Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07065929

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

Led by University Hospital, Angers · Updated on 2026-01-08

3084

Participants Needed

12

Research Sites

114 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

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
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

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Trial Site Locations

Total: 12 locations

1

CH Versailles

Chesnay, Yvelines, France, 78150

Actively Recruiting

2

CHU Angers

Angers, France, 49933

Actively Recruiting

3

CHU Caen

Caen, France, 14033

Actively Recruiting

4

CH Cholet

Cholet, France, 49300

Actively Recruiting

5

CHD La Roche sur Yon

La Roche-sur-Yon, France, 85925

Not Yet Recruiting

6

CH La Rochelle

La Rochelle, France, 17000

Actively Recruiting

7

CH Chartres

Le Coudray, France, 28630

Actively Recruiting

8

CHU Rouen

Rouen, France, 76000

Actively Recruiting

9

CHU Nantes

Saint-Herblain, France, 44800

Not Yet Recruiting

10

CH St Malo

St-Malo, France, 35043

Actively Recruiting

11

CHU Toulouse

Toulouse, France, 31059

Not Yet Recruiting

12

CHU Tours

Tours, France, 37000

Not Yet Recruiting

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Research Team

A

Angélique CAMPION

CONTACT

A

Anthéa LOIEZ

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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