hospital stay (in days) with censoring at 3 months after stroke | Calculation of the number of days of hospitalisation between the stoke and the date of discharge from the Department | Length of hospitalization (in days), calculated between the stroke 's date (day 0) and the date of discharge from the Neurology Department, assessed up to 90 days after the stroke. |
| Evaluation of the variation in the EuroQol 5D quality of life score (EQ-5D-5L) between the pre-stroke period and 3 months after stroke | Estimated quality of life scores before the stroke and at 3 months post-stroke are obtained using EuroQol 5D-5L questionnaires completed with patients or their close relative at 3 month after stroke | At 90 days of the day of the stroke |
| CHU Angers | Recruiting | Angers | 49933 | France |
|
| CHU Caen | Recruiting | Caen | 14033 | France |
|
| CH Cholet | Recruiting | Cholet | 49300 | France |
|
| CHD La Roche sur Yon | Not yet recruiting | La Roche-sur-Yon | 85925 | France |
|
| CH La Rochelle | Recruiting | La Rochelle | 17000 | France |
|
| CH Chartres | Recruiting | Le Coudray | 28630 | France |
|
| CHU Rouen | Recruiting | Rouen | 76000 | France |
|
| CHU Nantes | Not yet recruiting | Saint-Herblain | 44800 | France |
|
| CH St Malo | Recruiting | St-Malo | 35043 | France |
|
| CHU Toulouse | Not yet recruiting | Toulouse | 31059 | France |
|
| CHU Tours | Not yet recruiting | Tours | 37000 | France |
|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |